Brain
AFT-28 CANVAS
Primary Category:
Cancer Control and Prevention Protocols
Disease Category:
Brain, Breast, Chronic Lymphocytic Leukemia, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Lung, Lymphoma, Melanoma, Multiple Myeloma, Neuroendocrine, Sarcoma
Direct Oral Anticoagulants (DOACs) versus LMWH +/- Warfarin for VTE in Cancer: A Randomized Effectiveness Trial (CANVAS Trial)
NCT#02744092
(Click for More Info)
Limited institution study – Only open to: Benefis Sletten Cancer Institute, Billings Clinic, Bozeman Health, Community Hospital of Anaconda, Community Medical Center, Kalispell Regional Medical Center, Kootenai Health, & Saint Alphonsus Regional Medical Center.
Sites must submit to MCC an AFT Delegation of Authority Log before any patient registrations may take place.
AFT-39 PROTECT
Primary Category:
Cancer Control and Prevention Protocols
Disease Category:
Anal, Bladder, Brain, Breast, Carcinoid, Cervical, Cholangiocarcinoma, Colon, Colon Metastatic, Endometrial, Esophageal, Gallbladder, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Liver, Lung, Lung - Non-Small Cell, Lung - Small Cell, Lymphoma, Melanoma, Multiple Myeloma, Neuroendocrine, Ovarian, Pancreatic, Prostate, Rectal, Renal, Sarcoma, Stomach, Thyroid, Uterine
Electronic patient reporting of symptoms during outpatient cancer treatment: A U.S. national randomized controlled trial (the “PRO-TECT” trial)
NCT#03249090
(Click for More Info)
Limited institution study – Only open to: Billings Clinic & Bozeman Health
Effective, October 25th, 2019, the CONTROL arm of AFT 39, is closed to accrual.
ALLIANCE A071102
Primary Category:
Treatment Protocols
A Phase II/III Randomized Trial Of Veliparib Or Placebo In Combination With Adjuvant
Temozolomide In Newly Diagnosed Glioblastoma With MGMT Promoter Hypermethylation
The study has accrued the sufficient number of patients to meet the enrollment goal. Therefore, effective Monday, October 15, 2018 Alliance A071102 will be permanently closed to new patient registration (Step 1).
The phase III portion of A071102 will soon meet its accrual goal. Therefore, EFFECTIVE Friday, May 18, 2018 at 4:00 PM ET, A071102 will be PERMANENTLY CLOSED to new patient pre-registration (Step 0).
NCT#02152982
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ALLIANCE A071401
Primary Category:
Treatment Protocols
Status:
Temporarily Closed
Phase II Trial of SMO / AKT / NF2 Inhibitors in Progressive Meningiomas with SMO / AKT / NF2 Mutations
The A071401 NF2 Grade I and NF2 Grade II/III cohorts have met their accrual goals. Therefore, EFFECTIVE 07/19/17, no new patients may register (Step 1) to the NF2 Grade I or Grade II/III cohorts.
NCT#02523014
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Effective immediately on 02/07/18, pre-registration (Step 0) and registration (Step 1) to A071401 have been temporarily suspended. The manufacturer of the investigational agent vismodegib has discontinued provision to new patients on A071401. Therefore, effectively immediately, the SMO/PTCH1 Grade I and SMO/PTCH1 Grade II/III cohorts on A071401 are closed to new patient registration (Step 1).
ALLIANCE A071601
Primary Category:
Treatment Protocols
Phase II Trial of BRAF/MEK Inhibitors in Papillary Craniopharyngiomas
NCT#03224767
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ALLIANCE A071701
Primary Category:
Treatment Protocols
Disease Category:
Brain, Brain Metastatic, Molecular Profiling
Genomically-Guided Treatment Trial in Brain Metastases
(Click for More Info)
ALLIANCE A071801
Primary Category:
Radiation Oncology
Disease Category:
Brain, Brain Metastatic
Phase III Trial of Post-Surgical Single Fraction Stereotactic Radiosurgery (SRS) Compared With Fractionated SRS for Resected Metastatic Brain Disease
NCT#04114981
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ALLIANCE A221208
Primary Category:
Cancer Control and Prevention Protocols, Radiation Oncology
Disease Category:
Brain Metastatic
Randomized Phase II Study: Corticosteroids and Bevacizumab vs. Corticosteroids and Placebo (BeSt) for Radionecrosis after Radiosurgery for Brain Metastases
The Alliance Data Safety Monitoring Board has directed that A221208 be closed due to poor accrual, as it is unlikely to reach its accrual goal. Therefore, EFFECTIVE Wednesday, November 21, 2018, at 4:30 pm ET, A221208 will permanently close to new patient pre-registration. Patients who are screened and consented need to be pre-registered on or before November 21, 2018. Sites will not be allowed pre-register new patients after this date.
Eligible for screening study DCP 001
NCT#02490878
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ALLIANCE CCTG CE.7
Primary Category:
Radiation Oncology
Disease Category:
Brain, Brain Metastatic
A Phase III Trial of Stereotactic Radiosurgery Compared with Hippocampal-Avoidant Whole Brain Radiotherapy (HA-WBRT) Plus Memantine for 5-15 Brain Metastases
For CCTG CE.7, please credit ALLIANCE all accruals.
NCT#03550391
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CCTG CE.7 has reopened with Amendment 1 to resume patient accrual at your center, your site will be required to provide confirmation of HA-WBRT credentialing and approval by IROC.
ALLIANCE N0577
Primary Category:
Radiation Oncology, Treatment Protocols
Phase III Intergroup Study of Temozolomide Alone versus Radiotherapy with Concomitant and Adjuvant Temozolomide versus Radiotherapy with Adjuvant PCV Chemotherapy in Patients with 1p/19q Co-deleted Anaplastic Glioma
Eligible for screening study DCP 001
MCC is a legacy NCCTG institution and site must offer patient participation in N0392 QOL study prior to randomization on N0577. See N0392 protocol page for separate consent form and additional information.
NCT#00887146
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ECOG-ACRIN EAQ152
Primary Category:
Cancer Control and Prevention Protocols
Disease Category:
Brain, Breast, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Lung, Lymphoma, Melanoma, Molecular Profiling, Other, Sarcoma
COMET – Communication and Education in Tumor Profiling: A Randomized Study of Pre-disclosure Genetic Education v. Usual Care in Tumor Profiling for Advanced Cancer and a Pilot Study of Remote Genetic Counseling for Participants with Potential Germline Mutations Identified on Tumor Profiling
(Sub-study for EAY131)
Eligible for screening study DCP 001
NCT#02823652
(Click for More Info)
MCC not eligible to participate in new addendum, as EAQ152 is only open to accrual at select sites.
ECOG-ACRIN EAY131
Primary Category:
Treatment Protocols
Disease Category:
Brain, Breast, Carcinoid, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Lung, Lymphoma, Melanoma, Molecular Profiling, Other, Sarcoma
Molecular Analysis for Therapy Choice (MATCH)
Eligible for screening study DCP 001
NCT#02465060
(Click for More Info)
The protocol allows designated private sector laboratories to refer patients to the study based on genetic testing performed independent of MATCH. This is limited to genetic testing ordered for patients at approved MATCH trial sites. Approved genetic testing laboratories and their date of inclusion in the outside assay process are:
- CARIS Life Sciences – 07/02/18
- CellNetix Pathology and Laboratories – 02/13/19
- Foundation Medicine – 07/02/18
- GenPath BioReference Laboratories – 08/03/18
- The Jackson Laboratory – 01/10/19
- NeoGenomics Laboratories – 07/02/18
- OmniSeq Laboratories – 07/16/18
- PathGroup – 10/29/18
- Quest Diagnostics Inc. – 05/20/19
- Strata Oncology – 08/03/18
- Tempus Laboratories – 07/16/18
The Biopsy consent form for this study is available upon request. Please contact Amber Boerner, aboerner@mtcancer.org or 406-969-6067, for the consent & for any questions.
(http://ecog-acrin.org/nci-match-eay131-designated-labs)
NRG BN003
Primary Category:
Radiation Oncology, Treatment Protocols
Phase III Trial of Observation Versus Irradiation for a Gross Totally Resected Grade II Meningioma
Eligible for screening study DCP 001
NCT#03180268
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NRG CC003
Primary Category:
Radiation Oncology
Disease Category:
Brain, Lung, Lung - Small Cell, Lung - Small Cell Extensive Stage, Lung - Small Cell Limited Stage
Randomized Phase II/III Trial of Prophylatic Cranial Irradiation With or Without Hippocampal Avoidance for Small Cell Lung Cancer
NCT#02635009
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Eligible for screening study DCP 001
Reactivation to Phase III accrual as of 01/09/19.
SWOG S1614
Primary Category:
Cancer Control and Prevention Protocols
Disease Category:
Brain, Breast, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Lung, Neuroendocrine, Other, Sarcoma, Skin, Thyroid
A Phase III Randomized Trial of Prophylactic Antiviral Therapy in Patients with Current or Past Hepatitis B Virus (HBV) Infection Receiving Anti-Cancer Therapy for Solid Tumors
NCT#03887702
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SWOG S1916
Primary Category:
Cancer Control and Prevention Protocols
Disease Category:
Brain, Breast, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Leukemia, Lung, Lymphoma, Multiple Myeloma, Neuroendocrine, Sarcoma, Skin, Thyroid
Status:
Upcoming - Pending IRB Review
Feasibility of a Digital Medicine Program in Optimizing Opioid Pain Control in Cancer Patients
Limited site participation. Open only to Billings Clinic.
Please see the SWOG website for any study documents not found here on the MCC website.
Breast
AFT-25 COMET
Primary Category:
Radiation Oncology, Surgical Protocols, Treatment Protocols
Disease Category:
Breast, Breast DCIS
Comparison of Operative to Monitoring and Endocrine Therapy (COMET) Trial For Low Risk DCIS: A Phase III Prospective Randomized Trial
NCT#02926911
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Limited institution study – Only open to: Benefis Sletten Cancer Institute, Billings Clinic, Bozeman Health, Community Hospital of Anaconda, Community Medical Center, Kalispell Regional Medical Center, Kootenai Health, & Saint Alphonsus Regional Medical Center.
Sites must submit to MCC a protocol specific Training Log and an AFT Delegation of Authority Log before any patient registrations may take place.
AFT-28 CANVAS
Primary Category:
Cancer Control and Prevention Protocols
Disease Category:
Brain, Breast, Chronic Lymphocytic Leukemia, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Lung, Lymphoma, Melanoma, Multiple Myeloma, Neuroendocrine, Sarcoma
Direct Oral Anticoagulants (DOACs) versus LMWH +/- Warfarin for VTE in Cancer: A Randomized Effectiveness Trial (CANVAS Trial)
NCT#02744092
(Click for More Info)
Limited institution study – Only open to: Benefis Sletten Cancer Institute, Billings Clinic, Bozeman Health, Community Hospital of Anaconda, Community Medical Center, Kalispell Regional Medical Center, Kootenai Health, & Saint Alphonsus Regional Medical Center.
Sites must submit to MCC an AFT Delegation of Authority Log before any patient registrations may take place.
AFT-39 PROTECT
Primary Category:
Cancer Control and Prevention Protocols
Disease Category:
Anal, Bladder, Brain, Breast, Carcinoid, Cervical, Cholangiocarcinoma, Colon, Colon Metastatic, Endometrial, Esophageal, Gallbladder, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Liver, Lung, Lung - Non-Small Cell, Lung - Small Cell, Lymphoma, Melanoma, Multiple Myeloma, Neuroendocrine, Ovarian, Pancreatic, Prostate, Rectal, Renal, Sarcoma, Stomach, Thyroid, Uterine
Electronic patient reporting of symptoms during outpatient cancer treatment: A U.S. national randomized controlled trial (the “PRO-TECT” trial)
NCT#03249090
(Click for More Info)
Limited institution study – Only open to: Billings Clinic & Bozeman Health
Effective, October 25th, 2019, the CONTROL arm of AFT 39, is closed to accrual.
ALLIANCE A011106
Primary Category:
Treatment Protocols
Disease Category:
Breast, Breast Neoadjuvant
ALTernate approaches for clinical stage II or III Estrogen Receptor positive breast cancer NeoAdjuvant TrEatment (ALTERNATE) in postmenopausal women: A Phase III Study
Eligible for screening study DCP 001
NCT#01953588
(Click for More Info)
Effective today, July 15th, 2019, study A011106 is permanently closed to new patient registration.
ALLIANCE A011202
Primary Category:
Radiation Oncology, Surgical Protocols, Treatment Protocols
Disease Category:
Adjuvant Breast, Breast
Status:
Temporarily Closed
A Randomized Phase III Trial Comparing Axillary Lymph Node Dissection to Axillary Radiation in Breast Cancer Patients (cT1-3 N1) Who Have Positive Sentinel Lymph Node Disease After Neoadjuvant Chemotherapy
Eligible for screening study DCP 001
The protocol-specified number of patients to be pre-registered has been met. Therefore, Alliance A011202 has been temporarily suspended to new patient pre registration (Step 0) EFFECTIVE IMMEDIATELY, Thursday, April 18, 2019. The protocol will be amended to increase the number of pre-registrations required to meet its registration accrual goal.
NCT#01901094
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ALLIANCE A011203
Primary Category:
Treatment Protocols
Disease Category:
Breast, Breast Metastatic
A Randomized Phase II Trial of Tamoxifen Versus Z-Endoxifen HCL in Postmenopausal Women with Metastatic Estrogen Receptor Positive, HER2 Negative Breast Cancer
NCT#02311933
(Click for More Info)
A011203 will soon meet its accrual goal. Therefore, EFFECTIVE MONDAY, April 17, 2017 at 4:30 pm ET, A011203 Pre-registration will permanently close to new patient accrual.
ALLIANCE A011401
Primary Category:
Cancer Control and Prevention Protocols
Disease Category:
Adjuvant Breast, Breast, Breast Neoadjuvant
Randomized Phase III Trial Evaluating the Role of Weight Loss in Adjuvant Treatment of Overweight and Obese Women with Early Breast Cancer
Eligible for screening study DCP 001
NCT#02750826
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The A011401 Health Behaviors and Patient Reported Outcomes substudy HO1 will soon meet its study accrual goal. Therefore, EFFECTIVE July 06, 2017 at 4:30 pm ET, A011401 substudy HO1 will permanently close to new patient accrual.
ALLIANCE A011502
Primary Category:
Cancer Control and Prevention Protocols, Treatment Protocols
Disease Category:
Adjuvant Breast, Breast
A Randomized Phase III Double-Blinded Placebo Controlled Trial of Aspirin as Adjuvant Therapy for Node Positive HER2 Negative Breast Cancer: The ABC Trial
See Companion Study A211601
Eligible for screening study DCP 001
NCT#02927249
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ALLIANCE A171601
Primary Category:
Treatment Protocols
Disease Category:
Breast, Breast Metastatic
A Phase II Trial Assessing the Tolerability of Palbociclib in Combination with Letrozole or Fulvestrant in Patients Aged 70 and Older with Estrogen Receptor-Positive, HER2-Negative Metastatic Breast Cancer
NCT#03633331
(Click for More Info)
Eligible for screening study DCP 001
ALLIANCE A211601
Primary Category:
Cancer Control and Prevention Protocols
Disease Category:
Adjuvant Breast, Breast
Evaluation of Mammographic Breast Density Effect of Aspirin: A Companion to Alliance Study A011502
NCT#03609021
(Click for More Info)
Eligible for screening study DCP 001
ALLIANCE A221405
Primary Category:
Cancer Control and Prevention Protocols, Treatment Protocols
Disease Category:
Adjuvant Breast, Breast
Pregnancy Outcome and Safety of Interrupting Therapy for women with endocrine responsIVE breast cancer
NCT#02308085
(Click for More Info)
Eligible for screening study DCP 001
This protocol has additional regulatory requirements to be completed prior to registering any patients at your site. Please contact Amber Boerner at 406-969-6067 or aboerner@mtcancer.org for additional information.
ALLIANCE A221505
Primary Category:
Radiation Oncology, Surgical Protocols
Disease Category:
Adjuvant Breast, Breast
Phase III Randomized Trial of Hypofractionated Post Mastectomy Radiation with Breast Reconstruction
NCT#03414970
(Click for More Info)
Eligible for screening study DCP 001
ALLIANCE A221701
Primary Category:
Cancer Control and Prevention Protocols
Disease Category:
Breast, Gastrointestinal, Genitourinary, Neuroendocrine, Pancreatic, Renal
Phase III Placebo-Controlled Trial to Evaluate Dexamethasone Use for Everolimus-Induced Oral Stomatitis: Prevention versus Early Treatment Approaches
NCT#03839940
(Click for More Info)
Eligible for screening study DCP 001
ALLIANCE A221702
Primary Category:
Surgical Protocols
Disease Category:
Adjuvant Breast, Breast
ARM: Axillary Reverse Mapping – A Prospective Trial to Study Rates of Lymphedema and Regional Recurrence After Sentinel Lymph Node Biopsy and Sentinel Lymph Node Biopsy Followed by Axillary Lymph Node Dissection With and Without Axillary Reverse Mapping
Eligible for screening study DCP 001
(Click for More Info)
ALLIANCE A231701CD
Primary Category:
Cancer Care Delivery, Surgical Protocols
Disease Category:
Breast, Cancer Care Delivery
Increasing Socioeconomically Disadvantaged Patients’ Engagement in Breast Cancer Surgery Decision Making Through a Shared Decision Making Intervention
NCT#03766009
(Click for More Info)
Limited institution study – Only open to: Billings Clinic
ALLIANCE Z11102
Primary Category:
Surgical Protocols
Impact of Breast Conservation Surgery on Surgical Outcomes and Cosmesis in Patients with Multiple Ipsilateral Breast Cancers (MIBC)
NCT#01556243
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ECOG-ACRIN E2108
Primary Category:
Treatment Protocols
Disease Category:
Breast, Breast Metastatic, Breast Neoadjuvant
A Randomized Phase III Trial of the Value of Early Local Therapy for the Intact Primary Tumor in Patients with Metastatic Breast Cancer
E2108 is approaching its accrual goal. Therefore, this study closed to accrual effective July 23, 2015 at 5:00 p.m. EDT for Step 1 registrations. Patients already registered to Step 1 may continue the process to Step 2 randomization, however no new Step 1 registrations will be permitted after this date.
NCT#01242800
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ECOG-ACRIN E5103
Primary Category:
Treatment Protocols
Disease Category:
Adjuvant Breast, Breast
A Double-Blind Phase III Trial of Doxorubicin and Cyclophosphamide followed by Paclitaxel with Bevacizumab or Placebo in Patients with Lymph Node Positive and High Risk Lymph Node Negative Breast Cancer
E5103 Step 3 registration, registration to the EL112LAB substudy, will close to accrual on July 29, 2016.
NCT#00433511
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ECOG-ACRIN EA1131
Primary Category:
Treatment Protocols
Disease Category:
Adjuvant Breast, Breast
A Randomized Phase III Post-Operative Trial of Platinum Based Chemotherapy Vs. Capecitabine in Patients with Residual Triple-Negative Breast Cancer following Neoadjuvant Chemotherapy
Eligible for screening study DCP 001
NCT#02445391
(Click for More Info)
ECOG-ACRIN EAQ152
Primary Category:
Cancer Control and Prevention Protocols
Disease Category:
Brain, Breast, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Lung, Lymphoma, Melanoma, Molecular Profiling, Other, Sarcoma
COMET – Communication and Education in Tumor Profiling: A Randomized Study of Pre-disclosure Genetic Education v. Usual Care in Tumor Profiling for Advanced Cancer and a Pilot Study of Remote Genetic Counseling for Participants with Potential Germline Mutations Identified on Tumor Profiling
(Sub-study for EAY131)
Eligible for screening study DCP 001
NCT#02823652
(Click for More Info)
MCC not eligible to participate in new addendum, as EAQ152 is only open to accrual at select sites.
ECOG-ACRIN EAY131
Primary Category:
Treatment Protocols
Disease Category:
Brain, Breast, Carcinoid, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Lung, Lymphoma, Melanoma, Molecular Profiling, Other, Sarcoma
Molecular Analysis for Therapy Choice (MATCH)
Eligible for screening study DCP 001
NCT#02465060
(Click for More Info)
The protocol allows designated private sector laboratories to refer patients to the study based on genetic testing performed independent of MATCH. This is limited to genetic testing ordered for patients at approved MATCH trial sites. Approved genetic testing laboratories and their date of inclusion in the outside assay process are:
- CARIS Life Sciences – 07/02/18
- CellNetix Pathology and Laboratories – 02/13/19
- Foundation Medicine – 07/02/18
- GenPath BioReference Laboratories – 08/03/18
- The Jackson Laboratory – 01/10/19
- NeoGenomics Laboratories – 07/02/18
- OmniSeq Laboratories – 07/16/18
- PathGroup – 10/29/18
- Quest Diagnostics Inc. – 05/20/19
- Strata Oncology – 08/03/18
- Tempus Laboratories – 07/16/18
The Biopsy consent form for this study is available upon request. Please contact Amber Boerner, aboerner@mtcancer.org or 406-969-6067, for the consent & for any questions.
(http://ecog-acrin.org/nci-match-eay131-designated-labs)
ECOG-ACRIN PACCT-1
Primary Category:
Treatment Protocols
Disease Category:
Adjuvant Breast, Breast
Program for the Assessment of Clinical Cancer Tests (PACCT-1): Trial Assigning Individualized Options for Treatment: The TAILORx Trial
Ancillary study EL112LAB for the PACCT1 Trial has reached its accrual goal. Therefore, PACCT1 Step 3 registration (EL112LAB) will be closed to accrual effective Friday, July 3, 2015 at 5:00 pm EST. (E5103 accrual remains open for EL112LAB.)
NCT#00310180
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NRG B-51
Primary Category:
Radiation Oncology, Treatment Protocols
Disease Category:
Breast, Breast Neoadjuvant
Randomized Phase III Clinical Trial Evaluating Post-Mastectomy Chestwall and Regional Nodal XRT and Post-Lumpectomy Regional Nodal XRT in Patients with Positive Axillary Nodes Before Neoadjuvant Chemotherapy Who Convert to Pathologically Negative Axillary Nodes After Neoadjuvant Chemotherapy
Eligible for screening study DCP 001
NCT#01872975
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The accrual goal for the Behaviorial and Health Outcomes (BAHO) Quality of Life component in the B-51 trial has been met. Therefore, effective August 6th, 2018, accrual will be closed to the QoL component. The B-51 trial remains open to accrual.
NRG B-52
Primary Category:
Treatment Protocols
Disease Category:
Breast, Breast Neoadjuvant
A Randomized Phase III Trial Evaluating Pathologic Complete Response Rates in Patients with Hormone Receptor-Positive, HER2-Positive, Large Operable and Locally Advanced Breast Cancer Treated with Neoadjuvant Therapy of Docetaxel, Carboplatin, Trastuzumab, and Pertuzumab (TCHP) With or Without Estrogen Deprivation
B-52 will close to accrual, today, February 29, 2016, effective 8 pm EST. We realize that some patients who have consented to participate in the study will not have completed their pre-entry biopsy to obtain fresh tumor samples by today; therefore, patients who have signed the B-52 consent form on or before today, February 29, 2016, will be permitted to enter the study.
NCT#02003209
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NRG B-55
Primary Category:
Treatment Protocols
Disease Category:
Adjuvant Breast, Breast, Breast Neoadjuvant
A Randomised, Double-Blind, Parallel Group, Placebo-Controlled Multi-Centre Phase III Study to Assess the Efficacy and Safety of Olaparib Versus Placebo as Adjuvant Treatment in Patients with Germline BRCA1/2 Mutations and High Risk HER2 Negative Primary Breast Cancer Who Have Completed Definitive Local Treatment and Neoadjuvant or Adjuvant Chemotherapy
Eligible for screening study DCP 001
NCT#02032823
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Closure of Part 1 and Part 2 Screening will occur on April 1, 2019 at 5:00 PM Eastern Time. Accrual to the NSABP B-55/BIG 6-13 trial will close on April 29, 2019 at 5:00 PM Eastern Time. Patients, who are in screening, must be randomized to the study by 5:00 PM on April 29, 2019.
NRG BR002
Primary Category:
Radiation Oncology, Treatment Protocols
Disease Category:
Breast, Breast Metastatic
Status:
Temporarily Closed
A Phase IIR/III Trial of Standard of Care Therapy with or without Stereotactic Body Radiotherapy (SBRT) and/or Surgical Ablation for Newly Oligometastatic Breast Cancer
Effective, Friday, September 13th, 2019, study NRG BR002 is temporarily closed to accrual at 3 p.m. MST.
NCT#02364557
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NRG BR003
Primary Category:
Treatment Protocols
Disease Category:
Adjuvant Breast, Breast
A Randomized Phase III Trial of Adjuvant Therapy Comparing Doxorubicin Plus Cyclophosphamide Followed by Weekly Paclitaxel with or without Carboplatin for Node Positive or High-Risk Node-Negative Triple-Negative Invasive Breast Cancer
Eligible for screening study DCP 001
NCT#02488967
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NRG BR004
Primary Category:
Treatment Protocols
Disease Category:
Breast, Breast Metastatic
A Randomized, Double-Blind, Phase III Trial of Paclitaxel/Trastuzumab/Pertuzumab with Atezolizumab or Placebo in First-Line HER2-Positive Metastatic Breast Cancer
NCT#03199885
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NRG BR005
Primary Category:
Treatment Protocols
Disease Category:
Breast, Breast Neoadjuvant
Status:
Temporarily Closed
A Phase II Trial Assessing the Accuracy of Tumor Bed Biopsies in Predicting Pathologic Response in Patients with Clinical/Radiologic Complete Response after Neoadjuvant Chemotherapy in Order to Explore the Feasibility of Breast Conserving Treatment without Surgery
NCT#03188393
Effective today, July 2, 2019, study NRG BR005 is temporarily closed to accrual.
(Click for More Info)
NRG CC004
Primary Category:
Cancer Control and Prevention Protocols
Disease Category:
Breast, Gynecologic
Phase II Double Blind Dose Finding Trial of Bupropion Versus Placebo for Sexual Desire in Women with Breast or Gynecologic Cancer
Eligible for screening study DCP 001
NCT#03180294
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This protocol has additional regulatory requirements to be completed prior to registering any patients at your site. Please contact Amber Boerner at 406-969-6067 or aboerner@mtcancer.org for additional information.
NRG CCTG MA.39
Primary Category:
Radiation Oncology, Treatment Protocols
Disease Category:
Adjuvant Breast, Breast
A Randomized Trial of Regional Radiotherapy in Biomarker Low Risk Node Positive Breast Cancer
For CCTG MA.39, please credit NRG all accruals.
NCT#03550391
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SWOG S1007
Primary Category:
Treatment Protocols
Disease Category:
Adjuvant Breast, Breast
A Phase III, Randomized Clinical Trial of Standard Adjuvant Endocrine Therapy +/- Chemotherapy in Patients with 1-3 Positive Nodes, Hormone Receptor-Positive and HER2-Negative Breast Cancer with Recurrence Score (RS) of 25 or Less. RxPONDER: A Clinical Trial Rx for Positive Node, Endocrine Responsive Breast Cancer
S1007 will be permanently closed to accrual for Step 1 registration effective October 1, 2015 at 11:59 p.m. PST. The study will be permanently closed to accrual for Step 2 registration effective October 15, 2015 at 11:59 p.m. PST. Patients who will be registered to Step 1 and Step 2 at the same time (patients whose Recurrence Score is already known) must be registered prior to closure of Step 1
registration on October 1, 2015.
NCT#01272037
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SWOG S1207
Primary Category:
Treatment Protocols
Disease Category:
Adjuvant Breast, Breast
Phase III Randomized, Placebo-Controlled Clinical Trial Evaluating the Use of Adjuvant Endocrine Therapy +/- One Year of Everolimus in Patients with High-Risk, Hormone Receptor-Positive and HER2/neu Negative Breast Cancer. e^3 Breast Cancer Study-Evaluating Everolimus with Endocrine Therapy
NCT#01674140
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Eligible for screening study DCP 001
SWOG S1416
Primary Category:
Treatment Protocols
Disease Category:
Breast, Breast Metastatic
Phase II Randomized Placebo-Controlled Trial of Cisplatin with or Without ABT-888 (Veliparib) in Metastatic Triple-Negative Breast Cancer and/or BRCA Mutation-Associated Breast Cancer
NCT#02595905
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Effective, today, June 15th, 2019, SWOG S1416, is permanently closed to accrual.
SWOG S1418
Primary Category:
Treatment Protocols
Disease Category:
Adjuvant Breast, Breast
A Randomized, Phase III Trial to Evaluate the Efficacy and Safety of MK-3475 as Adjuvant Therapy for Triple Receptor-Negative Breast Cancer with > 1 cm Residual Invasive Cancer or Positive Lymph Nodes (ypN+) After Neoadjuvant Chemotherapy
Eligible for screening study DCP 001
NCT#02954874
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Site Delegation of Tasks Log required prior to registration of any patients.
SWOG S1501
Primary Category:
Cancer Control and Prevention Protocols
Disease Category:
Breast, Breast Metastatic
Prospective Evaluation of Carvedilol in Prevention of Cardiac Toxicity in Patients with Metastatic HER-2+ Breast Cancer, Phase III
Eligible for screening study DCP 001
NCT#03418961
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SWOG S1614
Primary Category:
Cancer Control and Prevention Protocols
Disease Category:
Brain, Breast, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Lung, Neuroendocrine, Other, Sarcoma, Skin, Thyroid
A Phase III Randomized Trial of Prophylactic Antiviral Therapy in Patients with Current or Past Hepatitis B Virus (HBV) Infection Receiving Anti-Cancer Therapy for Solid Tumors
NCT#03887702
(Click for More Info)
SWOG S1703
Primary Category:
Cancer Control and Prevention Protocols
Disease Category:
Breast, Breast Metastatic
Randomized Non-Inferiority Trial Comparing Overall Survival of Patients Monitored with Serum Tumor Marker Directed Disease Monitoring (STMDDM) versus Usual Care in Patients with Metastatic Hormone Receptor Positive Breast Cancer
NCT#03723928
(Click for More Info)
Eligible for screening study DCP 001
SWOG S1706
Primary Category:
Radiation Oncology, Treatment Protocols
Disease Category:
Adjuvant Breast, Breast
A Phase II Randomized Trial of Olaparib (NSC-747856) Administered Concurrently with Radiotherapy Versus Radiotherapy Alone for Inflammatory Breast Cancer
NCT#03598257
(Click for More Info)
SWOG S1916
Primary Category:
Cancer Control and Prevention Protocols
Disease Category:
Brain, Breast, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Leukemia, Lung, Lymphoma, Multiple Myeloma, Neuroendocrine, Sarcoma, Skin, Thyroid
Status:
Upcoming - Pending IRB Review
Feasibility of a Digital Medicine Program in Optimizing Opioid Pain Control in Cancer Patients
Limited site participation. Open only to Billings Clinic.
Please see the SWOG website for any study documents not found here on the MCC website.
Cancer Care Delivery
ALLIANCE A231701CD
Primary Category:
Cancer Care Delivery, Surgical Protocols
Disease Category:
Breast, Cancer Care Delivery
Increasing Socioeconomically Disadvantaged Patients’ Engagement in Breast Cancer Surgery Decision Making Through a Shared Decision Making Intervention
NCT#03766009
(Click for More Info)
Limited institution study – Only open to: Billings Clinic
ECOG-ACRIN EAQ162CD
Primary Category:
Cancer Care Delivery, Cancer Control and Prevention Protocols
Disease Category:
Cancer Care Delivery, Colon, Gastrointestinal, Rectal
Longitudinal Assessment of Financial Burden in Patients with Colon or Rectal Cancer Treated with Curative Intent
NCT#03516942
(Click for More Info)
Eligible for screening study DCP 001
The “Colon Cancer, Receiving Chemotherapy” (or Colon/Chemo) cohort closed to accrual on May 2, 2019. The “Rectal Cancer, Receiving Chemotherapy” or (Rectal/Chemo) re-opened to accrual on August 26, 2019
ECOG-ACRIN EAQ171CD
Primary Category:
Cancer Care Delivery
Disease Category:
Cancer Care Delivery
Implementing a Virtual Tobacco Treatment in Community Oncology Practices: “Smoke Free Support Study 2.0”
NCT#03808818
(Click for More Info)
Contact Amanda Dinsdale at 406-969-6063 or adinsdale@mtcancer.org if your site is interested in participating in this study.
SWOG S1415CD
Primary Category:
Cancer Care Delivery, Cancer Control and Prevention Protocols
Disease Category:
Cancer Care Delivery
A Pragmatic Trial Evaluating a Colony Stimulating Factor Intervention in Standing Orders and the Effectiveness of Colony Stimulating Factor Use as Prophylaxis for Patients Receiving Chemotherapy with Intermediate Risk for Febrile Neutropenia
Limited site participation. Open only to Billings Clinic, Bozeman Health, and Saint Alphonsus
Effective December 2nd, 2019, study S1415CD will be permanently closed to low or high risk accruals. Intermediate risk accrual remains open for randomized sites.
NCT#02728596
(Click for More Info)
Eligible for screening study DCP 001
SWOG S1417CD
Primary Category:
Cancer Care Delivery, Cancer Control and Prevention Protocols
Disease Category:
Cancer Care Delivery, Colon, Colon Metastatic, Gastrointestinal, Rectal, Rectal Metastatic
Implementation of a Prospective Financial Impact Assessment Tool in Patients with Metastatic Colorectal Cancer
NCT#02728804
(Click for More Info)
Eligible for screening study DCP 001
S1417CD will be permanently closed to patient accrual, effective February 1, 2019 at 11:59 p.m. Pacific Standard Time.
WAKE WF-1803CD
Primary Category:
Cancer Care Delivery
Disease Category:
Cancer Care Delivery
Supportive Care Service Availability for Cancer Caregivers in Community Oncology Practices
NCT#03746314
(Click for More Info)
Contact Amanda Dinsdale at 406-969-6063 or adinsdale@mtcancer.org if your site is interested in participating in this study.
Gastrointestinal
AFT-28 CANVAS
Primary Category:
Cancer Control and Prevention Protocols
Disease Category:
Brain, Breast, Chronic Lymphocytic Leukemia, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Lung, Lymphoma, Melanoma, Multiple Myeloma, Neuroendocrine, Sarcoma
Direct Oral Anticoagulants (DOACs) versus LMWH +/- Warfarin for VTE in Cancer: A Randomized Effectiveness Trial (CANVAS Trial)
NCT#02744092
(Click for More Info)
Limited institution study – Only open to: Benefis Sletten Cancer Institute, Billings Clinic, Bozeman Health, Community Hospital of Anaconda, Community Medical Center, Kalispell Regional Medical Center, Kootenai Health, & Saint Alphonsus Regional Medical Center.
Sites must submit to MCC an AFT Delegation of Authority Log before any patient registrations may take place.
AFT-39 PROTECT
Primary Category:
Cancer Control and Prevention Protocols
Disease Category:
Anal, Bladder, Brain, Breast, Carcinoid, Cervical, Cholangiocarcinoma, Colon, Colon Metastatic, Endometrial, Esophageal, Gallbladder, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Liver, Lung, Lung - Non-Small Cell, Lung - Small Cell, Lymphoma, Melanoma, Multiple Myeloma, Neuroendocrine, Ovarian, Pancreatic, Prostate, Rectal, Renal, Sarcoma, Stomach, Thyroid, Uterine
Electronic patient reporting of symptoms during outpatient cancer treatment: A U.S. national randomized controlled trial (the “PRO-TECT” trial)
NCT#03249090
(Click for More Info)
Limited institution study – Only open to: Billings Clinic & Bozeman Health
Effective, October 25th, 2019, the CONTROL arm of AFT 39, is closed to accrual.
ALLIANCE A021502
Primary Category:
Treatment Protocols
Disease Category:
Colon, Gastrointestinal
Randomized Trial of Standard Chemotherapy Alone or Combined with Atezolizumab as Adjuvant Therapy for Patients with Stage III Colon Cancer and Deficient DNA Mismatch Repair
Eligible for screening study DCP 001
NCT#02912559
(Click for More Info)
Site Delegation of Tasks Log required prior to registration of any patients.
ALLIANCE A021602
Primary Category:
Treatment Protocols
Disease Category:
Carcinoid, Neuroendocrine, Pancreatic
Randomized, Double-Blinded Phase III Study of CABozantinib Versus Placebo IN Patients with Advanced NEuroendocrine Tumors After Progression on Everolimus (CABINET)
NCT#03375320
(Click for More Info)
Eligible for screening study DCP 001
ALLIANCE A021703
Primary Category:
Treatment Protocols
Disease Category:
Colon, Colon Metastatic, Gastrointestinal, Rectal, Rectal Metastatic
Randomized Double-Blind Phase III Trial of Vitamin D3 Supplementation in Patients with Previously Untreated Metastatic Colorectal Cancer (SOLARIS)
Eligible for screening study DCP 001
NCT#04094688
(Click for More Info)
ALLIANCE A221701
Primary Category:
Cancer Control and Prevention Protocols
Disease Category:
Breast, Gastrointestinal, Genitourinary, Neuroendocrine, Pancreatic, Renal
Phase III Placebo-Controlled Trial to Evaluate Dexamethasone Use for Everolimus-Induced Oral Stomatitis: Prevention versus Early Treatment Approaches
NCT#03839940
(Click for More Info)
Eligible for screening study DCP 001
ALLIANCE C80702
Primary Category:
Treatment Protocols
Disease Category:
Colon, Gastrointestinal
A Phase III Trial of 6 versus 12 Treatments of Adjuvant FOLFOX Plus Celecoxib or Placebo for Patients With Resected Stage III Colon Cancer
CALGB/SWOG 80702 is nearing its accrual goal. Therefore, effective Friday, November 20th, 2015 at 4:30 PM ET, CALGB/SWOG 80702 will permanently close to new patient accrual.
NCT#01150045
(Click for More Info)
ALLIANCE C80803
Primary Category:
Radiation Oncology, Treatment Protocols
Disease Category:
Esophageal, Gastrointestinal
Randomized Phase II Trial of PET Scan-Directed Combined Modality Therapy in Esophageal Cancer
CALGB 80803 has met its accrual goal. Therefore, effective Monday, May 11, 2015 at 4:30 PM (ET), CALGB 80803 will permanently close to new patient accrual.
NCT#01333033
(Click for More Info)
ALLIANCE N1048
Primary Category:
Radiation Oncology, Treatment Protocols
Disease Category:
Gastrointestinal, Rectal
A Phase II/III Trial of Neoadjuvant FOLFOX with Selective Use of Combined Modality Chemoradiation versus Preoperative Combined Modality Chemoradiation for Locally Advanced Rectal Cancer Patients Undergoing Low Anterior Resection with Total Mesorectal Excision (PROSPECT)
Eligible for screening study DCP 001
NCT#01515787
(Click for More Info)
N1048 will soon meet its accrual goal, and therefore, EFFECTIVE Friday, December 28, 2018 at 4:30 PM ET, will permanently close to new patient accrual.
ECOG-ACRIN EA2142
Primary Category:
Treatment Protocols
Disease Category:
Gastrointestinal, Neuroendocrine
Randomized Phase II Study of Cisplatin and Etoposide versus Temozolomide and Capecitabine in Patients with Advanced G3 Non-Small Cell Gastroenteropancreatic Neuroendocrine Carcinomas
NCT#02595424
(Click for More Info)
ECOG-ACRIN EA2161
Primary Category:
Treatment Protocols
Disease Category:
Carcinoid, Gastrointestinal, Neuroendocrine, Pancreatic
Status:
Temporarily Closed
A Phase II Study of MLN0128 (TAK-228) in Rapalog-Resistant Advanced Pancreatic Neuroendocrine Tumors (PNET)
Due to completion of accrual to the first stage, accrual to EA2161 is temporarily suspended effective 11/5/18. Only patients who have signed a consent to participate on or before 3:00 PM MST November 5, 2018 will be accepted. Consented patients must be registered on or before 3:00 PM MST November 12, 2018.
NCT#02893930
(Click for More Info)
ECOG-ACRIN EA2165
Primary Category:
Radiation Oncology, Treatment Protocols
Disease Category:
Anal, Gastrointestinal
A Randomized Phase II Study of Nivolumab After Combined Modality Therapy (CMT) in High Risk Anal Cancer
NCT#03233711
(Click for More Info)
ECOG-ACRIN EAQ152
Primary Category:
Cancer Control and Prevention Protocols
Disease Category:
Brain, Breast, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Lung, Lymphoma, Melanoma, Molecular Profiling, Other, Sarcoma
COMET – Communication and Education in Tumor Profiling: A Randomized Study of Pre-disclosure Genetic Education v. Usual Care in Tumor Profiling for Advanced Cancer and a Pilot Study of Remote Genetic Counseling for Participants with Potential Germline Mutations Identified on Tumor Profiling
(Sub-study for EAY131)
Eligible for screening study DCP 001
NCT#02823652
(Click for More Info)
MCC not eligible to participate in new addendum, as EAQ152 is only open to accrual at select sites.
ECOG-ACRIN EAQ162CD
Primary Category:
Cancer Care Delivery, Cancer Control and Prevention Protocols
Disease Category:
Cancer Care Delivery, Colon, Gastrointestinal, Rectal
Longitudinal Assessment of Financial Burden in Patients with Colon or Rectal Cancer Treated with Curative Intent
NCT#03516942
(Click for More Info)
Eligible for screening study DCP 001
The “Colon Cancer, Receiving Chemotherapy” (or Colon/Chemo) cohort closed to accrual on May 2, 2019. The “Rectal Cancer, Receiving Chemotherapy” or (Rectal/Chemo) re-opened to accrual on August 26, 2019
ECOG-ACRIN EAY131
Primary Category:
Treatment Protocols
Disease Category:
Brain, Breast, Carcinoid, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Lung, Lymphoma, Melanoma, Molecular Profiling, Other, Sarcoma
Molecular Analysis for Therapy Choice (MATCH)
Eligible for screening study DCP 001
NCT#02465060
(Click for More Info)
The protocol allows designated private sector laboratories to refer patients to the study based on genetic testing performed independent of MATCH. This is limited to genetic testing ordered for patients at approved MATCH trial sites. Approved genetic testing laboratories and their date of inclusion in the outside assay process are:
- CARIS Life Sciences – 07/02/18
- CellNetix Pathology and Laboratories – 02/13/19
- Foundation Medicine – 07/02/18
- GenPath BioReference Laboratories – 08/03/18
- The Jackson Laboratory – 01/10/19
- NeoGenomics Laboratories – 07/02/18
- OmniSeq Laboratories – 07/16/18
- PathGroup – 10/29/18
- Quest Diagnostics Inc. – 05/20/19
- Strata Oncology – 08/03/18
- Tempus Laboratories – 07/16/18
The Biopsy consent form for this study is available upon request. Please contact Amber Boerner, aboerner@mtcancer.org or 406-969-6067, for the consent & for any questions.
(http://ecog-acrin.org/nci-match-eay131-designated-labs)
NRG GI002
Primary Category:
Radiation Oncology, Treatment Protocols
Disease Category:
Gastrointestinal, Rectal
Status:
Temporarily Closed
A Phase II Clinical Trial Platform of Sensitization Utilizing Total Neoadjuvant Therapy (TNT) in Rectal Cancer
NCT#02921256
(Click for More Info)
As of February 12, 2018 Arm 2 is permanently closed having met its enrollment goal.
The NRG-GI002 study serves as a platform to test novel agents in the neoadjuvant treatment of rectal cancer. It is projected that enrollment to the ARM1 (control) vs. ARM 3 (MK-3475/pembrolizumab) comparison could meet the accrual goal of 178 patients as early as May 13, 2019. The pembrolizumab comparison will complete enrollment before activation of another experimental arm. This will result in a temporary suspension of accrual to the entire NRG-GI002 trial.
As of Tuesday, May 14th, 2019 at 9:00 am EST, NRG-GI002 (Arm 1 and 3) has met its accrual goal and is temporarily suspended.
NRG GI004
Primary Category:
Treatment Protocols
Disease Category:
Colon, Colon Metastatic, Gastrointestinal, Rectal, Rectal Metastatic
Colorectal Cancer Metastatic dMMR Immuno-Therapy (COMMIT) Study: A Randomized Phase III Study of mFOLFOX6/Bevacizumab Combination Chemotherapy with or without Atezolizumab or Atezolizumab Monotherapy in the First-Line Treatment of Patients with Deficient DNA Mismatch Repair (dMMR) Metastatic Colorectal Cancer
Eligible for screening study DCP 001
NCT#02997228
(Click for More Info)
Site Delegation of Tasks Log required prior to registration of any patients.
NRG R0848
Primary Category:
Radiation Oncology, Treatment Protocols
Disease Category:
Gastrointestinal, Pancreatic
A Phase II-R and A Phase III Trial Evaluating Both Erlotinib (Ph II-R) and Chemoradiation (Ph III) as Adjuvant Treatment for Patients with Resected Head of Pancreas Adenocarcinoma
NCT#01013649
(Click for More Info)
Eligible for screening study DCP 001
R0848 will close to accrual at 5 PM ET Friday, June 1, 2018, because it has reached its accrual target. Step 2 randomization will remain open. All patients registered to Step 1 by Friday, June 1, 2018 will proceed to the randomization step (Step 2). If patients are unable to be randomized, Step 2 will still be completed with the reason for no randomization being provided.
NRG R1010
Primary Category:
Radiation Oncology, Treatment Protocols
Disease Category:
Esophageal, Gastrointestinal
A Phase III Trial Evaluating the Addition of Trastuzumab to Trimodality Treatment of HER2-Overexpressing Esophageal Adenocarcinoma
R1010 will close to STEP 1 registration at 5 PM EST on Tuesday, November 10, 2015, because the study has reached its accrual target. STEP 2 registration will remain open and all eligible patients determined to be HER2 positive will be permitted to be randomized for treatment on this trial.
NCT#01196390
(Click for More Info)
NRG R1201
Primary Category:
Radiation Oncology, Treatment Protocols
Disease Category:
Gastrointestinal, Pancreatic
A Phase II Randomized Trial Evaluating the Addition of High or Standard Intensity Radiation to Gemcitabine and Nab-Paclitaxel for Locally Advanced Pancreatic Cancer
R1201 is permanently closed to accrual, effective immediately, June 30, 2016. After an accrual assessment by CTEP it was determined that the trial would not be completed within a reasonable timeframe per CTEP’s Early Phase Trial Slow Accrual guidelines. Please note there are no increased safety risks that led to this decision of closure. Study-specific follow-up and data submission will cease for all patients.
NCT#01921751
(Click for More Info)
SWOG S1417CD
Primary Category:
Cancer Care Delivery, Cancer Control and Prevention Protocols
Disease Category:
Cancer Care Delivery, Colon, Colon Metastatic, Gastrointestinal, Rectal, Rectal Metastatic
Implementation of a Prospective Financial Impact Assessment Tool in Patients with Metastatic Colorectal Cancer
NCT#02728804
(Click for More Info)
Eligible for screening study DCP 001
S1417CD will be permanently closed to patient accrual, effective February 1, 2019 at 11:59 p.m. Pacific Standard Time.
SWOG S1513
Primary Category:
Treatment Protocols
Disease Category:
Gastrointestinal, Pancreatic, Pancreatic Metastatic
Randomized Phase II Study of 2nd Line FOLFIRI versus Modified FOLFIRI with PARP Inhibitor ABT-888 (Veliparib) (NSC-737664) in Metastatic Pancreatic Cancer
NCT#02890355
(Click for More Info)
S1513 is permanently closed to accrual effective immediately. 12/13/17. At a planned interim analysis, our Data and Safety Monitoring Committee recommended that S1513 be closed permanently based on the results. These results will be shared, and further instructions given in a forthcoming letter to patients and investigators. Patients currently receiving ABT-888 (Veliparib) must discontinue the experimental treatment but may continue on FOLFIRI alone. Patients on both arms should continue study follow-up.
SWOG S1613
Primary Category:
Treatment Protocols
Disease Category:
Colon, Colon Metastatic, Gastrointestinal, Rectal, Rectal Metastatic
A Randomized Phase II Study of Trastuzumab and Pertuzumab (TP) Compared to Cetuximab and Irinotecan (CETIRI) in Advanced/Metastatic Colorectal Cancer (MCRC) with HER-2 Amplification
NCT#03365882
(Click for More Info)
SWOG S1614
Primary Category:
Cancer Control and Prevention Protocols
Disease Category:
Brain, Breast, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Lung, Neuroendocrine, Other, Sarcoma, Skin, Thyroid
A Phase III Randomized Trial of Prophylactic Antiviral Therapy in Patients with Current or Past Hepatitis B Virus (HBV) Infection Receiving Anti-Cancer Therapy for Solid Tumors
NCT#03887702
(Click for More Info)
SWOG S1815
Primary Category:
Treatment Protocols
Disease Category:
Cholangiocarcinoma, Gallbladder, Gastrointestinal
A Phase III Randomized Trial of Gemcitabine, Cisplatin, and Nab-Paclitaxel Versus Gemcitabine and Cisplatin in Newly Diagnosed, Advanced Biliary Tract Cancers
Eligible for screening study DCP 001
NCT#03768414
(Click for More Info)
SWOG S1916
Primary Category:
Cancer Control and Prevention Protocols
Disease Category:
Brain, Breast, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Leukemia, Lung, Lymphoma, Multiple Myeloma, Neuroendocrine, Sarcoma, Skin, Thyroid
Status:
Upcoming - Pending IRB Review
Feasibility of a Digital Medicine Program in Optimizing Opioid Pain Control in Cancer Patients
Limited site participation. Open only to Billings Clinic.
Please see the SWOG website for any study documents not found here on the MCC website.
Genitourinary
AFT-28 CANVAS
Primary Category:
Cancer Control and Prevention Protocols
Disease Category:
Brain, Breast, Chronic Lymphocytic Leukemia, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Lung, Lymphoma, Melanoma, Multiple Myeloma, Neuroendocrine, Sarcoma
Direct Oral Anticoagulants (DOACs) versus LMWH +/- Warfarin for VTE in Cancer: A Randomized Effectiveness Trial (CANVAS Trial)
NCT#02744092
(Click for More Info)
Limited institution study – Only open to: Benefis Sletten Cancer Institute, Billings Clinic, Bozeman Health, Community Hospital of Anaconda, Community Medical Center, Kalispell Regional Medical Center, Kootenai Health, & Saint Alphonsus Regional Medical Center.
Sites must submit to MCC an AFT Delegation of Authority Log before any patient registrations may take place.
AFT-39 PROTECT
Primary Category:
Cancer Control and Prevention Protocols
Disease Category:
Anal, Bladder, Brain, Breast, Carcinoid, Cervical, Cholangiocarcinoma, Colon, Colon Metastatic, Endometrial, Esophageal, Gallbladder, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Liver, Lung, Lung - Non-Small Cell, Lung - Small Cell, Lymphoma, Melanoma, Multiple Myeloma, Neuroendocrine, Ovarian, Pancreatic, Prostate, Rectal, Renal, Sarcoma, Stomach, Thyroid, Uterine
Electronic patient reporting of symptoms during outpatient cancer treatment: A U.S. national randomized controlled trial (the “PRO-TECT” trial)
NCT#03249090
(Click for More Info)
Limited institution study – Only open to: Billings Clinic & Bozeman Health
Effective, October 25th, 2019, the CONTROL arm of AFT 39, is closed to accrual.
ALLIANCE A031102
Primary Category:
Treatment Protocols
Disease Category:
Genitourinary
A Randomized Phase III Trial Comparing Conventional-Dose Chemotherapy Using Paclitaxel, Ifosfamide, and Cisplatin (TIP) with High-Dose Chemotherapy Using Mobilizing Paclitaxel Plus Ifosfamide Followed by High-Dose Carboplatin and Etoposide (TI-CE) as First Salvage Treatment in Relapsed or Refractory Germ Cell Tumors
Eligible for screening study DCP 001
NCT#02375204
(Click for More Info)
ALLIANCE A031201
Primary Category:
Treatment Protocols
Disease Category:
Genitourinary, Prostate, Prostate Metastatic
Phase III Trial of Enzalutamide (NSC #766085) versus Enzalutamide, Abiraterone and Prednisone for Castration Resistant Metastatic Prostate Cancer
A031201 will soon meet its accrual goal. Therefore, effective August 31, 2016 at 4:30 PM ET, A031201 will be permanently closed to new patient accrual.
NCT#01949337
(Click for More Info)
ALLIANCE A031203
Primary Category:
Treatment Protocols
Disease Category:
Genitourinary, Renal, Renal Metastatic
Randomized Phase II Study Comparing Cabozantinib (NSC #761968 and IND #116059) with Commercially Supplied Sunitinib in Patients with Previously Untreated Locally Advanced or Metastatic Renal Cell Carcinoma
Effective Monday, April 6th, 2015 at 4:30 PM (ET), Alliance A031203 permanently closed to new patient accrual.
NCT#01835158
(Click for More Info)
ALLIANCE A031501
Primary Category:
Treatment Protocols
Disease Category:
Bladder, Genitourinary
Phase III Randomized Adjuvant study of MK-3475 (Pembrolizumab) in muScle invaSive and locAlly aDvanced urOthelial caRcinoma (AMBASSADOR) Versus Observation
NCT#03244384
(Click for More Info)
Eligible for screening study DCP 001
ALLIANCE A031701
Primary Category:
Treatment Protocols
Disease Category:
Bladder, Genitourinary
A Phase II Study of Dose-Dense Gemcitabine Plus Cisplatin (ddGC) in Patients with Muscle-Invasive Bladder Cancer with Bladder Preservation for Those Patients Whose Tumors Harbor Deleterious DNA Damage Response (DDR) Gene Alterations
NCT#03609216
(Click for More Info)
ALLIANCE A031702
Primary Category:
Treatment Protocols
Disease Category:
Bladder, Genitourinary, Prostate, Renal
Phase II Study of Cabozantinib in Combination with Nivolumab and Ipilimumab in Rare Genitourinary Tumors
(Click for More Info)
NCT#03866382
ALLIANCE A031704
Primary Category:
Treatment Protocols
Disease Category:
Genitourinary, Renal, Renal Metastatic
PD-Inhibitor (Nivolumab) and Ipilimumab Followed by Nivolumab Vs. VEGF TKI Cabozantinib with Nivolumab: A Phase III Trial in Metastatic Untreated REnal Cell CancEr [PDIGREE]
(Click for More Info)
Eligible for screening study DCP 001
NCT#03793166
ALLIANCE A221701
Primary Category:
Cancer Control and Prevention Protocols
Disease Category:
Breast, Gastrointestinal, Genitourinary, Neuroendocrine, Pancreatic, Renal
Phase III Placebo-Controlled Trial to Evaluate Dexamethasone Use for Everolimus-Induced Oral Stomatitis: Prevention versus Early Treatment Approaches
NCT#03839940
(Click for More Info)
Eligible for screening study DCP 001
ALLIANCE C70807
Primary Category:
Cancer Control and Prevention Protocols
Disease Category:
Genitourinary, Prostate
The Men’s Eating and Living (MEAL)Study: A Randomized Trial of Diet to Alter Disease Progression in Prostate Cancer Patients on Active Surveillance
CALGB 70807 has enrolled sufficient patients to the pre-registration step of the study to meet the registration/randomization accrual goal. Therefore, effective Friday, August 14, 2015 at 5:00 PM ET, CALGB 70807 will be permanently closed to new patient pre-registrations.
NCT#01238172
(Click for More Info)
ALLIANCE C90203
Primary Category:
Treatment Protocols
Disease Category:
Genitourinary, Prostate
A Randomized Phase III Study of Neoadjuvant Docetaxel and Androgen Deprivation Prior to Radical Prostatectomy versus Immediate Radical Prostatectomy in Patients with High-Risk, Clinically Localized Prostate Cancer
CALGB 90203 has met its accrual goal. Therefore, effective Friday, October 2nd, 2015 at 4:30 PM EST, CALGB 90203 will permanently close to new patient accrual.
NCT#00430183
(Click for More Info)
ECOG-ACRIN EA8143
Primary Category:
Treatment Protocols
Disease Category:
Genitourinary, Renal
A Phase 3 RandOmized Study Comparing PERioperative Nivolumab vs. Observation in Patients with Localized Renal Cell Carcinoma Undergoing Nephrectomy (PROSPER RCC)
Eligible for screening study DCP 001
NCT#03055013
(Click for More Info)
Site Delegation of Tasks Log required prior to registration of any patients.
ECOG-ACRIN EA8153
Primary Category:
Treatment Protocols
Disease Category:
Genitourinary, Prostate, Prostate Metastatic
Cabazitaxel with Abiraterone Versus Abiraterone Alone Randomized Trial for Extensive Disease Following Docetaxel: The CHAARTED2 Trial
NCT#03419234
(Click for More Info)
ECOG-ACRIN EA8171
Primary Category:
Treatment Protocols
Disease Category:
Genitourinary, Prostate
Multiparametric MRI (mpMRI) for Preoperative Staging and Treatment Planning for Newly-Diagnosed Prostate Cancer
NCT#03697148
(Click for More Info)
ECOG-ACRIN EAQ152
Primary Category:
Cancer Control and Prevention Protocols
Disease Category:
Brain, Breast, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Lung, Lymphoma, Melanoma, Molecular Profiling, Other, Sarcoma
COMET – Communication and Education in Tumor Profiling: A Randomized Study of Pre-disclosure Genetic Education v. Usual Care in Tumor Profiling for Advanced Cancer and a Pilot Study of Remote Genetic Counseling for Participants with Potential Germline Mutations Identified on Tumor Profiling
(Sub-study for EAY131)
Eligible for screening study DCP 001
NCT#02823652
(Click for More Info)
MCC not eligible to participate in new addendum, as EAQ152 is only open to accrual at select sites.
ECOG-ACRIN EAY131
Primary Category:
Treatment Protocols
Disease Category:
Brain, Breast, Carcinoid, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Lung, Lymphoma, Melanoma, Molecular Profiling, Other, Sarcoma
Molecular Analysis for Therapy Choice (MATCH)
Eligible for screening study DCP 001
NCT#02465060
(Click for More Info)
The protocol allows designated private sector laboratories to refer patients to the study based on genetic testing performed independent of MATCH. This is limited to genetic testing ordered for patients at approved MATCH trial sites. Approved genetic testing laboratories and their date of inclusion in the outside assay process are:
- CARIS Life Sciences – 07/02/18
- CellNetix Pathology and Laboratories – 02/13/19
- Foundation Medicine – 07/02/18
- GenPath BioReference Laboratories – 08/03/18
- The Jackson Laboratory – 01/10/19
- NeoGenomics Laboratories – 07/02/18
- OmniSeq Laboratories – 07/16/18
- PathGroup – 10/29/18
- Quest Diagnostics Inc. – 05/20/19
- Strata Oncology – 08/03/18
- Tempus Laboratories – 07/16/18
The Biopsy consent form for this study is available upon request. Please contact Amber Boerner, aboerner@mtcancer.org or 406-969-6067, for the consent & for any questions.
(http://ecog-acrin.org/nci-match-eay131-designated-labs)
NRG GU002
Primary Category:
Radiation Oncology, Treatment Protocols
Disease Category:
Genitourinary, Prostate
Phase II-III Trial of Adjuvant Radiotherapy and Androgen Deprivation Following Radical Prostatectomy With or Without Adjuvant Docetaxel
NCT#03070886
(Click for More Info)
NRG GU003
Primary Category:
Radiation Oncology, Treatment Protocols
Disease Category:
Genitourinary, Prostate
A Randomized Phase III Trial of Hypofractionated Post-Prostatectomy Radiation Therapy (HYPORT) versus Conventional Post-Prostatectomy Radiation Therapy (COPORT)
Eligible for screening study DCP 001
NCT#03274687
(Click for More Info)
GU003 will close to accrual at 5 PM ET Monday, July 9, 2018, because it has reached its accrual target. All patients registered to Step 1 registration by Monday, July 9, 2018 will be permitted to proceed to the randomization step (Step 2).
NRG GU005
Primary Category:
Radiation Oncology
Disease Category:
Genitourinary, Prostate
Phase III IGRT and SBRT Vs IGRT and Hypofractionated IMRT for Localized Intermediate Risk Prostate Cancer
Eligible for screening study DCP 001
NCT#03367702
(Click for More Info)
*RT Credentialing Required
**Because the AJCC staging version 8 was not ready for the study activation, AJCC staging version 7 must be used.
NRG GU006
Primary Category:
Radiation Oncology, Treatment Protocols
Disease Category:
Genitourinary, Prostate, Prostate Recurrent
A Phase II, Double-Blinded, Placebo-Controlled Randomized Trial of Salvage Radiotherapy with or Without Enhanced Anti-Androgen Therapy with Apalutamide in Recurrent Prostate Cancer
NCT#03371719
(Click for More Info)
NRG GU007
Primary Category:
Radiation Oncology
Disease Category:
Genitourinary, Prostate
Randomized Phase II Trial of Niraparib With Standard Combination Radiotherapy and Androgen Deprivation Therapy (ADT) in High Risk Prostate Cancer (With Initial Phase I)
(Click for More Info)
NRG R0521
Primary Category:
Radiation Oncology, Treatment Protocols
Disease Category:
Genitourinary, Prostate
A Phase III Protocol of Androgen Suppression (AS) and 3DCRT/IMRT vs AS and 3DCRT/IMRT Followed by Chemotherapy with Docetaxel and Prednisone for Localized, High-Risk Prostate Cancer
NCT#00288080
(Click for More Info)
NRG R0534
Primary Category:
Radiation Oncology, Treatment Protocols
Disease Category:
Genitourinary, Prostate, Prostate Recurrent
A Phase III Trial of Short Term Androgen Deprivation with Pelvic Lymph Node or Prostate Bed Only Radiotherapy (SPPORT) in Prostate Cancer Patients with a Rising PSA After Radical Prostatectomy
NCT#00567580
(Click for More Info)
R0534 will close to accrual at 5 PM EST Monday, March 30, 2015, because it is anticipated to have reached its accrual target by that time.
NRG R0815
Primary Category:
Radiation Oncology, Treatment Protocols
Disease Category:
Genitourinary, Prostate
A Phase III Prospective Randomized Trial of Dose-Escalated Radiotherapy with or without Short-Term Androgen Deprivation Therapy for Patients with Intermediate-Risk Prostate Cancer
R0815 will close to accrual at 5 PM EST on Monday, March 7, 2016, because the study has reached its accrual target.
NCT#00936390
(Click for More Info)
NRG R0924
Primary Category:
Radiation Oncology, Treatment Protocols
Disease Category:
Genitourinary, Prostate
Androgen Deprivation Therapy and High Dose Radiotherapy with or Without Whole-Pelvic Radiotherapy in Unfavorable Intermediate or Favorable High Risk Prostate Cancer: A Phase III Randomized Trial
Effective today, June 24th, 2019, study RTOG 0924 has reached its accrual goal and is now closed.
(QOL Sub-study is closed as its accrual goal has been met.)
Eligible for screening study DCP 001
NCT#01368588
(Click for More Info)
SWOG S0931
Primary Category:
Treatment Protocols
Disease Category:
Genitourinary, Renal
EVEREST: EVErolimus for Renal Cancer Ensuing Surgical Therapy, A Phase III Study
S0931 has met its accrual goal and will permanently close to accrual effective September 15, 2016 at 11:59 p.m. Pacific Time.
NCT#01120249
(Click for More Info)
SWOG S1216
Primary Category:
Treatment Protocols
Disease Category:
Genitourinary, Prostate, Prostate Metastatic
A Phase III Randomized Trial Comparing Androgen Deprivation Therapy + TAK-700 with Androgen Deprivation Therapy + Bicalutamide in Patients with Newly Diagnosed Metastatic Hormone Sensitive Prostate Cancer
NCT#01809691
(Click for More Info)
S1216 has met its accrual goal and will permanently close to accrual effective July 15, 2017 at 11:59 p.m. Pacific.
SWOG S1314
Primary Category:
Treatment Protocols
Disease Category:
Bladder, Genitourinary
A Randomized Phase II Study of CO-eXpression ExtrapolatioN (COXEN) with Neoadjuvant Chemotherapy for Localized, Muscle-Invasive Bladder Cancer
NCT#02177695
(Click for More Info)
S1314 has met its accrual goal and will permanently close to accrual effective December 1, 2017 at 11:59 p.m. Pacific.
SWOG S1500
Primary Category:
Treatment Protocols
Disease Category:
Renal, Renal Metastatic
A Randomized, Phase II Efficacy Assessment of Multiple MET Kinase Inhibitors (Cabozantinib [NSC #761968], Crizotinib [NSC #749005], Savolitinib [NSC #785348], and Sunitinib [NSC #736511]) in Metastatic Papillary Renal Carcinoma (PAPMET)
NCT#02761057
(Click for More Info)
Partial permanent closure for Arm 3 and Arm 4 effective 12/05/18.
SWOG S1602
Primary Category:
Treatment Protocols
Disease Category:
Bladder, Genitourinary
Status:
Temporarily Closed
A Phase III Randomized Trial to Evaluate the Influence of BCG Strain Differences and T Cell Priming with Intradermal BCG Before Intravesical Therapy for BCG-Naïve High-Grade Non-Muscle Invasive Bladder Cancer
NCT#03091660
(Click for More Info)
Eligible for screening study DCP 001
S1602 is temporarily closed to accrual, effective immediately, 08/28/19. Because the study has not been revised to outline the change in the randomization scheme, it is not ethical to continue patient randomization, due to the drug supply issue for BCG Tokyo-172.
SWOG S1605
Primary Category:
Treatment Protocols
Disease Category:
Bladder, Genitourinary
Phase II Trial of Atezolizumab in BCG-Unresponsive Non-Muscle Invasive Bladder Cancer
Effective, July 5, 2019, study S1605 is permanently closed to accrual.
NCT#02844816
(Click for More Info)
SWOG S1614
Primary Category:
Cancer Control and Prevention Protocols
Disease Category:
Brain, Breast, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Lung, Neuroendocrine, Other, Sarcoma, Skin, Thyroid
A Phase III Randomized Trial of Prophylactic Antiviral Therapy in Patients with Current or Past Hepatitis B Virus (HBV) Infection Receiving Anti-Cancer Therapy for Solid Tumors
NCT#03887702
(Click for More Info)
SWOG S1802
Primary Category:
Radiation Oncology, Surgical Protocols, Treatment Protocols
Disease Category:
Genitourinary, Prostate, Prostate Metastatic
Phase III Randomized Trial of Standard Systemic Therapy (SST) Versus Standard Systemic Therapy Plus Definitive Treatment (Surgery or Radiation) of the Primary Tumor in Metastatic Prostate Cancer
NCT#03678025
(Click for More Info)
Eligible for screening study DCP 001
SWOG S1806
Primary Category:
Radiation Oncology, Treatment Protocols
Disease Category:
Bladder, Genitourinary
Phase III Randomized Trial of Concurrent Chemoradiotherapy with or Without Atezolizumab in Localized Muscle Invasive Bladder Cancer
(Click for More Info)
NCT#03775265
SWOG S1916
Primary Category:
Cancer Control and Prevention Protocols
Disease Category:
Brain, Breast, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Leukemia, Lung, Lymphoma, Multiple Myeloma, Neuroendocrine, Sarcoma, Skin, Thyroid
Status:
Upcoming - Pending IRB Review
Feasibility of a Digital Medicine Program in Optimizing Opioid Pain Control in Cancer Patients
Limited site participation. Open only to Billings Clinic.
Please see the SWOG website for any study documents not found here on the MCC website.
Gynecologic
AFT-28 CANVAS
Primary Category:
Cancer Control and Prevention Protocols
Disease Category:
Brain, Breast, Chronic Lymphocytic Leukemia, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Lung, Lymphoma, Melanoma, Multiple Myeloma, Neuroendocrine, Sarcoma
Direct Oral Anticoagulants (DOACs) versus LMWH +/- Warfarin for VTE in Cancer: A Randomized Effectiveness Trial (CANVAS Trial)
NCT#02744092
(Click for More Info)
Limited institution study – Only open to: Benefis Sletten Cancer Institute, Billings Clinic, Bozeman Health, Community Hospital of Anaconda, Community Medical Center, Kalispell Regional Medical Center, Kootenai Health, & Saint Alphonsus Regional Medical Center.
Sites must submit to MCC an AFT Delegation of Authority Log before any patient registrations may take place.
AFT-39 PROTECT
Primary Category:
Cancer Control and Prevention Protocols
Disease Category:
Anal, Bladder, Brain, Breast, Carcinoid, Cervical, Cholangiocarcinoma, Colon, Colon Metastatic, Endometrial, Esophageal, Gallbladder, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Liver, Lung, Lung - Non-Small Cell, Lung - Small Cell, Lymphoma, Melanoma, Multiple Myeloma, Neuroendocrine, Ovarian, Pancreatic, Prostate, Rectal, Renal, Sarcoma, Stomach, Thyroid, Uterine
Electronic patient reporting of symptoms during outpatient cancer treatment: A U.S. national randomized controlled trial (the “PRO-TECT” trial)
NCT#03249090
(Click for More Info)
Limited institution study – Only open to: Billings Clinic & Bozeman Health
Effective, October 25th, 2019, the CONTROL arm of AFT 39, is closed to accrual.
ECOG-ACRIN EAQ152
Primary Category:
Cancer Control and Prevention Protocols
Disease Category:
Brain, Breast, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Lung, Lymphoma, Melanoma, Molecular Profiling, Other, Sarcoma
COMET – Communication and Education in Tumor Profiling: A Randomized Study of Pre-disclosure Genetic Education v. Usual Care in Tumor Profiling for Advanced Cancer and a Pilot Study of Remote Genetic Counseling for Participants with Potential Germline Mutations Identified on Tumor Profiling
(Sub-study for EAY131)
Eligible for screening study DCP 001
NCT#02823652
(Click for More Info)
MCC not eligible to participate in new addendum, as EAQ152 is only open to accrual at select sites.
ECOG-ACRIN EAY131
Primary Category:
Treatment Protocols
Disease Category:
Brain, Breast, Carcinoid, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Lung, Lymphoma, Melanoma, Molecular Profiling, Other, Sarcoma
Molecular Analysis for Therapy Choice (MATCH)
Eligible for screening study DCP 001
NCT#02465060
(Click for More Info)
The protocol allows designated private sector laboratories to refer patients to the study based on genetic testing performed independent of MATCH. This is limited to genetic testing ordered for patients at approved MATCH trial sites. Approved genetic testing laboratories and their date of inclusion in the outside assay process are:
- CARIS Life Sciences – 07/02/18
- CellNetix Pathology and Laboratories – 02/13/19
- Foundation Medicine – 07/02/18
- GenPath BioReference Laboratories – 08/03/18
- The Jackson Laboratory – 01/10/19
- NeoGenomics Laboratories – 07/02/18
- OmniSeq Laboratories – 07/16/18
- PathGroup – 10/29/18
- Quest Diagnostics Inc. – 05/20/19
- Strata Oncology – 08/03/18
- Tempus Laboratories – 07/16/18
The Biopsy consent form for this study is available upon request. Please contact Amber Boerner, aboerner@mtcancer.org or 406-969-6067, for the consent & for any questions.
(http://ecog-acrin.org/nci-match-eay131-designated-labs)
GOG Foundation GOG-3015 / Y039523
Primary Category:
Treatment Protocols
Disease Category:
Gynecologic, Ovarian, Ovarian Metastatic
A Phase III, Multicenter, Randomized, Study of Atezolizumab Versus Placebo Administered in Combination With Paclitaxel, Carboplatin, and Bevacizumab to Patients With Newly-Diagnosed Stage III or Stage IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
NCT#03038100
(Click for More Info)
Limited institution study: Open ONLY to Billings Clinic, Bozeman Deaconess Cancer Center & Community Medical Center – Missoula
GOG Foundation GOG-3024/GCT1015-05
Primary Category:
Treatment Protocols
Disease Category:
Cervical, Cervical Metastatic, Gynecologic
A Phase 1b/2 Open-Label Trial of Tisotumab Vedotin (HuMax-TF-ADC) in Combination with Other Agents in Subjects with Recurrent or Stage IVB Cervical Cancer
NCT#03786081
(Click for More Info)
NRG CC004
Primary Category:
Cancer Control and Prevention Protocols
Disease Category:
Breast, Gynecologic
Phase II Double Blind Dose Finding Trial of Bupropion Versus Placebo for Sexual Desire in Women with Breast or Gynecologic Cancer
Eligible for screening study DCP 001
NCT#03180294
(Click for More Info)
This protocol has additional regulatory requirements to be completed prior to registering any patients at your site. Please contact Amber Boerner at 406-969-6067 or aboerner@mtcancer.org for additional information.
NRG G0212
Primary Category:
Treatment Protocols
Disease Category:
GYN Other, Gynecologic, Ovarian
A Randomized Phase III Trial of Maintenance Chemotherapy Comparing 12, Monthly Cycles of Single Agent Paclitaxel or CT-2103 (IND # 70177), Versus No Treatment Until Documented Relapse in Women with Advanced Ovarian, Primary Peritoneal or Fallopian Tube Cancer Who Achieve a Complete Clinical Response to Primary Platinum/Taxane Chemotherapy
NCT#00108745
(Click for More Info)
NRG G0225
Primary Category:
Cancer Control and Prevention Protocols
Disease Category:
Gynecologic
Can Diet and Physical Activity Modulate Ovarian, Fallopian Tube and Primary Peritoneal Cancer Progression-Free Survival?
G0225 will close to accrual effective Friday, August 24, 2018, because it will have reached its accrual target. Until then, please limit accrual to patients who are already in the screening process.
NCT#00719303
(Click for More Info)
Eligible for screening study DCP 001
NRG G0237
Primary Category:
Cancer Control and Prevention Protocols
Disease Category:
GYN Other
Comparative Analysis of CA-IX, p16, Proliferative Markers, and Human Papilloma Virus (HPV) in the Diagnosis of Significant Cervical Lesions in Patients with a Cytologic Diagnosis of Atypical Glandular Cells (AGC)
NCT#00892866
(Click for More Info)
Eligible for screening study DCP 001
Effective August 1st, 2019, at 3 P.M. MST, study G0237 closed to accrual.
NRG G0263
Primary Category:
Radiation Oncology, Treatment Protocols
Disease Category:
Cervical, Gynecologic
Randomized Phase III Clinical Trial of Adjuvant Radiation Versus Chemoradiation in Intermediate Risk, Stage I/IIA Cervical Cancer Treated with Initial Radical Hysterectomy and Pelvic Lymphadenectomy
Eligible for screening study DCP 001
NCT#01101451
(Click for More Info)
NRG G0270
Primary Category:
Radiation Oncology, Surgical Protocols, Treatment Protocols
Disease Category:
Gynecologic
GROningen INternational Study on Sentinel nodes in Vulvar cancer (GROINSS-V) II
NCT#01500512
(Click for More Info)
NRG G0274
Primary Category:
Radiation Oncology, Treatment Protocols
Disease Category:
Cervical, Gynecologic
A Phase III Trial of Adjuvant Chemotherapy Following Chemoradiation as Primary Treatment for Locally Advanced Cervical Cancer Compared to Chemoradiation Alone: The Outback Trial
Eligible for screening study DCP 001
NCT#01414608
(Click for More Info)
Please be aware that as of the 1st June 2017, sites are no longer permitted to screen for or provide informed consent forms for potential OUTBACK/GOG274/RTOG1174 patients as the protocol has reached its accrual goal.
NRG G0281
Primary Category:
Treatment Protocols
Disease Category:
Gynecologic, Ovarian
A Randomized Phase II/III Study to Assess the Efficacy of Trametinib (GSK 1120212) in Patients with Recurrent or Progressive Low-Grade Serous Ovarian Cancer or Peritoneal Cancer
NCT#02101788
(Click for More Info)
G0281 has met its target accrual goal in the U.S. and the study is no longer accepting any additional specimens for screening. Closure notice to follow soon.
NRG G0286B
Primary Category:
Treatment Protocols
Disease Category:
Endometrial, Endometrial Metastatic, Gynecologic
A Randomized Phase II/III Study of Paclitaxel/Carboplatin/Metformin (NSC#91485) Versus Paclitaxel/Carboplatin/Placebo as Initial Therapy for Measurable Stage III or IVA, Stage IVB, or Recurrent Endometrial Cancer
NCT#02065687
(Click for More Info)
GOG-0286B will be permanently closed to accrual effective today, February 1, 2018 due to futility.
NRG GY004
Primary Category:
Treatment Protocols
Disease Category:
Gynecologic, Ovarian
A Phase III study comparing single-agent olaparib or the combination of cediranib and olaparib to standard platinum-based chemotherapy in women with recurrent platinum sensitive ovarian, fallopian tube, or primary peritoneal cancer
NCT#02446600
(Click for More Info)
Closed to accrual effective November 10, 2017. Accrual goal met.
This protocol has additional regulatory requirements to be completed prior to registering any patients at your site. Please contact Amber Boerner at 406-969-6067 or aboerner@mtcancer.org for additional information.
NRG GY005
Primary Category:
Treatment Protocols
Disease Category:
Gynecologic, Ovarian
A Randomized Phase II/III study of the combination of Cediranib and Olaparib compared to Cediranib or Olaparib alone, or Standard of care chemotherapy in women with recurrent platinum-resistant or -refractory ovarian, fallopian tube, or primary peritoneal cancer (COCOS)
NCT#02502266
(Click for More Info)
Reactivated to accrual on Phase III with Amendment #7, 01/02/19.
This protocol has additional regulatory requirements to be completed prior to registering any patients at your site. Please contact Amber Boerner at 406-969-6067 or aboerner@mtcancer.org for additional information.
NRG GY006
Primary Category:
Radiation Oncology, Treatment Protocols
Disease Category:
Cervical, Gynecologic
A Randomized Phase III Trial of Radiation Therapy and Cisplatin Alone or in Combination with Intravenous Triapine in Women with Newly Diagnosed Bulky Stage IB2, Stage II, IIIB, or IVA Cancer of the Uterine Cervix or Stage II-IVA Vaginal Cancer
NCT#02466971
(Click for More Info)
NRG GY007
Primary Category:
Surgical Protocols, Treatment Protocols
Disease Category:
Gynecologic, Ovarian, Ovarian Metastatic
A Phase I/II Study of Ruxolitinib with Front-Line Neoadjuvant and Post-Surgical Therapy in Patients with Advanced Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer
(Click for More Info)
NCT#02713386
Study open to Phase II accrual.
This protocol has additional regulatory requirements to be completed prior to registering any patients at your site. Please contact Amber Boerner at 406-969-6067 or aboerner@mtcancer.org for additional information.
NRG GY008
Primary Category:
Treatment Protocols
Disease Category:
Endometrial, Gynecologic
A Phase II Evaluation of Copanlisib (BAY 80-6946) (IND#130822), A Selective Inhibitor of PI3KCA, in Patients with Persistent or Recurrent Endometrial Carcinoma Harboring PIK3CA Hotspot Mutations
NCT#02728258
(Click for More Info)
NRG-GY008 will not open to the second stage of accrual and is closed effective August 7th, 2017.
NRG GY009
Primary Category:
Treatment Protocols
Disease Category:
Gynecologic, Ovarian, Ovarian Metastatic
Status:
Temporarily Closed
A Randomized, Phase II/III Study of Pegylated Liposomal Doxorubicin and CTEP-Supplied Atezolizumab Versus Pegylated Liposomal Doxorubicin/Bevacizumab and CTEP-Supplied Atezolizumab Versus Pegylated Liposomal Doxorubicin/Bevacizumab in Platinum Resistant Ovarian Cancer
NCT#02839707
(Click for More Info)
NRG-GY009 has met its Phase II accrual goal and is temporarily closed effective May 9th, 2019.
NRG GY011
Primary Category:
Surgical Protocols
Disease Category:
Endometrial, Gynecologic
A Randomized Surgical Window Pilot Investigation of the Relationship of Short Term Medroxyprogesterone Acetate (NSC #26386) Compared to Medroxyprogesterone Acetate Plus Entinostat (NSC #706995) on the Morphologic, Biochemical, and Molecular Changes in Primary Endometrioid Adenocarcinoma of the Uterine Corpus
NCT#03018249
(Click for More Info)
NRG-GY011 has met its accrual goal and closed to patient entry effective February 9, 2018.
NRG GY012
Primary Category:
Treatment Protocols
Disease Category:
Endometrial, Endometrial Metastatic, Gynecologic
Status:
Temporarily Closed
A Randomized Phase II Study Comparing Single-Agent Olaparib, Single Agent Cediranib, and the Combination of Cediranib/Olaparib in Women with Recurrent, Persistent or Metastatic Endometrial Cancer
NCT#03660826
(Click for More Info)
Effective today, June 17th, 2019, study NRG GY012 has met its accrual goal and is temporarily closed.
NRG GY014
Primary Category:
Treatment Protocols
Disease Category:
Endometrial, Gynecologic, Ovarian
Status:
Temporarily Closed
A Phase II Study of Tazemetostat (EPZ-6438) (IND # 138671) in Recurrent or Persistent Endometrioid or Clear Cell Carcinoma of the Ovary, and Recurrent or Persistent Endometrioid Endometrial Adenocarcinoma
(Click for More Info)
NCT#03348631
NRG GY016
Primary Category:
Treatment Protocols
Disease Category:
Gynecologic, Ovarian
Status:
Temporarily Closed
A Phase II Study of MK-3475 (Pembrolizumab) (NSC #776864) + Epacadostat (NSC #766086) in Recurrent Clear Cell Carcinoma of the Ovary
NCT#03602586
(Click for More Info)
Effective immediately on 04/10/19, NRG-GY016 has been temporarily closed to accrual because the study has reached its maximum accrual number of 14 patients for the first stage of the trial. Accrual will be stopped until data is matured and the analysis on the first stage is complete.
NRG GY018
Primary Category:
Treatment Protocols
Disease Category:
Endometrial, Gynecologic
A Phase III Randomized, Placebo-Controlled Study of Pembrolizumab (MK-3475, NSC #776864) in Addition to Paclitaxel and Carboplatin for Measurable Stage III or IVB or Recurrent Endometrial Cancer
Eligible for screening study DCP 001
(Click for More Info)
NCT#03914612
NRG GY019
Primary Category:
Treatment Protocols
Disease Category:
Gynecologic, Ovarian, Ovarian Metastatic
A Randomized Phase III, Two-Arm Trial of Paclitaxel/Carboplatin/Maintenance Letrozole Versus Letrozole Monotherapy in Patients with Stage II-IV, Primary Low-Grade Serous Carcinoma of the Ovary or Peritoneum
Eligible for screening study DCP 001
NRG R0724
Primary Category:
Radiation Oncology, Treatment Protocols
Disease Category:
Cervical, Gynecologic
Phase III Randomized Study of Concurrent Chemotherapy and Pelvic Radiation Therapy with or without Adjuvant Chemotherapy in High-Risk Patients with Early-Stage Cervical Carcinoma Following Radical Hysterectomy
Eligible for screening study DCP 001
NCT#00980954
(Click for More Info)
NRG R1203
Primary Category:
Radiation Oncology, Treatment Protocols
Disease Category:
Cervical, Endometrial, Gynecologic
A Randomized Phase III Study of Standard vs. IMRT Pelvic Radiation for Post-Operative Treatment of Endometrial and Cervical Cancer (TIME-C)
NRG 1203 closed to accrual at 5 PM EST Thursday, August 27, 2015 because it had reached its accrual target.
NCT#01672892
(Click for More Info)
SWOG S1614
Primary Category:
Cancer Control and Prevention Protocols
Disease Category:
Brain, Breast, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Lung, Neuroendocrine, Other, Sarcoma, Skin, Thyroid
A Phase III Randomized Trial of Prophylactic Antiviral Therapy in Patients with Current or Past Hepatitis B Virus (HBV) Infection Receiving Anti-Cancer Therapy for Solid Tumors
NCT#03887702
(Click for More Info)
SWOG S1916
Primary Category:
Cancer Control and Prevention Protocols
Disease Category:
Brain, Breast, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Leukemia, Lung, Lymphoma, Multiple Myeloma, Neuroendocrine, Sarcoma, Skin, Thyroid
Status:
Upcoming - Pending IRB Review
Feasibility of a Digital Medicine Program in Optimizing Opioid Pain Control in Cancer Patients
Limited site participation. Open only to Billings Clinic.
Please see the SWOG website for any study documents not found here on the MCC website.
Head and Neck
AFT-28 CANVAS
Primary Category:
Cancer Control and Prevention Protocols
Disease Category:
Brain, Breast, Chronic Lymphocytic Leukemia, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Lung, Lymphoma, Melanoma, Multiple Myeloma, Neuroendocrine, Sarcoma
Direct Oral Anticoagulants (DOACs) versus LMWH +/- Warfarin for VTE in Cancer: A Randomized Effectiveness Trial (CANVAS Trial)
NCT#02744092
(Click for More Info)
Limited institution study – Only open to: Benefis Sletten Cancer Institute, Billings Clinic, Bozeman Health, Community Hospital of Anaconda, Community Medical Center, Kalispell Regional Medical Center, Kootenai Health, & Saint Alphonsus Regional Medical Center.
Sites must submit to MCC an AFT Delegation of Authority Log before any patient registrations may take place.
AFT-39 PROTECT
Primary Category:
Cancer Control and Prevention Protocols
Disease Category:
Anal, Bladder, Brain, Breast, Carcinoid, Cervical, Cholangiocarcinoma, Colon, Colon Metastatic, Endometrial, Esophageal, Gallbladder, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Liver, Lung, Lung - Non-Small Cell, Lung - Small Cell, Lymphoma, Melanoma, Multiple Myeloma, Neuroendocrine, Ovarian, Pancreatic, Prostate, Rectal, Renal, Sarcoma, Stomach, Thyroid, Uterine
Electronic patient reporting of symptoms during outpatient cancer treatment: A U.S. national randomized controlled trial (the “PRO-TECT” trial)
NCT#03249090
(Click for More Info)
Limited institution study – Only open to: Billings Clinic & Bozeman Health
Effective, October 25th, 2019, the CONTROL arm of AFT 39, is closed to accrual.
ALLIANCE A091404
Primary Category:
Treatment Protocols
Disease Category:
Head and Neck
A Phase II Study of Enzalutamide (NSC# 766085) for Patients with Androgen Receptor Positive Salivary Cancers
NCT#02749903
(Click for More Info)
Effective August 31, 2018, Alliance A091404 is closed to accrual.
ECOG-ACRIN E1305
Primary Category:
Treatment Protocols
Disease Category:
Head and Neck, Head and Neck Metastatic
A Phase III Randomized Trial of Chemotherapy with or Without Bevacizumab in Patients with Recurrent or Metastatic Head and Neck Cancer
NCT#00588770
(Click for More Info)
ECOG-ACRIN EA3132
Primary Category:
Radiation Oncology, Treatment Protocols
Disease Category:
Head and Neck
Phase II Randomized Trial of Adjuvant Radiotherapy with or Without Cisplatin for p53 Mutated, Surgically Resected Squamous Cell Carcinoma of the Head and Neck (SCCHN)
NCT#02734537
(Click for More Info)
ECOG-ACRIN EA3161
Primary Category:
Treatment Protocols
Disease Category:
Head and Neck
Nivolumab Versus Observation in Treating Patients With Locally Advanced, Intermediate Risk HPV-Positive Oropharyngeal Cancer
NCT#03811015
(Click for More Info)
ECOG-ACRIN EA3163
Primary Category:
Radiation Oncology, Surgical Protocols, Treatment Protocols
Disease Category:
Head and Neck
Phase II randomized trial of neo-adjuvant chemotherapy followed by surgery and post-operative radiation versus surgery and post-operative radiation for organ preservation of T3 and T4a nasal and paranasal sinus squamous cell carcinoma (NPNSCC)
NCT#03493425
(Click for More Info)
ECOG-ACRIN EAQ152
Primary Category:
Cancer Control and Prevention Protocols
Disease Category:
Brain, Breast, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Lung, Lymphoma, Melanoma, Molecular Profiling, Other, Sarcoma
COMET – Communication and Education in Tumor Profiling: A Randomized Study of Pre-disclosure Genetic Education v. Usual Care in Tumor Profiling for Advanced Cancer and a Pilot Study of Remote Genetic Counseling for Participants with Potential Germline Mutations Identified on Tumor Profiling
(Sub-study for EAY131)
Eligible for screening study DCP 001
NCT#02823652
(Click for More Info)
MCC not eligible to participate in new addendum, as EAQ152 is only open to accrual at select sites.
ECOG-ACRIN EAY131
Primary Category:
Treatment Protocols
Disease Category:
Brain, Breast, Carcinoid, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Lung, Lymphoma, Melanoma, Molecular Profiling, Other, Sarcoma
Molecular Analysis for Therapy Choice (MATCH)
Eligible for screening study DCP 001
NCT#02465060
(Click for More Info)
The protocol allows designated private sector laboratories to refer patients to the study based on genetic testing performed independent of MATCH. This is limited to genetic testing ordered for patients at approved MATCH trial sites. Approved genetic testing laboratories and their date of inclusion in the outside assay process are:
- CARIS Life Sciences – 07/02/18
- CellNetix Pathology and Laboratories – 02/13/19
- Foundation Medicine – 07/02/18
- GenPath BioReference Laboratories – 08/03/18
- The Jackson Laboratory – 01/10/19
- NeoGenomics Laboratories – 07/02/18
- OmniSeq Laboratories – 07/16/18
- PathGroup – 10/29/18
- Quest Diagnostics Inc. – 05/20/19
- Strata Oncology – 08/03/18
- Tempus Laboratories – 07/16/18
The Biopsy consent form for this study is available upon request. Please contact Amber Boerner, aboerner@mtcancer.org or 406-969-6067, for the consent & for any questions.
(http://ecog-acrin.org/nci-match-eay131-designated-labs)
NRG HN002
Primary Category:
Radiation Oncology, Treatment Protocols
Disease Category:
Head and Neck
A Randomized Phase II Trial for Patients with p16 Positive, Non-Smoking Associated, Locoregionally Advanced Oropharyngeal Cancer
NCT#02254278
(Click for More Info)
Closed effective 02/07/17. Accrual goal met.
NRG HN004
Primary Category:
Radiation Oncology, Treatment Protocols
Disease Category:
Head and Neck
Randomized Phase II/III Trial of Radiotherapy with Concurrent MEDI4736 (Durvalumab) Vs. Radiotherapy with Concurrent Cetuximab in Patients with Stage III-IVB Head and Neck Cancer with a Contraindication to Cisplatin
NCT#03258554
(Click for More Info)
Site Delegation of Tasks Log required prior to registration of any patients.
NRG HN005
Primary Category:
Radiation Oncology
Disease Category:
Head and Neck
A Randomized Phase II/II Trial of De-Intensified Radiation Therapy for Patients With Early-Stage, P16-Positive, Non-Smoking Associated Oropharyngeal Cancer
Open to Phase II enrollment
(Click for More Info)
NRG R0920
Primary Category:
Radiation Oncology, Treatment Protocols
Disease Category:
Head and Neck
A Phase III Study of Postoperative Radiation Therapy (IMRT) +/- Cetuximab for Locally-Advanced Resected Head and Neck Cancer
Eligible for screening study DCP 001
NCT#00956007
(Click for More Info)
R0920 is closed to accrual as of 5 PM ET Tuesday, March 27, 2018, because it has reached its accrual target.
NRG R1008
Primary Category:
Radiation Oncology, Treatment Protocols
Disease Category:
Head and Neck
A Randomized Phase II/Phase III Study of Adjuvant Concurrent Radiation and Chemotherapy Versus Radiation Alone in Resected High-Risk Malignant Salivary Gland Tumors
NCT#01220583
(Click for More Info)
SWOG S1614
Primary Category:
Cancer Control and Prevention Protocols
Disease Category:
Brain, Breast, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Lung, Neuroendocrine, Other, Sarcoma, Skin, Thyroid
A Phase III Randomized Trial of Prophylactic Antiviral Therapy in Patients with Current or Past Hepatitis B Virus (HBV) Infection Receiving Anti-Cancer Therapy for Solid Tumors
NCT#03887702
(Click for More Info)
SWOG S1916
Primary Category:
Cancer Control and Prevention Protocols
Disease Category:
Brain, Breast, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Leukemia, Lung, Lymphoma, Multiple Myeloma, Neuroendocrine, Sarcoma, Skin, Thyroid
Status:
Upcoming - Pending IRB Review
Feasibility of a Digital Medicine Program in Optimizing Opioid Pain Control in Cancer Patients
Limited site participation. Open only to Billings Clinic.
Please see the SWOG website for any study documents not found here on the MCC website.
Leukemia
AFT-28 CANVAS
Primary Category:
Cancer Control and Prevention Protocols
Disease Category:
Brain, Breast, Chronic Lymphocytic Leukemia, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Lung, Lymphoma, Melanoma, Multiple Myeloma, Neuroendocrine, Sarcoma
Direct Oral Anticoagulants (DOACs) versus LMWH +/- Warfarin for VTE in Cancer: A Randomized Effectiveness Trial (CANVAS Trial)
NCT#02744092
(Click for More Info)
Limited institution study – Only open to: Benefis Sletten Cancer Institute, Billings Clinic, Bozeman Health, Community Hospital of Anaconda, Community Medical Center, Kalispell Regional Medical Center, Kootenai Health, & Saint Alphonsus Regional Medical Center.
Sites must submit to MCC an AFT Delegation of Authority Log before any patient registrations may take place.
ALLIANCE A041202
Primary Category:
Treatment Protocols
Disease Category:
Chronic Lymphocytic Leukemia, Leukemia
A Randomized Phase III Study Of Bendamustine PLUS Rituximab Versus Ibrutinib Plus Rituximab Versus Ibrutinib Alone In Untreated Older Patients (≥ 65 Years Of Age) With Chronic Lymphocytic Leukemia (CLL)
A041202 will soon meet its accrual goal. Therefore, EFFECTIVE MONDAY, DECEMBER 28, 2015 at 4:30 pm ET, A041202 will permanently close to new patient pre-registration (Step 0).
A041202 has met its accrual goal. Therefore, EFFECTIVE MONDAY, May 16, 2016 at 4:30 pm ET, A041202 will permanently close to new patient registration (Step 1).
NCT#01886872
(Click for More Info)
ALLIANCE A041501
Primary Category:
Treatment Protocols
Disease Category:
Acute Lymphocytic Leukemia, Leukemia
A Phase III Trial to Evaluate the Efficacy of the Addition of Inotuzumab Ozogamicin (a Conjugated Anti-CD22 Monoclonal Antibody) to Frontline Therapy in Young Adults (Ages 18-39 Years) with Newly Diagnosed Precursor B-Cell ALL
NCT#03150693
(Click for More Info)
Eligible for screening study DCP 001
ALLIANCE A041701
Primary Category:
Treatment Protocols
Disease Category:
Acute Myeloid Leukemia, Leukemia
A Randomized Phase II/III Study of Conventional Chemotherapy +/- Uproleselan (GMI-1271) in Older Adults with Acute Myeloid Leukemia Receiving Intensive Induction Chemotherapy
NCT#03701308
(Click for More Info)
ALLIANCE A041702
Primary Category:
Treatment Protocols
Disease Category:
Chronic Lymphocytic Leukemia, Leukemia
A Randomized Phase III Study of Ibrutinib Plus Obinutuzumab Versus Ibrutinib Plus Venetoclax and Obinutuzumab in Untreated Older Patients (>/= 70 Years of Age) with Chronic Lymphocytic Leukemia (CLL)
NCT#03737981
(Click for More Info)
Eligible for screening study DCP 001
ECOG-ACRIN E1910
Primary Category:
Treatment Protocols
Disease Category:
Acute Lymphocytic Leukemia, Leukemia
A Phase III Randomized Trial of Blinatumomab for Newly Diagnosed BCR-ABL-negative B lineage Acute Lymphoblastic Leukemia in Adults
Eligible for screening study DCP 001
NCT#02003222
(Click for More Info)
Due to the completion of accrual, E1910 will be closed to accrual effective October 15, 2019.
ECOG-ACRIN E1912
Primary Category:
Treatment Protocols
Disease Category:
Chronic Lymphocytic Leukemia, Leukemia
A Randomized Phase III Study of Ibrutinib (PCI-32765)-based Therapy vs Standard Fludarabine, Cyclophosphamide, and Rituximab (FCR) Chemoimmunotherapy in Untreated Younger Patients with Chronic Lymphocytic Leukemia (CLL)
E1912 will close to Accrual Effective June 9, 2016 at 5:00 pm ET due to reaching its accrual goal.
NCT#02048813
(Click for More Info)
ECOG-ACRIN EA9161
Primary Category:
Treatment Protocols
Disease Category:
Chronic Lymphocytic Leukemia, Leukemia
A Randomized Phase III Study of the Addition of Venetoclax to Ibrutinib and Obinutuzumab Versus Ibrutinib and Obinutuzumab in Untreated Younger Patients with Chronic Lymphocytic Leukemia (CLL)
NCT#03701282
(Click for More Info)
Eligible for screening study DCP 001
ECOG-ACRIN EA9171
Primary Category:
Treatment Protocols
Disease Category:
Chronic Myeloid Leukemia, Leukemia
Phase II Study of Adding the Anti-PD-1 Pembrolizumab to Tyrosine Kinase Inhibitors in Patients with Chronic Myeloid Leukemia and Persistently Detectable Minimal Residual Disease
NCT#03516279
(Click for More Info)
ECOG-ACRIN NHLBI-MDS
Primary Category:
Cancer Control and Prevention Protocols
Disease Category:
Leukemia, Myelodysplastic Syndrome
The National Myelodysplastic Syndromes (MDS) Study
NCT#02775383
(Click for More Info)
Eligible for screening study DCP 001
This protocol has additional regulatory requirements to be completed prior to registering any patients at your site. Please contact Amber Boerner at 406-969-6067 or aboerner@mtcancer.org for additional information.
SWOG S1203
Primary Category:
Treatment Protocols
Disease Category:
Acute Myeloid Leukemia, Leukemia
A Randomized Phase III Study of Standard Cytarabine Plus Daunorubicin (7+3) Therapy or Idarubicin with High Dose Cytarabine (IA) Versus IA with Vorinostat (NSC-701852) (IA+V) in Younger Patients with Previously Untreated Acute Myeloid Leukemia (AML)
S1203 is fast-approaching its accrual goal and will permanently close to accrual effective November 4, 2015 at 11:59 pm Pacific Time.
NCT#01802333
(Click for More Info)
SWOG S1612
Primary Category:
Treatment Protocols
Disease Category:
Acute Myeloid Leukemia, Leukemia, Myelodysplastic Syndrome
Status:
Temporarily Closed
A Randomized Phase II/III Trial of “Novel Therapeutics” versus Azacitidine in Newly Diagnosed Patients with Acute Myeloid Leukemia (AML) or High-Risk Myelodysplastic Syndrome (MDS), Age 60 or Older
NCT#03092674
(Click for More Info)
Effective immediately,10/25/18, and until further notice, patients will no longer receive nivolumab as part of this study. Additional details are provided in the Investigator Letter and Patient Information Letter.
Effective immediately, 10/22/18, S1612 will be temporarily closed to accrual based on additional review of the safety data. An “Investigator Letter” and “Patient Notification Letter” will be provided in the coming days, pending regulatory approvals.
SWOG S1712
Primary Category:
Treatment Protocols
Disease Category:
Chronic Myeloid Leukemia, Leukemia
A Randomized Phase II Study of Ruxolitinib (NSC-752295) in Combination with BCR-ABL Tyrosine Kinase Inhibitors in Chronic Myeloid Leukemia (CML) Patients with Molecular Evidence of Disease
NCT#03654768
(Click for More Info)
SWOG S1916
Primary Category:
Cancer Control and Prevention Protocols
Disease Category:
Brain, Breast, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Leukemia, Lung, Lymphoma, Multiple Myeloma, Neuroendocrine, Sarcoma, Skin, Thyroid
Status:
Upcoming - Pending IRB Review
Feasibility of a Digital Medicine Program in Optimizing Opioid Pain Control in Cancer Patients
Limited site participation. Open only to Billings Clinic.
Please see the SWOG website for any study documents not found here on the MCC website.
Lung
AFT-28 CANVAS
Primary Category:
Cancer Control and Prevention Protocols
Disease Category:
Brain, Breast, Chronic Lymphocytic Leukemia, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Lung, Lymphoma, Melanoma, Multiple Myeloma, Neuroendocrine, Sarcoma
Direct Oral Anticoagulants (DOACs) versus LMWH +/- Warfarin for VTE in Cancer: A Randomized Effectiveness Trial (CANVAS Trial)
NCT#02744092
(Click for More Info)
Limited institution study – Only open to: Benefis Sletten Cancer Institute, Billings Clinic, Bozeman Health, Community Hospital of Anaconda, Community Medical Center, Kalispell Regional Medical Center, Kootenai Health, & Saint Alphonsus Regional Medical Center.
Sites must submit to MCC an AFT Delegation of Authority Log before any patient registrations may take place.
AFT-39 PROTECT
Primary Category:
Cancer Control and Prevention Protocols
Disease Category:
Anal, Bladder, Brain, Breast, Carcinoid, Cervical, Cholangiocarcinoma, Colon, Colon Metastatic, Endometrial, Esophageal, Gallbladder, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Liver, Lung, Lung - Non-Small Cell, Lung - Small Cell, Lymphoma, Melanoma, Multiple Myeloma, Neuroendocrine, Ovarian, Pancreatic, Prostate, Rectal, Renal, Sarcoma, Stomach, Thyroid, Uterine
Electronic patient reporting of symptoms during outpatient cancer treatment: A U.S. national randomized controlled trial (the “PRO-TECT” trial)
NCT#03249090
(Click for More Info)
Limited institution study – Only open to: Billings Clinic & Bozeman Health
Effective, October 25th, 2019, the CONTROL arm of AFT 39, is closed to accrual.
ALLIANCE A081105
Primary Category:
Treatment Protocols
Disease Category:
Lung, Lung - Non-Small Cell, Molecular Profiling
Randomized Double Blind Placebo Controlled Study of Erlotinib or Placebo in Patients with Completely Resected Epidermal Growth Factor Receptor (EGFR) Mutant Non-Small Cell Lung Cancer (NSCLC)
(See required screening study ALLIANCE A151216)
Eligible for screening study DCP 001
NCT#02193282
(Click for More Info)
ALLIANCE A151216
Primary Category:
Treatment Protocols
Disease Category:
Lung, Lung - Non-Small Cell, Molecular Profiling
Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial (ALCHEMIST)
A screening trial for A081105, E4512, and EA5142.
Eligible for screening study DCP 001
Effective, August 26, 2019, enrollment is temporarily suspended for patients with squamous histology.
NCT#02194738
(Click for More Info)
ALLIANCE A211401
Primary Category:
Cancer Control and Prevention Protocols, Surgical Protocols
Disease Category:
Lung, Lung - Non-Small Cell, Lung - Small Cell
Reducing Surgical Complications in Newly Diagnosed Lung Cancer Patients Who Smoke Cigarettes
NCT#02856581
(Click for More Info)
Effective today, November 15th, 2019, study A211401, is permanently closed to new patient registration.
ALLIANCE A221504
Primary Category:
Cancer Control and Prevention Protocols
Disease Category:
Lung, Lung - Non-Small Cell, Lung - Non-Small Cell Metastatic
A Randomized, Double-Blind, Placebo-Controlled Pilot Study of an Oral, Selective Peripheral Opioid Receptor Antagonist in Advanced Non-Small Cell Lung Cancer (Adenocarcinoma)
NCT#03087708
(Click for More Info)
Eligible for screening study DCP 001
ALLIANCE C140503
Primary Category:
Surgical Protocols
Disease Category:
Lung, Lung - Non-Small Cell
A Phase III Randomized Trial of Lobectomy versus Sublobar Resection for Small (≤ 2 cm)
Peripheral Non-Small Cell Lung Cancer
(See Section 9.0 for required surgical credentialing.)
NCT#00499330
(Click for More Info)
C140503 has met its accrual goal. Therefore, effective Monday, March 13, 2017 at 4:30 pm EDT, CALGB 140503 will permanently close to new patient pre-registration. Patients that have been pre-registered on or before March 13, 2017 may continue the process to be registered.
ALLIANCE C30610
Primary Category:
Radiation Oncology, Treatment Protocols
Disease Category:
Lung, Lung - Small Cell, Lung - Small Cell Limited Stage
Phase III Comparison of Thoracic Radiotherapy Regimens in Patients with Limited Small Cell Lung Cancer Also Receiving Cisplatin and Etoposide
Eligible for screening study DCP 001
NCT#00632853
(Click for More Info)
Effective December 1st, 2019, study CALGB 30610 is permanently closed to new patient accrual.
ECOG-ACRIN E4512
Primary Category:
Treatment Protocols
Disease Category:
Lung, Lung - Non-Small Cell, Molecular Profiling
A Phase III Double-Blind Trial for Surgically Resected Early Stage Non-Small Cell Lung Cancer: Crizotinib versus Placebo for Patients with Tumors Harboring the Anaplastic Lymphoma Kinase (ALK) Fusion Protein
(See required screening study ALLIANCE A151216)
Eligible for screening study DCP 001
NCT#02201992
(Click for More Info)
ECOG-ACRIN E5508
Primary Category:
Treatment Protocols
Disease Category:
Lung, Lung - Non-Small Cell, Lung - Non-Small Cell Metastatic
Randomized Phase III Study of Maintenance Therapy with Bevacizumab, Pemetrexed, or a Combination of Bevacizumab and Pemetrexed Following Carboplatin, Paclitaxel and Bevacizumab for Advanced Non-Squamous NSCLC
E5508 is approaching its Step 1 accrual goal. Therefore, this study will close Step 1 accrual effective May 8, 2015 at 5:00 p.m. EST for registrations. Patients registered to Step 1 by this time may still register to Step 2 as outlined in the protocol.
NCT#01107626
(Click for More Info)
ECOG-ACRIN EA5142
Primary Category:
Treatment Protocols
Disease Category:
Lung, Lung - Non-Small Cell, Molecular Profiling
Adjuvant Nivolumab in Resected Lung Cancers (ANVIL)-A Randomized Phase III Study of Nivolumab After Surgical Resection and Adjuvant Chemotherapy in Non-Small Cell Lung Cancers
(See required screening study ALLIANCE A151216)
Eligible for screening study DCP 001
NCT#02595944
(Click for More Info)
Effective today, October 1st, 2019, study EA5142 has met accrual goals and is permanently closed to accrual.
This protocol has additional regulatory requirements to be completed prior to registering any patients at your site. Please contact Amber Boerner at 406-969-6067 or aboerner@mtcancer.org for additional information.
ECOG-ACRIN EA5152
Primary Category:
Treatment Protocols
Disease Category:
Lung, Lung - Non-Small Cell, Lung - Non-Small Cell Metastatic
A Randomized Phase II Trial of Nivolumab, Cabozantinib Plus Nivolumab, and Cabozantinib Plus Nivolumab Plus Ipilimumab in Patients with Previously Treated Non-Squamous NSCLC
NCT#03468985
(Click for More Info)
Effective May 31st, 2019, EA5152 is closed to accrual while the redesign developed for chemo/immunotherapy refractory patients will be opened as a new trial.
ECOG-ACRIN EA5161
Primary Category:
Treatment Protocols
Disease Category:
Lung, Lung - Small Cell, Lung - Small Cell Extensive Stage
Randomized Phase II Clinical Trial of Cisplatin/Carboplatin and Etoposide (CE) Alone or in Combination with Nivolumab as Frontline Therapy for Extensive Stage Small Cell Lung Cancer (ED-SCLC)
NCT#03382561
(Click for More Info)
EA5161 is successfully approaching its accrual goal, therefore, this study will be closed to accrual effective December 7, 2018 at 5:00 PM ET.
ECOG-ACRIN EA5162
Primary Category:
Treatment Protocols
Disease Category:
Lung, Lung - Non-Small Cell, Lung - Non-Small Cell Metastatic
Status:
Temporarily Closed
Phase II Study of AZD9291 (Osimertinib) in Advanced NSCLC Patients with Exon 20 Insertion Mutations in EGFR
NCT#03191149
(Click for More Info)
Effective, July 2, 2019, study EA5162 is temporarily closed to accrual.
ECOG-ACRIN EA5163
Primary Category:
Treatment Protocols
Disease Category:
Lung, Lung - Non-Small Cell, Lung - Non-Small Cell Metastatic
EA5163/S1709 INSIGNA : A Randomized, Phase III Study of Firstline Immunotherapy Alone or in Combination with Chemotherapy in Induction/Maintenance or Postprogression in Advanced Nonsquamous Non-Small Cell Lung Cancer (NSCLC) with Immunobiomarker SIGNature-Driven Analysis
NCT#03793179
(Click for More Info)
ECOG-ACRIN EAQ152
Primary Category:
Cancer Control and Prevention Protocols
Disease Category:
Brain, Breast, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Lung, Lymphoma, Melanoma, Molecular Profiling, Other, Sarcoma
COMET – Communication and Education in Tumor Profiling: A Randomized Study of Pre-disclosure Genetic Education v. Usual Care in Tumor Profiling for Advanced Cancer and a Pilot Study of Remote Genetic Counseling for Participants with Potential Germline Mutations Identified on Tumor Profiling
(Sub-study for EAY131)
Eligible for screening study DCP 001
NCT#02823652
(Click for More Info)
MCC not eligible to participate in new addendum, as EAQ152 is only open to accrual at select sites.
ECOG-ACRIN EAY131
Primary Category:
Treatment Protocols
Disease Category:
Brain, Breast, Carcinoid, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Lung, Lymphoma, Melanoma, Molecular Profiling, Other, Sarcoma
Molecular Analysis for Therapy Choice (MATCH)
Eligible for screening study DCP 001
NCT#02465060
(Click for More Info)
The protocol allows designated private sector laboratories to refer patients to the study based on genetic testing performed independent of MATCH. This is limited to genetic testing ordered for patients at approved MATCH trial sites. Approved genetic testing laboratories and their date of inclusion in the outside assay process are:
- CARIS Life Sciences – 07/02/18
- CellNetix Pathology and Laboratories – 02/13/19
- Foundation Medicine – 07/02/18
- GenPath BioReference Laboratories – 08/03/18
- The Jackson Laboratory – 01/10/19
- NeoGenomics Laboratories – 07/02/18
- OmniSeq Laboratories – 07/16/18
- PathGroup – 10/29/18
- Quest Diagnostics Inc. – 05/20/19
- Strata Oncology – 08/03/18
- Tempus Laboratories – 07/16/18
The Biopsy consent form for this study is available upon request. Please contact Amber Boerner, aboerner@mtcancer.org or 406-969-6067, for the consent & for any questions.
(http://ecog-acrin.org/nci-match-eay131-designated-labs)
NRG CC003
Primary Category:
Radiation Oncology
Disease Category:
Brain, Lung, Lung - Small Cell, Lung - Small Cell Extensive Stage, Lung - Small Cell Limited Stage
Randomized Phase II/III Trial of Prophylatic Cranial Irradiation With or Without Hippocampal Avoidance for Small Cell Lung Cancer
NCT#02635009
(Click for More Info)
Eligible for screening study DCP 001
Reactivation to Phase III accrual as of 01/09/19.
NRG LU001
Primary Category:
Radiation Oncology, Treatment Protocols
Disease Category:
Lung, Lung - Non-Small Cell
Randomized Phase II Trial of Concurrent Chemoradiotherapy +/- Metformin HCL in Locally Advanced NSCLC
LU001 is closed effective December 15, 2016 because it has reached its accrual target.
NCT#02186847
(Click for More Info)
NRG LU002
Primary Category:
Radiation Oncology, Treatment Protocols
Disease Category:
Lung, Lung - Non-Small Cell, Lung - Non-Small Cell Metastatic
Maintenance Systemic Therapy Versus Consolidative Stereotactic Body Radiation Therapy (SBRT) Plus Maintenance Systemic Therapy for Limited Metastatic Non-Small Cell Lung Cancer (NSCLC): A Randomized Phase II/III Trial
NCT#03137771
(Click for More Info)
NRG LU003
Primary Category:
Treatment Protocols
Disease Category:
Lung, Lung - Non-Small Cell, Lung - Non-Small Cell Metastatic
A Biomarker-Driven Protocol for Previously Treated ALK-Positive Non-Squamous NSCLC Patients: The NCI-NRG ALK Master Protocol
(Click for More Info)
NCT#03737994
Treatment consent forms for individual agents for this study are available upon request when a patient at your site is assigned to a study agent. Please contact Jodi Fischer, jfischer@mtcancer.org or 406-969-6068, for the consents & for any questions.
NRG LU004
Primary Category:
Radiation Oncology, Treatment Protocols
Disease Category:
Lung, Lung - Non-Small Cell
Phase I Trial of Accelerated or Conventionally Fractionated Radiotherapy Combined with MEDI4736 (Durvalumab) in PD-L1 High Locally Advanced Non-Small Cell Lung Cancer (NSCLC) (ARCHON-1)
NCT#03801902
(Click for More Info)
NRG LU005
Primary Category:
Radiation Oncology, Treatment Protocols
Disease Category:
Lung, Lung - Small Cell, Lung - Small Cell Limited Stage
Limited Stage Small Cell Lung Cancer (LS-SCLC): A Phase II/III Randomized Study of Chemoradiation Versus Chemoradiation Plus Atezolizumab
Site staff must complete Rave ePro online training prior to the first patient enrollment.
NCT#03811002
(Click for More Info)
NRG R1306
Primary Category:
Radiation Oncology, Treatment Protocols
Disease Category:
Lung, Lung - Non-Small Cell
A Randomized Phase II Study of Individualized Combined Modality Therapy for Stage III Non-Small Cell Lung Cancer (NSCLC)
NCT#01822496
(Click for More Info)
R1306 will close to accrual at 5 PM EST Wednesday, December 20, 2017, because we were unable to meet the projected accrual goals due to low prevalence of patients with EGFR mutant and ALK translocation tumors.
SWOG LUNGMAP
Primary Category:
Treatment Protocols
Disease Category:
Lung, Lung - Non-Small Cell, Lung - Non-Small Cell Metastatic
A Master Protocol to Evaluate Biomarker-Driven Therapies and Immunotherapies in Previously-Treated Non-Small Cell Lung Cancer (Lung-MAP Screening Study)
NCT#03851445
(Click for More Info)
Eligible for screening study DCP 001
Effective, June 30th, 2019, the sub-study S1400GEN is closed to accrual.
SWOG S1400
Primary Category:
Treatment Protocols
Disease Category:
Lung, Lung - Non-Small Cell, Lung - Non-Small Cell Metastatic, Molecular Profiling
A Biomarker-Driven Master Protocol for Previously Treated Squamous Cell Lung Cancer
Eligible for screening study DCP 001
NCT#02154490
(Click for More Info)
Closure to accrual for S1400 will be effective 2:00 p.m. Pacific Time on January 28, 2019.
SWOG S1400A
Primary Category:
Treatment Protocols
Disease Category:
Lung, Lung - Non-Small Cell, Lung - Non-Small Cell Metastatic, Molecular Profiling
A Phase II Study of MEDI4736 for Previously Treated Patients with Stage IV Squamous Cell Lung Cancer and No Matching Biomarkers (Lung-MAP Sub-Study)
(See required screening study SWOG S1400)
Permanent Closure of S1400A, Arm 2-Docetaxel due to FDA approval of nivolumab. Permanent closure of sub-study due to a revised trial design.
NCT#02154490
(Click for More Info)
SWOG S1400B
Primary Category:
Treatment Protocols
Disease Category:
Lung, Lung - Non-Small Cell, Lung - Non-Small Cell Metastatic, Molecular Profiling
A Phase II Study of GDC-0032 (Taselisib) for Previously Treated PI3K Positive Patients with Stage IV Squamous Cell Lung Cancer (Lung-MAP Sub-Study)
(See required screening study SWOG S1400)
S1400B is closed to accrual effective December 12, 2016, as the study did not meet the criterion for the interim futility analysis.
NCT#02154490
(Click for More Info)
SWOG S1400C
Primary Category:
Treatment Protocols
Disease Category:
Lung, Lung - Non-Small Cell, Lung - Non-Small Cell Metastatic, Molecular Profiling
A Phase II Study of Palbociclib for Previously Treated Cell Cycle Gene Alteration Positive Patients with Stage IV Squamous Cell Lung Cancer (Lung-MAP Sub-Study)
(See required screening study SWOG S1400)
Permanent closure of Arm 2 ONLY due to a revised trial design.
S1400C will be permanently closed to accrual, effective September 1, 2016, as the study did not meet the criterion for the interim futility analysis.
NCT#02154490
(Click for More Info)
SWOG S1400D
Primary Category:
Treatment Protocols
Disease Category:
Lung, Lung - Non-Small Cell, Lung - Non-Small Cell Metastatic, Molecular Profiling
A Phase II Study of AZD4547 for Previously Treated FGFR-Positive Patients with Stage IV Squamous Cell Lung Cancer (Lung-MAP Sub-Study)
(See required screening study SWOG S1400)
Effective 11:59 p.m. Pacific Time on October 31, 2016, the following sub-study will be permanently closed to accrual, as the study did not meet the criterion for the interim futility analysis.
NCT#02154490
(Click for More Info)
SWOG S1400E
Primary Category:
Treatment Protocols
Disease Category:
Lung, Lung - Non-Small Cell, Lung - Non-Small Cell Metastatic, Molecular Profiling
A Phase II/III Randomized Study of Rilotumumab Plus Erlotinib Versus Erlotinib as Second Line Therapy for C-MET Positive Patients with Stage IV Squamous Cell Lung Cancer (Lung-Map Sub-Study)
(See required screening study SWOG S1400)
NCT#02154490
(Click for More Info)
SWOG S1400F
Primary Category:
Treatment Protocols
Disease Category:
Lung, Lung - Non-Small Cell, Lung - Non-Small Cell Metastatic, Molecular Profiling
A Phase II Study of MEDI4736 (Durvalumab) plus Tremelimumab as Therapy for Patients with Previously Treated ANTIPD-1/PD-L1 Resistant Stage IV Squamous Cell Lung Cancer (Lung-MAP Non-Match Sub-Study)
See Screening Protocol LUNGMAP
NCT#03373760
(Click for More Info)
Effective November 6th, 2019 at 2:00 pm Pacific Time, Cohort 1, the acquired resistance cohort of substudy S1400F will permanently close to accrual. Please note that Cohort 2, the primary resistance cohort, has been reactivated and is open to accrual.
SWOG S1400G
Primary Category:
Treatment Protocols
Disease Category:
Lung, Lung - Non-Small Cell, Lung - Non-Small Cell Metastatic, Molecular Profiling
A Phase II Study of Talazoparib (BMN 673) in Patients with Homologous Recombination Repair Deficiency Positive Stage IV Squamous Cell Lung Cancer (Lung-MAP Sub-Study)
(See required screening study SWOG S1400)
NCT#03377556
(Click for More Info)
Effective July 23, 2018, the following sub-study, S1400G, will be permanently closed.
SWOG S1400I
Primary Category:
Treatment Protocols
Disease Category:
Lung, Lung - Non-Small Cell, Lung - Non-Small Cell Metastatic, Molecular Profiling
A Phase III Randomized Study of Nivolumab Plus Ipilimumab Versus Nivolumab for Previously Treated Patients with Stage IV Squamous Cell Lung Cancer and No Matching Biomarker (Lung-MAP Sub-Study)
Eligible for screening study DCP 001
(See required screening study SWOG S1400)
NCT#02785952
(Click for More Info)
S1400I is permanently closed to accrual effective immediately, 04/23/18. At a planned interim analysis, SWOG’s Data and Safety Monitoring Committee recommended that sub study S1400I be permanently closed to accrual based on the results. This information will be shared and further instructions given in a forthcoming letter to patients and investigators. Patients currently receiving the experimental combination nivolumab plus ipilimumab may continue to receive treatment if the patient is deriving clinical benefit, the patient agrees to continue treatment, and if their physician feels that it is in the best interest of the patient to continue the treatment as an appropriate medical intervention at this time. Patients on both arms should continue study follow-up.
SWOG S1400K
Primary Category:
Treatment Protocols
Disease Category:
Lung, Lung - Non-Small Cell, Lung - Non-Small Cell Metastatic, Molecular Profiling
A Phase II Study of ABBV-399 (Process II) in Patients with
c-Met Positive Stage IV or Recurrent Squamous Cell Lung Cancer
(Lung-MAP Sub-Study)
S1400K will be temporarily closed to accrual 10/18/18 based on additional review of the safety data.
At a planned interim analysis, the study team reviewed patient data to date and did not find that every 3-week dosing of ABBV-399 was sufficiently active to continue enrolling patient to the study. S1400K will be permanently closed, on 12/21/18, to accrual based on the results.
(See required screening study SWOG S1400)
NCT#03574753
(Click for More Info)
SWOG S1403
Primary Category:
Treatment Protocols
Disease Category:
Lung, Lung - Non-Small Cell, Lung - Non-Small Cell Metastatic
Randomized Phase II/III Trial of Afatinib Plus Cetuximab Versus Afatinib Alone in Treatment-Naive Patients with Advanced, EGFR Mutation Positive Non-Small Cell Lung Cancer (NSCLC)
NCT#02438722
(Click for More Info)
S1403 is permanently closed to accrual effective immediately, 04/23/18. Additional information is forthcoming.
SWOG S1507
Primary Category:
Treatment Protocols
Disease Category:
Lung, Lung - Non-Small Cell, Lung - Non-Small Cell Metastatic
A Phase II Trial of Trametinib with Docetaxel in Patients with Kras Mutation Positive Non-Small Cell Lung Cancer (NSCLC) and Progressive Disease Following One or Two Prior Systemic Therapies
NCT#02642042
(Click for More Info)
S1507 has met its accrual goal and will permanently close to accrual effective March 15, 2018 at 11:59 p.m. Pacific.
SWOG S1614
Primary Category:
Cancer Control and Prevention Protocols
Disease Category:
Brain, Breast, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Lung, Neuroendocrine, Other, Sarcoma, Skin, Thyroid
A Phase III Randomized Trial of Prophylactic Antiviral Therapy in Patients with Current or Past Hepatitis B Virus (HBV) Infection Receiving Anti-Cancer Therapy for Solid Tumors
NCT#03887702
(Click for More Info)
SWOG S1619
Primary Category:
Radiation Oncology, Surgical Protocols, Treatment Protocols
Disease Category:
Lung, Mesothelioma
A Feasibility Trial of Neoadjuvant Cisplatin-Pemetrexed with Atezolizumab in Combination and in Maintenance for Resectable Malignant Pleural Mesothelioma
NCT#03228537
(Click for More Info)
Eligible for screening study DCP 001
Effective immediately, August 12, 2019, study SWOG S1619 has reopened to accrual.
SWOG S1800A
Primary Category:
Treatment Protocols
Disease Category:
Lung, Lung - Non-Small Cell, Lung - Non-Small Cell Metastatic
A Phase II Randomized Study of Ramucirumab Plus MK3475 (Pembrolizumab) Versus Standard of Care for Patients Previously Treated with Immunotherapy for Stage IV or Recurrent Non-Small Cell Lung Cancer (Lung-MAP Non-Matched Sub-Study)
SWOG S1900A
Primary Category:
Treatment Protocols
Disease Category:
Lung, Lung - Non-Small Cell, Lung - Non-Small Cell Metastatic
A Phase II Study of Rucaparib in Patients with Genomic LOH High and/or Deleterious BRCA1/2 Mutation Stage IV or Recurrent Non-Small Cell Lung Cancer (LUNG-MAP Sub-Study)
NCT#03845296
(Click for More Info)
See Screening Protocol LUNGMAP
SWOG S1916
Primary Category:
Cancer Control and Prevention Protocols
Disease Category:
Brain, Breast, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Leukemia, Lung, Lymphoma, Multiple Myeloma, Neuroendocrine, Sarcoma, Skin, Thyroid
Status:
Upcoming - Pending IRB Review
Feasibility of a Digital Medicine Program in Optimizing Opioid Pain Control in Cancer Patients
Limited site participation. Open only to Billings Clinic.
Please see the SWOG website for any study documents not found here on the MCC website.
Lymphoma
AFT-28 CANVAS
Primary Category:
Cancer Control and Prevention Protocols
Disease Category:
Brain, Breast, Chronic Lymphocytic Leukemia, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Lung, Lymphoma, Melanoma, Multiple Myeloma, Neuroendocrine, Sarcoma
Direct Oral Anticoagulants (DOACs) versus LMWH +/- Warfarin for VTE in Cancer: A Randomized Effectiveness Trial (CANVAS Trial)
NCT#02744092
(Click for More Info)
Limited institution study – Only open to: Benefis Sletten Cancer Institute, Billings Clinic, Bozeman Health, Community Hospital of Anaconda, Community Medical Center, Kalispell Regional Medical Center, Kootenai Health, & Saint Alphonsus Regional Medical Center.
Sites must submit to MCC an AFT Delegation of Authority Log before any patient registrations may take place.
AFT-39 PROTECT
Primary Category:
Cancer Control and Prevention Protocols
Disease Category:
Anal, Bladder, Brain, Breast, Carcinoid, Cervical, Cholangiocarcinoma, Colon, Colon Metastatic, Endometrial, Esophageal, Gallbladder, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Liver, Lung, Lung - Non-Small Cell, Lung - Small Cell, Lymphoma, Melanoma, Multiple Myeloma, Neuroendocrine, Ovarian, Pancreatic, Prostate, Rectal, Renal, Sarcoma, Stomach, Thyroid, Uterine
Electronic patient reporting of symptoms during outpatient cancer treatment: A U.S. national randomized controlled trial (the “PRO-TECT” trial)
NCT#03249090
(Click for More Info)
Limited institution study – Only open to: Billings Clinic & Bozeman Health
Effective, October 25th, 2019, the CONTROL arm of AFT 39, is closed to accrual.
ALLIANCE A021602
Primary Category:
Treatment Protocols
Disease Category:
Carcinoid, Neuroendocrine, Pancreatic
Randomized, Double-Blinded Phase III Study of CABozantinib Versus Placebo IN Patients with Advanced NEuroendocrine Tumors After Progression on Everolimus (CABINET)
NCT#03375320
(Click for More Info)
Eligible for screening study DCP 001
ALLIANCE A051301
Primary Category:
Treatment Protocols
Disease Category:
Diffuse Large B-cell Lymphoma, Lymphoma, Non-Hodgkin Lymphoma
A Randomized Double-Blind Phase III Study of Ibrutinib During and Following Autologous Stem Cell Transplantation Versus Placebo in Patients with Relapsed or Refractory Diffuse Large B-cell Lymphoma of the Activated B-cell Subtype
Eligible for screening study DCP 001
NCT#02443077
(Click for More Info)
Site Delegation of Tasks Log required prior to registration of any patients.
ALLIANCE A051701
Primary Category:
Treatment Protocols
Disease Category:
Diffuse Large B-cell Lymphoma, Lymphoma, Non-Hodgkin Lymphoma
Randomized Phase II/III Study of Venetoclax (ABT199) Plus Chemoimmunotherapy for MYC/BCL2 Double-Hit and Double Expressing Lymphomas
NCT#03984448
(Click for More Info)
ALLIANCE C50904
Primary Category:
Treatment Protocols
Disease Category:
Follicular Lymphoma, Lymphoma, Non-Hodgkin Lymphoma
A Randomized Phase II Trial of Ofatumumab and Bendamustine VS. Ofatumumab, Bortezomib (NSC #681239, IND #58443) and Bendamustine in Patients with Untreated Follicular Lymphoma
(See Section 11.0 for required PET/CT credentialing.)
CALGB 50904 has met its accrual goal. Therefore, effective Tuesday, April 5, 2016 at 4:30 PM ET, CALGB 50904 will permanently close to new patient accrual.
NCT#01286272
(Click for More Info)
ECOG-ACRIN E1411
Primary Category:
Treatment Protocols
Disease Category:
Lymphoma, Mantle Cell Lymphoma, Non-Hodgkin Lymphoma
Intergroup Randomized Phase II Four Arm Study In Patients With Previously Untreated Mantle Cell Lymphoma Of Therapy With: Arm A = Rituximab+ Bendamustine Followed By Rituximab Consolidation (RB → R); Arm B = Rituximab + Bendamustine + Bortezomib Followed By Rituximab Consolidation (RBV→ R), Arm C = Rituximab + Bendamustine Followed By Lenalidomide + Rituximab Consolidation (RB → LR) or Arm D = Rituximab Bendamustine + Bortezomib Followed By Lenalidomide + Rituximab Consolidation (RBV → LR)
E1411 is successfully approaching its accrual goal, therefore this study will be closed to accrual effective September 9, 2016 at 5:00pm ET.
NCT#01415752
(Click for More Info)
ECOG-ACRIN E1412
Primary Category:
Treatment Protocols
Disease Category:
Diffuse Large B-cell Lymphoma, Lymphoma, Non-Hodgkin Lymphoma
Randomized Phase II Open Label Study of Lenalidomide R-CHOP (R2CHOP) vs RCHOP (Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone) in Patients with Newly Diagnosed Diffuse Large B Cell Lymphoma
E1412 is successfully approaching its accrual goal, therefore this study will be closed to Step 0 accrual effective January 17, 2017 at 5pm ET.
NCT#01856192
(Click for More Info)
ECOG-ACRIN E2408
Primary Category:
Treatment Protocols
Disease Category:
Follicular Lymphoma, Lymphoma
A 3-Arm Randomized Phase II Trial of Bendamustine-Rituximab (BR) Followed by Rituximab vs Bortezomib-BR (BVR) Followed by Rituximab vs BR Followed by Lenalidomide/Rituximab in High Risk Follicular Lymphoma
NCT#01216683
(Click for More Info)
ECOG-ACRIN E4412
Primary Category:
Treatment Protocols
Disease Category:
Hodgkin Lymphoma, Lymphoma
A Phase I Study with an Expansion Cohort/Randomized Phase II Study of the Combinations of Ipilimumab, Nivolumab and Brentuximab Vedotin in Patients with Relapsed/Refractory Hodgkin Lymphoma
NCT#01896999
(Click for More Info)
Open to Phase II accrual.
ECOG-ACRIN EA2161
Primary Category:
Treatment Protocols
Disease Category:
Carcinoid, Gastrointestinal, Neuroendocrine, Pancreatic
Status:
Temporarily Closed
A Phase II Study of MLN0128 (TAK-228) in Rapalog-Resistant Advanced Pancreatic Neuroendocrine Tumors (PNET)
Due to completion of accrual to the first stage, accrual to EA2161 is temporarily suspended effective 11/5/18. Only patients who have signed a consent to participate on or before 3:00 PM MST November 5, 2018 will be accepted. Consented patients must be registered on or before 3:00 PM MST November 12, 2018.
NCT#02893930
(Click for More Info)
ECOG-ACRIN EA4151
Primary Category:
Treatment Protocols
Disease Category:
Lymphoma, Mantle Cell Lymphoma, Non-Hodgkin Lymphoma
A Randomized Phase III Trial of Consolidation with Autologous Hematopoietic Cell Transplantation Followed by Maintenance Rituximab vs Maintenance Rituximab Alone for Patients with Mantle Cell Lymphoma in Minimal Residual Disease-Negative First Complete Remission
NCT#03267433
(Click for More Info)
Eligible for screening study DCP 001
ECOG-ACRIN EA4181
Primary Category:
Treatment Protocols
Disease Category:
Lymphoma, Mantle Cell Lymphoma, Non-Hodgkin Lymphoma
A Randomized 3-Arm Phase II Study Comparing 1.) Bendamustine, Rituximab and High Dose Cytarabine (BR/CR) 2.) Bendamustine, Rituximab, High Dose Cytarabine and Acalabrutinib (BR/CR-A), and 3.) Bendamustine, Rituximab and Acalabrutinib (BR-A) in Patients </= 70 Years Old With Untreated Mantle Cell Lymphoma
(Click for More Info)
ECOG-ACRIN EAQ152
Primary Category:
Cancer Control and Prevention Protocols
Disease Category:
Brain, Breast, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Lung, Lymphoma, Melanoma, Molecular Profiling, Other, Sarcoma
COMET – Communication and Education in Tumor Profiling: A Randomized Study of Pre-disclosure Genetic Education v. Usual Care in Tumor Profiling for Advanced Cancer and a Pilot Study of Remote Genetic Counseling for Participants with Potential Germline Mutations Identified on Tumor Profiling
(Sub-study for EAY131)
Eligible for screening study DCP 001
NCT#02823652
(Click for More Info)
MCC not eligible to participate in new addendum, as EAQ152 is only open to accrual at select sites.
ECOG-ACRIN EAY131
Primary Category:
Treatment Protocols
Disease Category:
Brain, Breast, Carcinoid, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Lung, Lymphoma, Melanoma, Molecular Profiling, Other, Sarcoma
Molecular Analysis for Therapy Choice (MATCH)
Eligible for screening study DCP 001
NCT#02465060
(Click for More Info)
The protocol allows designated private sector laboratories to refer patients to the study based on genetic testing performed independent of MATCH. This is limited to genetic testing ordered for patients at approved MATCH trial sites. Approved genetic testing laboratories and their date of inclusion in the outside assay process are:
- CARIS Life Sciences – 07/02/18
- CellNetix Pathology and Laboratories – 02/13/19
- Foundation Medicine – 07/02/18
- GenPath BioReference Laboratories – 08/03/18
- The Jackson Laboratory – 01/10/19
- NeoGenomics Laboratories – 07/02/18
- OmniSeq Laboratories – 07/16/18
- PathGroup – 10/29/18
- Quest Diagnostics Inc. – 05/20/19
- Strata Oncology – 08/03/18
- Tempus Laboratories – 07/16/18
The Biopsy consent form for this study is available upon request. Please contact Amber Boerner, aboerner@mtcancer.org or 406-969-6067, for the consent & for any questions.
(http://ecog-acrin.org/nci-match-eay131-designated-labs)
SWOG S1608
Primary Category:
Treatment Protocols
Disease Category:
Follicular Lymphoma, Lymphoma, Non-Hodgkin Lymphoma
Randomized Phase II Trial in Early Relapsing or Refractory Follicular Lymphoma
NCT#03269669
(Click for More Info)
SWOG S1826
Primary Category:
Radiation Oncology, Treatment Protocols
Disease Category:
Hodgkin Lymphoma, Lymphoma
A Phase III, Randomized Study of Nivolumab (Opdivo) Plus AVD or Brentuximab Vedotin (Adcetris) Plus AVD in Patients (Age >/= 12 Years) with Newly Diagnosed Advanced Stage Classical Hodgkin Lymphoma
NCT#03907488
Eligible for screening study DCP 001
(Click for More Info)
SWOG S1916
Primary Category:
Cancer Control and Prevention Protocols
Disease Category:
Brain, Breast, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Leukemia, Lung, Lymphoma, Multiple Myeloma, Neuroendocrine, Sarcoma, Skin, Thyroid
Status:
Upcoming - Pending IRB Review
Feasibility of a Digital Medicine Program in Optimizing Opioid Pain Control in Cancer Patients
Limited site participation. Open only to Billings Clinic.
Please see the SWOG website for any study documents not found here on the MCC website.
Molecular Profiling
ALLIANCE A071701
Primary Category:
Treatment Protocols
Disease Category:
Brain, Brain Metastatic, Molecular Profiling
Genomically-Guided Treatment Trial in Brain Metastases
(Click for More Info)
ALLIANCE A081105
Primary Category:
Treatment Protocols
Disease Category:
Lung, Lung - Non-Small Cell, Molecular Profiling
Randomized Double Blind Placebo Controlled Study of Erlotinib or Placebo in Patients with Completely Resected Epidermal Growth Factor Receptor (EGFR) Mutant Non-Small Cell Lung Cancer (NSCLC)
(See required screening study ALLIANCE A151216)
Eligible for screening study DCP 001
NCT#02193282
(Click for More Info)
ALLIANCE A151216
Primary Category:
Treatment Protocols
Disease Category:
Lung, Lung - Non-Small Cell, Molecular Profiling
Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial (ALCHEMIST)
A screening trial for A081105, E4512, and EA5142.
Eligible for screening study DCP 001
Effective, August 26, 2019, enrollment is temporarily suspended for patients with squamous histology.
NCT#02194738
(Click for More Info)
ECOG-ACRIN E4512
Primary Category:
Treatment Protocols
Disease Category:
Lung, Lung - Non-Small Cell, Molecular Profiling
A Phase III Double-Blind Trial for Surgically Resected Early Stage Non-Small Cell Lung Cancer: Crizotinib versus Placebo for Patients with Tumors Harboring the Anaplastic Lymphoma Kinase (ALK) Fusion Protein
(See required screening study ALLIANCE A151216)
Eligible for screening study DCP 001
NCT#02201992
(Click for More Info)
ECOG-ACRIN EA5142
Primary Category:
Treatment Protocols
Disease Category:
Lung, Lung - Non-Small Cell, Molecular Profiling
Adjuvant Nivolumab in Resected Lung Cancers (ANVIL)-A Randomized Phase III Study of Nivolumab After Surgical Resection and Adjuvant Chemotherapy in Non-Small Cell Lung Cancers
(See required screening study ALLIANCE A151216)
Eligible for screening study DCP 001
NCT#02595944
(Click for More Info)
Effective today, October 1st, 2019, study EA5142 has met accrual goals and is permanently closed to accrual.
This protocol has additional regulatory requirements to be completed prior to registering any patients at your site. Please contact Amber Boerner at 406-969-6067 or aboerner@mtcancer.org for additional information.
ECOG-ACRIN EAQ152
Primary Category:
Cancer Control and Prevention Protocols
Disease Category:
Brain, Breast, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Lung, Lymphoma, Melanoma, Molecular Profiling, Other, Sarcoma
COMET – Communication and Education in Tumor Profiling: A Randomized Study of Pre-disclosure Genetic Education v. Usual Care in Tumor Profiling for Advanced Cancer and a Pilot Study of Remote Genetic Counseling for Participants with Potential Germline Mutations Identified on Tumor Profiling
(Sub-study for EAY131)
Eligible for screening study DCP 001
NCT#02823652
(Click for More Info)
MCC not eligible to participate in new addendum, as EAQ152 is only open to accrual at select sites.
ECOG-ACRIN EAY131
Primary Category:
Treatment Protocols
Disease Category:
Brain, Breast, Carcinoid, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Lung, Lymphoma, Melanoma, Molecular Profiling, Other, Sarcoma
Molecular Analysis for Therapy Choice (MATCH)
Eligible for screening study DCP 001
NCT#02465060
(Click for More Info)
The protocol allows designated private sector laboratories to refer patients to the study based on genetic testing performed independent of MATCH. This is limited to genetic testing ordered for patients at approved MATCH trial sites. Approved genetic testing laboratories and their date of inclusion in the outside assay process are:
- CARIS Life Sciences – 07/02/18
- CellNetix Pathology and Laboratories – 02/13/19
- Foundation Medicine – 07/02/18
- GenPath BioReference Laboratories – 08/03/18
- The Jackson Laboratory – 01/10/19
- NeoGenomics Laboratories – 07/02/18
- OmniSeq Laboratories – 07/16/18
- PathGroup – 10/29/18
- Quest Diagnostics Inc. – 05/20/19
- Strata Oncology – 08/03/18
- Tempus Laboratories – 07/16/18
The Biopsy consent form for this study is available upon request. Please contact Amber Boerner, aboerner@mtcancer.org or 406-969-6067, for the consent & for any questions.
(http://ecog-acrin.org/nci-match-eay131-designated-labs)
ECOG-ACRIN EAY131-A
Primary Category:
Treatment Protocols
Disease Category:
Molecular Profiling
MATCH Treatment Subprotocol A: Phase II Trial of Afatinib in Patients with Solid Tumors (Other Than Small Cell and Non-Small Cell Lung Cancer) or Lymphomas, That Have Activating Mutations of EGFR and Have Progressed After Standard Treatment
(See required screening study ECOG-ACRIN EAY131)
Open to participants with results from one of the designated outside laboratories indicating a “rare variant that is an actionable Mutation of Interest (aMOI) for specific designated rare variant subprotocols. See Appendix XIV of the main protocol for a list of the designated laboratories and applicable subprotocols.
The consent form for this sub-study is available upon request when a patient at your site is assigned to the sub-study. Please contact Amber Boerner, aboerner@mtcancer.org or 406-969-6067, for the consent & for any questions.
NCT#02465060
(Click for More Info)
Protocol Eligibility & Calendar
ECOG-ACRIN EAY131-B
Primary Category:
Treatment Protocols
Disease Category:
Molecular Profiling
MATCH Treatment Subprotocol B: Phase II Study of Afatinib in Patients with Tumors with HER2 Activating Mutations
(See required screening study ECOG-ACRIN EAY131)
NCT#02465060
(Click for More Info)
Effective immediately, 06/15/18, EAY131-B is formally closed to accrual, as it has reached its enrollment goal.
ECOG-ACRIN EAY131-C1
Primary Category:
Treatment Protocols
Disease Category:
Molecular Profiling
Status:
Temporarily Closed
MATCH Treatment Subprotocol C1: Crizotinib in Patients with Tumors with MET Amplification
(See required screening study ECOG-ACRIN EAY131)
Open to participants with results from one of the designated outside laboratories indicating a “rare variant that is an actionable Mutation of Interest (aMOI) for specific designated rare variant subprotocols. See Appendix XIV of the main protocol for a list of the designated laboratories and applicable subprotocols.
The consent form for this sub-study is available upon request when a patient at your site is assigned to the sub-study. Please contact Amber Boerner, aboerner@mtcancer.org or 406-969-6067, for the consent & for any questions.
Due to the completion of accrual, all new assignments to this treatment arm will be suspended effective immediately, 06/19/18, until further notice.
NCT#02465060
(Click for More Info)
ECOG-ACRIN EAY131-C2
Primary Category:
Treatment Protocols
Disease Category:
Molecular Profiling
MATCH Treatment Subprotocol C2: Crizotinib in Patients with Tumors with MET Exon 14 Deletion
(See required screening study ECOG-ACRIN EAY131)
Open to participants with results from one of the designated outside laboratories indicating a “rare variant that is an actionable Mutation of Interest (aMOI) for specific designated rare variant subprotocols. See Appendix XIV of the main protocol for a list of the designated laboratories and applicable subprotocols.
The consent form for this sub-study is available upon request when a patient at your site is assigned to the sub-study. Please contact Amber Boerner, aboerner@mtcancer.org or 406-969-6067, for the consent & for any questions.
NCT#02465060
(Click for More Info)
ECOG-ACRIN EAY131-E
Primary Category:
Treatment Protocols
Disease Category:
Molecular Profiling
MATCH Treatment Subprotocol E: AZD9291 in Patients with Tumors Having EGFR T790M Mutations (Except Non-Small Cell Lung Cancer) or Rare Activating Mutations of EGFR
(See required screening study ECOG-ACRIN EAY131)
Open to participants with results from one of the designated outside laboratories indicating a “rare variant that is an actionable Mutation of Interest (aMOI) for specific designated rare variant subprotocols. See Appendix XIV of the main protocol for a list of the designated laboratories and applicable subprotocols.
The consent form for this sub-study is available upon request when a patient at your site is assigned to the sub-study. Please contact Amber Boerner, aboerner@mtcancer.org or 406-969-6067, for the consent & for any questions.
NCT#02465060
(Click for More Info)
ECOG-ACRIN EAY131-F
Primary Category:
Treatment Protocols
Disease Category:
Molecular Profiling
MATCH Treatment Subprotocol F: Crizotinib in Patients with Tumors (Other Than Adenocarcinoma of Lung or ALCL) with ALK Translocations
(See required screening study ECOG-ACRIN EAY131)
Due to the unexpectedly low prevalence of the associated targeted aberrations in our patient population, subprotocol EAY131-F is closed to accrual, effective May 16th, 2019 at 5:00 pm ET. No further treatment assignment to this subprotocol will be generated after this date, 05/16/19.
NCT#02465060
(Click for More Info)
ECOG-ACRIN EAY131-G
Primary Category:
Treatment Protocols
Disease Category:
Molecular Profiling
MATCH Treatment Subprotocol G: Phase II Study of Crizotinib in Patients with ROS1 Translocations (Other Than Patients with Non-Small Cell Lung Cancer)
(See required screening study ECOG-ACRIN EAY131)
Due to the unexpectedly low prevalence of the associated targeted aberrations in our patient population, subprotocol EAY131-G is closed to accrual, effective May 16th, 2019 at 5:00 pm ET. No further treatment assignment to this subprotocol will be generated after this date, 05/16/19.
NCT#02465060
(Click for More Info)
ECOG-ACRIN EAY131-H
Primary Category:
Treatment Protocols
Disease Category:
Molecular Profiling
MATCH Treatment Subprotocol H: Phase II Study of Dabrafenib and Trametinib in Patients with Tumors with BRAF V600E or V600K Mutations (Excluding Melanoma and Thyroid Cancer)
(See required screening study ECOG-ACRIN EAY131)
Effective immediately, 06/15/18, EAY131-H is formally closed to accrual, as it has reached its enrollment goal.
NCT#02465060
(Click for More Info)
ECOG-ACRIN EAY131-I
Primary Category:
Treatment Protocols
Disease Category:
Molecular Profiling
MATCH Treatment Subprotocol I: EAY131-I: GDC-0032 (taselisib) in Patients with Tumors (other than breast cancer) with PIK3CA mutation but without KRAS mutation or PTEN loss
(See required screening study ECOG-ACRIN EAY131)
NCT#02465060
(Click for More Info)
Effective immediately, 06/15/18, EAY131-I is formally closed to accrual, as it has reached its enrollment goal.
ECOG-ACRIN EAY131-J
Primary Category:
Treatment Protocols
Disease Category:
Molecular Profiling
Status:
Temporarily Closed
MATCH Treatment Subprotocol J: Trastuzumab and Pertuzumab (HP) in Patients with Non-Breast, Non-Gastric/GEJ Cancers with HER2 Amplification
(See required screening study ECOG-ACRIN EAY131)
The consent form for this sub-study is available upon request when a patient at your site is assigned to the sub-study. Please contact Amber Boerner, aboerner@mtcancer.org or 406-969-6067, for the consent & for any questions.
Effective June 14, 2019, sub-study EAY131-J is temporarily closed to accrual.
NCT#02465060
(Click for More Info)
ECOG-ACRIN EAY131-K1
Primary Category:
Treatment Protocols
Disease Category:
Molecular Profiling
MATCH Treatment Subprotocol K1: Phase 2 Study of Erdafitinib (JNJ-42756493) in Patients with Tumors with FGFR Amplifications
(See required screening study ECOG-ACRIN EAY131)
Open to participants with results from one of the designated outside laboratories indicating a “rare variant that is an actionable Mutation of Interest (aMOI) for specific designated rare variant subprotocols. See Appendix XIV of the main protocol for a list of the designated laboratories and applicable subprotocols.
The consent form for this sub-study is available upon request when a patient at your site is assigned to the sub-study. Please contact Amber Boerner, aboerner@mtcancer.org or 406-969-6067, for the consent & for any questions.
EAY131 (MATCH) Subprotocol K1, or EAY131-K1, has completed its accrual goal, and is temporarily suspended as of Tuesday, May 7th, 2019. No available treatment assignment slots remain at this time.
NCT#02465060
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ECOG-ACRIN EAY131-K2
Primary Category:
Treatment Protocols
Disease Category:
Molecular Profiling
MATCH Treatment Subprotocol K2: Phase 2 Study of Erdafitinib (JNJ-42756493) in Patients with Tumors with FGFR Mutations and Fusions
(See required screening study ECOG-ACRIN EAY131)
Open to participants with results from one of the designated outside laboratories indicating a “rare variant that is an actionable Mutation of Interest (aMOI) for specific designated rare variant subprotocols. See Appendix XIV of the main protocol for a list of the designated laboratories and applicable subprotocols.
The consent form for this sub-study is available upon request when a patient at your site is assigned to the sub-study. Please contact Amber Boerner, aboerner@mtcancer.org or 406-969-6067, for the consent & for any questions.
Effective today, July 18th, 2019, Subprotocol K2: Phase 2 is suspended due to the completion of accrual.
NCT#02465060
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ECOG-ACRIN EAY131-L
Primary Category:
Treatment Protocols
Disease Category:
Molecular Profiling
MATCH Treatment Subprotocol L: Phase II Study of MLN0128 (TAK-228) in Patients with Tumors with mTOR Mutations
(See required screening study ECOG-ACRIN EAY131)
Open to participants with results from one of the designated outside laboratories indicating a “rare variant that is an actionable Mutation of Interest (aMOI) for specific designated rare variant subprotocols. See Appendix XIV of the main protocol for a list of the designated laboratories and applicable subprotocols.
The consent form for this sub-study is available upon request when a patient at your site is assigned to the sub-study. Please contact Amber Boerner, aboerner@mtcancer.org or 406-969-6067, for the consent & for any questions.
NCT#02465060
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ECOG-ACRIN EAY131-M
Primary Category:
Treatment Protocols
Disease Category:
Molecular Profiling
Status:
Temporarily Closed
MATCH Treatment Subprotocol M: Phase II Study of MLN0128 (TAK-228) in Patients with Tumors with TSC1 or TSC2 Mutations
(See required screening study ECOG-ACRIN EAY131)
Open to participants with results from one of the designated outside laboratories indicating a “rare variant that is an actionable Mutation of Interest (aMOI) for specific designated rare variant subprotocols. See Appendix XIV of the main protocol for a list of the designated laboratories and applicable subprotocols.
The consent form for this sub-study is available upon request when a patient at your site is assigned to the sub-study. Please contact Amber Boerner, aboerner@mtcancer.org or 406-969-6067, for the consent & for any questions.
Effective immediately, May 20th, 2019, EAY131 Subprotocol M, is suspended due to the completion of accrual. *Patients who are currently being treated on Subprotocol M will continue on the study with no changes in the participation according to the Master Protocol and Subprotocol.
NCT#02465060
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ECOG-ACRIN EAY131-N
Primary Category:
Treatment Protocols
Disease Category:
Molecular Profiling
MATCH Treatment Subprotocol N: EAY131-N: Phase II Study of PI3K Beta Specific Inhibitor, GSK2636771, in Patients with Tumors with PTEN Mutation or Deletion, with PTEN Expression on IHC
(See required screening study ECOG-ACRIN EAY131)
Effective immediately, 06/15/18, EAY131-N is formally closed to accrual for administrative reasons.
NCT#02465060
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ECOG-ACRIN EAY131-P
Primary Category:
Treatment Protocols
Disease Category:
Molecular Profiling
MATCH Treatment Subprotocol P: EAY131-P: Phase II Study of PI3K Beta Specific Inhibitor, GSK2636771, in Patients with Tumors with PTEN Loss by IHC
(See required screening study ECOG-ACRIN EAY131)
NCT#02465060
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Effective immediately, 06/15/18, EAY131-P is formally closed to accrual, as it has reached its enrollment goal.
ECOG-ACRIN EAY131-Q
Primary Category:
Treatment Protocols
Disease Category:
Molecular Profiling
MATCH Treatment Subprotocol Q: Ado-trastuzumab Emtansine in Patients with Tumors with HER2 Amplification (Except Breast and Gastric/Gastro-Esophageal Junction (GEJ) Adenocarcinomas)
(See required screening study ECOG-ACRIN EAY131)
NCT#02465060
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Effective immediately, 06/15/18, EAY131-Q is formally closed to accrual, as it has reached its enrollment goal.
ECOG-ACRIN EAY131-R
Primary Category:
Treatment Protocols
Disease Category:
Molecular Profiling
MATCH Treatment Subprotocol R: Phase II Study of Trametinib in Patients with BRAF Fusions, or with Non-V600E, Non-V600K BRAF Mutations
(See required screening study ECOG-ACRIN EAY131)
NCT#02465060
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Effective immediately, 06/15/18, EAY131-R is formally closed to accrual, as it has reached its enrollment goal.
ECOG-ACRIN EAY131-S1
Primary Category:
Treatment Protocols
Disease Category:
Molecular Profiling
MATCH Treatment Subprotocol S1: EAY131-S1: Phase II Study of Trametinib in Patients with Tumors with NF1 mutations
(See required screening study ECOG-ACRIN EAY131)
NCT#02465060
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Effective immediately, 06/15/18, EAY131-S1 is formally closed to accrual, as it has reached its enrollment goal.
ECOG-ACRIN EAY131-S2
Primary Category:
Treatment Protocols
Disease Category:
Molecular Profiling
MATCH Treatment Subprotocol S2: EAY131-S2: Phase II Study of Trametinib in Patients with Tumors with GNAQ or GNA11 mutations
(See required screening study ECOG-ACRIN EAY131)
Due to the unexpectedly low prevalence of the associated targeted aberrations in our patient population, subprotocol EAY131-S2 is closed to accrual, effective May 16th, 2019 at 5:00 pm ET. No further treatment assignment to this subprotocol will be generated after this date, 05/16/19.
NCT#02465060
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ECOG-ACRIN EAY131-T
Primary Category:
Treatment Protocols
Disease Category:
Molecular Profiling
MATCH Treatment Subprotocol T: GDC-0449 (vismodegib) in Patients with Tumors (except basal cell skin carcinoma) with Smoothened (SMO) or Patched 1 (PTCH1) Mutations
(See required screening study ECOG-ACRIN EAY131)
Open to participants with results from one of the designated outside laboratories indicating a “rare variant that is an actionable Mutation of Interest (aMOI) for specific designated rare variant subprotocols. See Appendix XIV of the main protocol for a list of the designated laboratories and applicable subprotocols.
The consent form for this sub-study is available upon request when a patient at your site is assigned to the sub-study. Please contact Amber Boerner, aboerner@mtcancer.org or 406-969-6067, for the consent & for any questions.
NCT#02465060
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ECOG-ACRIN EAY131-U
Primary Category:
Treatment Protocols
Disease Category:
Molecular Profiling
MATCH Treatment Subprotocol U: VS-6063 (defactinib) in Patients with Tumors with NF2 Loss
(See required screening study ECOG-ACRIN EAY131)
NCT#02465060
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Effective immediately, 06/15/18, EAY131-U is formally closed to accrual, as it has reached its enrollment goal.
ECOG-ACRIN EAY131-V
Primary Category:
Treatment Protocols
Disease Category:
Molecular Profiling
MATCH Treatment Subprotocol V: Phase II Study of Sunitinib in Patients with Tumors with cKIT Mutations (Excluding GIST, Renal Cell Carcinoma or Pancreatic Neuroendocrine Tumor)
(See required screening study ECOG-ACRIN EAY131)
Open to participants with results from one of the designated outside laboratories indicating a “rare variant that is an actionable Mutation of Interest (aMOI) for specific designated rare variant subprotocols. See Appendix XIV of the main protocol for a list of the designated laboratories and applicable subprotocols.
The consent form for this sub-study is available upon request when a patient at your site is assigned to the sub-study. Please contact Amber Boerner, aboerner@mtcancer.org or 406-969-6067, for the consent & for any questions.
NCT#02465060
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ECOG-ACRIN EAY131-W
Primary Category:
Treatment Protocols
Disease Category:
Molecular Profiling
MATCH Treatment Subprotocol W: Phase II Study of AZD4547 in Patients with Tumors with Aberrations in the FGFR Pathway
(See required screening study ECOG-ACRIN EAY131)
NCT#02465060
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Effective immediately, 06/15/18, EAY131-W is formally closed to accrual, as it has reached its enrollment goal.
ECOG-ACRIN EAY131-X
Primary Category:
Treatment Protocols
Disease Category:
Molecular Profiling
MATCH Treatment Subprotocol X: EAY131-X: Phase II Study of Dasatinib in Patients with Tumors with DDR2 Mutations
(See required screening study ECOG-ACRIN EAY131)
Effective immediately, 06/15/18, EAY131-X is formally closed to accrual, as the prevalence rate for the mutation remains at zero.
NCT#02465060
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ECOG-ACRIN EAY131-Y
Primary Category:
Treatment Protocols
Disease Category:
Molecular Profiling
MATCH Treatment Subprotocol Y: AZD5363 in Patients with Tumors with AKT Mutations
(See required screening study ECOG-ACRIN EAY131)
NCT#02465060
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Effective immediately, 06/15/18, EAY131-Y is formally closed to accrual, as it has reached its enrollment goal.
ECOG-ACRIN EAY131-Z1A
Primary Category:
Treatment Protocols
Disease Category:
Molecular Profiling
MATCH Treatment Subprotocol Z1A: Binimetinib in Patients with Tumors (Other Than Melanoma) with NRAS Mutations
(See required screening study ECOG-ACRIN EAY131)
NCT#02465060
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Effective immediately, 06/15/18, EAY131-Z1A is formally closed to accrual, as it has reached its enrollment goal.
ECOG-ACRIN EAY131-Z1B
Primary Category:
Treatment Protocols
Disease Category:
Molecular Profiling
MATCH Treatment Subprotocol Z1B: Phase II Study of Palbociclib (PD-0332991) in Patients with Tumors with CCND1, 2, 3 Amplification and Rb Protein Expression by IHC
(See required screening study ECOG-ACRIN EAY131)
NCT#02465060
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Effective immediately, 06/15/18, EAY131-Z1B is formally closed to accrual, as it has reached its enrollment goal.
ECOG-ACRIN EAY131-Z1C
Primary Category:
Treatment Protocols
Disease Category:
Molecular Profiling
Status:
Temporarily Closed
MATCH Treatment Subprotocol Z1C: Phase II Study of Palbociclib (PD-0332991) in Patients with Tumors with CDK4 or CDK6 Amplification and Rb Protein Expression by IHC
(See required screening study ECOG-ACRIN EAY131)
EAY131 (MATCH) Subprotocol Z1C is suspended effective 10/18/18.
EAY131 (MATCH) Subprotocol Z1C is nearing the completion of its accrual goal, and only a limited number of available treatment assignment slots remain. 09/21/18
Open to participants with results from one of the designated outside laboratories indicating a “rare variant that is an actionable Mutation of Interest (aMOI) for specific designated rare variant subprotocols. See Appendix XIV of the main protocol for a list of the designated laboratories and applicable subprotocols.
The consent form for this sub-study is available upon request when a patient at your site is assigned to the sub-study. Please contact Amber Boerner, aboerner@mtcancer.org or 406-969-6067, for the consent & for any questions.
NCT#02465060
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ECOG-ACRIN EAY131-Z1D
Primary Category:
Treatment Protocols
Disease Category:
Molecular Profiling
MATCH Treatment Subprotocol Z1D: Nivolumab in Patients with Tumors with Mismatch Repair Deficiency (Excluding Colorectal Cancer)
(See required screening study ECOG-ACRIN EAY131)
NCT#02465060
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ECOG-ACRIN EAY131-Z1E
Primary Category:
Treatment Protocols
Disease Category:
Molecular Profiling
MATCH Treatment Subprotocol Z1E: LOXO-101 in Patients with Tumors with NTRK Fusions
(See required screening study ECOG-ACRIN EAY131)
Open to participants with results from one of the designated outside laboratories indicating a “rare variant that is an actionable Mutation of Interest (aMOI) for specific designated rare variant subprotocols. See Appendix XIV of the main protocol for a list of the designated laboratories and applicable subprotocols.
The consent form for this sub-study is available upon request when a patient at your site is assigned to the sub-study. Please contact Amber Boerner, aboerner@mtcancer.org or 406-969-6067, for the consent & for any questions.
NCT#02465060
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ECOG-ACRIN EAY131-Z1F
Primary Category:
Treatment Protocols
Disease Category:
Molecular Profiling
MATCH Treatment Subprotocol Z1F: Phase 2 Study of Copanlisib in Patients with Tumors with PIK3CA Mutations (PTEN Loss Allowed)
(See required screening study ECOG-ACRIN EAY131)
EAY131 (MATCH) Subprotocol Z1F, or EAY131-Z1F, is suspended, effective immediately, 12/27/18, due to the completion of accrual.
Open to participants with results from one of the designated outside laboratories indicating a “rare variant that is an actionable Mutation of Interest (aMOI) for specific designated rare variant subprotocols. See Appendix XIV of the main protocol for a list of the designated laboratories and applicable subprotocols.
The consent form for this sub-study is available upon request when a patient at your site is assigned to the sub-study. Please contact Amber Boerner, aboerner@mtcancer.org or 406-969-6067, for the consent & for any questions.
NCT#02465060
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ECOG-ACRIN EAY131-Z1G
Primary Category:
Treatment Protocols
Disease Category:
Molecular Profiling
MATCH Treatment Subprotocol Z1G: Phase 2 STudy of Copanlisib in Patients with Tumors with PTEN Loss by IHC and Any PTEN Sequencing Result
(See required screening study ECOG-ACRIN EAY131)
Open to participants with results from one of the designated outside laboratories indicating a “rare variant that is an actionable Mutation of Interest (aMOI) for specific designated rare variant subprotocols. See Appendix XIV of the main protocol for a list of the designated laboratories and applicable subprotocols.
The consent form for this sub-study is available upon request when a patient at your site is assigned to the sub-study. Please contact Amber Boerner, aboerner@mtcancer.org or 406-969-6067, for the consent & for any questions.
NCT#02465060
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ECOG-ACRIN EAY131-Z1H
Primary Category:
Treatment Protocols
Disease Category:
Molecular Profiling
MATCH Treatment Subprotocol Z1H: Phase 2 STudy of Copanlisib in Patients with Tumors with Deleterious PTEN Sequencing Result and PTEN Expression by IHC
(See required screening study ECOG-ACRIN EAY131)
Open to participants with results from one of the designated outside laboratories indicating a “rare variant that is an actionable Mutation of Interest (aMOI) for specific designated rare variant subprotocols. See Appendix XIV of the main protocol for a list of the designated laboratories and applicable subprotocols.
The consent form for this sub-study is available upon request when a patient at your site is assigned to the sub-study. Please contact Amber Boerner, aboerner@mtcancer.org or 406-969-6067, for the consent & for any questions.
NCT#02465060
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ECOG-ACRIN EAY131-Z1I
Primary Category:
Treatment Protocols
Disease Category:
Molecular Profiling
MATCH Treatment Subprotocol Z1I: Phase II Study of AZD1775 in Patients with Tumors Containing BRCA1 and BRCA2 Mutations
(See required screening study ECOG-ACRIN EAY131)
All new treatment assignments to EAY131 (MATCH) Subprotocol Z1I, EAY131-Z1I, are suspended effective immediately, 06/27/18,due to meeting it’s accrual goal.
The consent form for this sub-study is available upon request when a patient at your site is assigned to the sub-study. Please contact Amber Boerner, aboerner@mtcancer.org or 406-969-6067, for the consent & for any questions.
NCT#02465060
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ECOG-ACRIN EAY131-Z1K
Primary Category:
Treatment Protocols
Disease Category:
Molecular Profiling, Other
Molecular Analysis for Therapy Choice – Phase 2 Study of the Selective ATP-Competitive Inhibitor Ipatasertib (GDC-0068) in Patients with Tumors with AKT Mutation
(See required screening study ECOG-ACRIN EAY131)
Open to participants with results from one of the designated outside laboratories indicating a “rare variant that is an actionable Mutation of Interest (aMOI) for specific designated rare variant subprotocols. See Appendix XIV of the main protocol for a list of the designated laboratories and applicable subprotocols.
The consent form for this sub-study is available upon request when a patient at your site is assigned to the sub-study. Please contact Amber Boerner, aboerner@mtcancer.org or 406-969-6067, for the consent & for any questions.
NCT#02465060
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ECOG-ACRIN EAY131-Z1L
Primary Category:
Treatment Protocols
Disease Category:
Molecular Profiling, Other
Molecular Analysis for Therapy Choice – Phase 2 Study of BVD-523 (Ulixertinib) in Patients with Tumors with BRAF Fusions, or with Non-V600E, Non-V600K BRAF Mutations
(See required screening study ECOG-ACRIN EAY131)
Open to participants with results from one of the designated outside laboratories indicating a “rare variant that is an actionable Mutation of Interest (aMOI) for specific designated rare variant subprotocols. See Appendix XIV of the main protocol for a list of the designated laboratories and applicable subprotocols.
The consent form for this sub-study is available upon request when a patient at your site is assigned to the sub-study. Please contact Amber Boerner, aboerner@mtcancer.org or 406-969-6067, for the consent & for any questions.
NCT#02465060
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NCI 9671
Primary Category:
Cancer Control and Prevention Protocols
Disease Category:
Molecular Profiling, Other
Exceptional Responders Pilot study: Molecular profiling of tumors from cancer patients who are exceptional responders
All cases must be provisionally approved by NCI, before enrollment. Once a case is approved by NCI, then the IRB approval process takes place.
Due to the completion of accrual, new case proposal assignments to this protocol will be terminated July 10, 2017. As of July 11, 2017 no new case proposals will be accepted.
NCT#02243592
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SWOG S1400
Primary Category:
Treatment Protocols
Disease Category:
Lung, Lung - Non-Small Cell, Lung - Non-Small Cell Metastatic, Molecular Profiling
A Biomarker-Driven Master Protocol for Previously Treated Squamous Cell Lung Cancer
Eligible for screening study DCP 001
NCT#02154490
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Closure to accrual for S1400 will be effective 2:00 p.m. Pacific Time on January 28, 2019.
SWOG S1400A
Primary Category:
Treatment Protocols
Disease Category:
Lung, Lung - Non-Small Cell, Lung - Non-Small Cell Metastatic, Molecular Profiling
A Phase II Study of MEDI4736 for Previously Treated Patients with Stage IV Squamous Cell Lung Cancer and No Matching Biomarkers (Lung-MAP Sub-Study)
(See required screening study SWOG S1400)
Permanent Closure of S1400A, Arm 2-Docetaxel due to FDA approval of nivolumab. Permanent closure of sub-study due to a revised trial design.
NCT#02154490
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SWOG S1400B
Primary Category:
Treatment Protocols
Disease Category:
Lung, Lung - Non-Small Cell, Lung - Non-Small Cell Metastatic, Molecular Profiling
A Phase II Study of GDC-0032 (Taselisib) for Previously Treated PI3K Positive Patients with Stage IV Squamous Cell Lung Cancer (Lung-MAP Sub-Study)
(See required screening study SWOG S1400)
S1400B is closed to accrual effective December 12, 2016, as the study did not meet the criterion for the interim futility analysis.
NCT#02154490
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SWOG S1400C
Primary Category:
Treatment Protocols
Disease Category:
Lung, Lung - Non-Small Cell, Lung - Non-Small Cell Metastatic, Molecular Profiling
A Phase II Study of Palbociclib for Previously Treated Cell Cycle Gene Alteration Positive Patients with Stage IV Squamous Cell Lung Cancer (Lung-MAP Sub-Study)
(See required screening study SWOG S1400)
Permanent closure of Arm 2 ONLY due to a revised trial design.
S1400C will be permanently closed to accrual, effective September 1, 2016, as the study did not meet the criterion for the interim futility analysis.
NCT#02154490
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SWOG S1400D
Primary Category:
Treatment Protocols
Disease Category:
Lung, Lung - Non-Small Cell, Lung - Non-Small Cell Metastatic, Molecular Profiling
A Phase II Study of AZD4547 for Previously Treated FGFR-Positive Patients with Stage IV Squamous Cell Lung Cancer (Lung-MAP Sub-Study)
(See required screening study SWOG S1400)
Effective 11:59 p.m. Pacific Time on October 31, 2016, the following sub-study will be permanently closed to accrual, as the study did not meet the criterion for the interim futility analysis.
NCT#02154490
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SWOG S1400E
Primary Category:
Treatment Protocols
Disease Category:
Lung, Lung - Non-Small Cell, Lung - Non-Small Cell Metastatic, Molecular Profiling
A Phase II/III Randomized Study of Rilotumumab Plus Erlotinib Versus Erlotinib as Second Line Therapy for C-MET Positive Patients with Stage IV Squamous Cell Lung Cancer (Lung-Map Sub-Study)
(See required screening study SWOG S1400)
NCT#02154490
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SWOG S1400F
Primary Category:
Treatment Protocols
Disease Category:
Lung, Lung - Non-Small Cell, Lung - Non-Small Cell Metastatic, Molecular Profiling
A Phase II Study of MEDI4736 (Durvalumab) plus Tremelimumab as Therapy for Patients with Previously Treated ANTIPD-1/PD-L1 Resistant Stage IV Squamous Cell Lung Cancer (Lung-MAP Non-Match Sub-Study)
See Screening Protocol LUNGMAP
NCT#03373760
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Effective November 6th, 2019 at 2:00 pm Pacific Time, Cohort 1, the acquired resistance cohort of substudy S1400F will permanently close to accrual. Please note that Cohort 2, the primary resistance cohort, has been reactivated and is open to accrual.
SWOG S1400G
Primary Category:
Treatment Protocols
Disease Category:
Lung, Lung - Non-Small Cell, Lung - Non-Small Cell Metastatic, Molecular Profiling
A Phase II Study of Talazoparib (BMN 673) in Patients with Homologous Recombination Repair Deficiency Positive Stage IV Squamous Cell Lung Cancer (Lung-MAP Sub-Study)
(See required screening study SWOG S1400)
NCT#03377556
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Effective July 23, 2018, the following sub-study, S1400G, will be permanently closed.
SWOG S1400I
Primary Category:
Treatment Protocols
Disease Category:
Lung, Lung - Non-Small Cell, Lung - Non-Small Cell Metastatic, Molecular Profiling
A Phase III Randomized Study of Nivolumab Plus Ipilimumab Versus Nivolumab for Previously Treated Patients with Stage IV Squamous Cell Lung Cancer and No Matching Biomarker (Lung-MAP Sub-Study)
Eligible for screening study DCP 001
(See required screening study SWOG S1400)
NCT#02785952
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S1400I is permanently closed to accrual effective immediately, 04/23/18. At a planned interim analysis, SWOG’s Data and Safety Monitoring Committee recommended that sub study S1400I be permanently closed to accrual based on the results. This information will be shared and further instructions given in a forthcoming letter to patients and investigators. Patients currently receiving the experimental combination nivolumab plus ipilimumab may continue to receive treatment if the patient is deriving clinical benefit, the patient agrees to continue treatment, and if their physician feels that it is in the best interest of the patient to continue the treatment as an appropriate medical intervention at this time. Patients on both arms should continue study follow-up.
SWOG S1400K
Primary Category:
Treatment Protocols
Disease Category:
Lung, Lung - Non-Small Cell, Lung - Non-Small Cell Metastatic, Molecular Profiling
A Phase II Study of ABBV-399 (Process II) in Patients with
c-Met Positive Stage IV or Recurrent Squamous Cell Lung Cancer
(Lung-MAP Sub-Study)
S1400K will be temporarily closed to accrual 10/18/18 based on additional review of the safety data.
At a planned interim analysis, the study team reviewed patient data to date and did not find that every 3-week dosing of ABBV-399 was sufficiently active to continue enrolling patient to the study. S1400K will be permanently closed, on 12/21/18, to accrual based on the results.
(See required screening study SWOG S1400)
NCT#03574753
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SWOG S1609
Primary Category:
Treatment Protocols
Disease Category:
Molecular Profiling
Status:
Temporarily Closed
DART: Dual Anti-CTLA-4 and Anti-PD-1 Blockade in Rare Tumors
NCT#02834013
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Eligible for screening study DCP 001
Please see http://www.swogstat.org/accrual/dart.htm for up-to-date accrual information and current cohort accrual status (i.e. open, closed, suspended). The website is updated with the most current information daily.
As of today, November 5th, 2019, study S1609 (and all cohorts) is temporarily closed to accrual.
Multiple Myeloma
AFT-28 CANVAS
Primary Category:
Cancer Control and Prevention Protocols
Disease Category:
Brain, Breast, Chronic Lymphocytic Leukemia, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Lung, Lymphoma, Melanoma, Multiple Myeloma, Neuroendocrine, Sarcoma
Direct Oral Anticoagulants (DOACs) versus LMWH +/- Warfarin for VTE in Cancer: A Randomized Effectiveness Trial (CANVAS Trial)
NCT#02744092
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Limited institution study – Only open to: Benefis Sletten Cancer Institute, Billings Clinic, Bozeman Health, Community Hospital of Anaconda, Community Medical Center, Kalispell Regional Medical Center, Kootenai Health, & Saint Alphonsus Regional Medical Center.
Sites must submit to MCC an AFT Delegation of Authority Log before any patient registrations may take place.
AFT-39 PROTECT
Primary Category:
Cancer Control and Prevention Protocols
Disease Category:
Anal, Bladder, Brain, Breast, Carcinoid, Cervical, Cholangiocarcinoma, Colon, Colon Metastatic, Endometrial, Esophageal, Gallbladder, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Liver, Lung, Lung - Non-Small Cell, Lung - Small Cell, Lymphoma, Melanoma, Multiple Myeloma, Neuroendocrine, Ovarian, Pancreatic, Prostate, Rectal, Renal, Sarcoma, Stomach, Thyroid, Uterine
Electronic patient reporting of symptoms during outpatient cancer treatment: A U.S. national randomized controlled trial (the “PRO-TECT” trial)
NCT#03249090
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Limited institution study – Only open to: Billings Clinic & Bozeman Health
Effective, October 25th, 2019, the CONTROL arm of AFT 39, is closed to accrual.
ALLIANCE A011203
Primary Category:
Treatment Protocols
Disease Category:
Breast, Breast Metastatic
A Randomized Phase II Trial of Tamoxifen Versus Z-Endoxifen HCL in Postmenopausal Women with Metastatic Estrogen Receptor Positive, HER2 Negative Breast Cancer
NCT#02311933
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A011203 will soon meet its accrual goal. Therefore, EFFECTIVE MONDAY, April 17, 2017 at 4:30 pm ET, A011203 Pre-registration will permanently close to new patient accrual.
ALLIANCE A061402
Primary Category:
Cancer Control and Prevention Protocols, Treatment Protocols
Disease Category:
Multiple Myeloma, Other
Solitary Plasmacytoma of Bone: Randomized Phase III Trial to Evaluate Treatment with Adjuvant Systemic Treatment and Zoledronic Acid Versus Zoledronic Acid After Definite Radiation Therapy
Eligible for screening study DCP 001
NCT#02516423
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Effective IMMEDIATELY, August 15, 2019, Alliance A061402 will permanently close to new patient registration (Step 1).
ALLIANCE A171601
Primary Category:
Treatment Protocols
Disease Category:
Breast, Breast Metastatic
A Phase II Trial Assessing the Tolerability of Palbociclib in Combination with Letrozole or Fulvestrant in Patients Aged 70 and Older with Estrogen Receptor-Positive, HER2-Negative Metastatic Breast Cancer
NCT#03633331
(Click for More Info)
Eligible for screening study DCP 001
ECOG-ACRIN E1A11
Primary Category:
Treatment Protocols
Disease Category:
Multiple Myeloma
Randomized Phase III Trial of Bortezomib, LENalidomide and Dexamethasone (VRd) Versus Carfilzomib, Lenalidomide and Dexamethasone (CRd) Followed by Limited or Indefinite DURation Lenalidomide MaintenANCE in Patients with Newly Diagnosed Symptomatic Multiple Myeloma (ENDURANCE)
Eligible for screening study DCP 001
NCT#01863550
(Click for More Info)
E1A11 is successfully approaching its accrual goal. Therefore, this study will close to accrual effective January 29, 2019 at 5:00pm ET. Only patients who have signed a consent to participate on or before 5:00 PM (ET) January 29, 2019 will be accepted. Consented patients must be registered on or before 5:00 PM (ET) February 5, 2019.
ECOG-ACRIN E2108
Primary Category:
Treatment Protocols
Disease Category:
Breast, Breast Metastatic, Breast Neoadjuvant
A Randomized Phase III Trial of the Value of Early Local Therapy for the Intact Primary Tumor in Patients with Metastatic Breast Cancer
E2108 is approaching its accrual goal. Therefore, this study closed to accrual effective July 23, 2015 at 5:00 p.m. EDT for Step 1 registrations. Patients already registered to Step 1 may continue the process to Step 2 randomization, however no new Step 1 registrations will be permitted after this date.
NCT#01242800
(Click for More Info)
ECOG-ACRIN E3A06
Primary Category:
Treatment Protocols
Disease Category:
Multiple Myeloma
Randomized Phase III Trial of Lenalidomide Versus Observation Alone in Patients with Asymptomatic High-Risk Smoldering Multiple Myeloma
NCT#01169337
(Click for More Info)
E3A06 is successfully approaching its accrual goal. A pending closure date has been set for July 14, 2017 at 5:00pm ET for new patient registration.
ECOG-ACRIN EAA173
Primary Category:
Treatment Protocols
Disease Category:
Multiple Myeloma
Daratumumab to Enhance Therapeutic Effectiveness of Revlimid in Smoldering Myeloma (DETER-SMM)
Eligible for screening study DCP 001
(Click for More Info)
NCT#03937635
NRG BR002
Primary Category:
Radiation Oncology, Treatment Protocols
Disease Category:
Breast, Breast Metastatic
Status:
Temporarily Closed
A Phase IIR/III Trial of Standard of Care Therapy with or without Stereotactic Body Radiotherapy (SBRT) and/or Surgical Ablation for Newly Oligometastatic Breast Cancer
Effective, Friday, September 13th, 2019, study NRG BR002 is temporarily closed to accrual at 3 p.m. MST.
NCT#02364557
(Click for More Info)
NRG BR004
Primary Category:
Treatment Protocols
Disease Category:
Breast, Breast Metastatic
A Randomized, Double-Blind, Phase III Trial of Paclitaxel/Trastuzumab/Pertuzumab with Atezolizumab or Placebo in First-Line HER2-Positive Metastatic Breast Cancer
NCT#03199885
(Click for More Info)
SWOG S1304
Primary Category:
Treatment Protocols
Disease Category:
Multiple Myeloma
A Phase II Randomized Study Comparing Two Doses of Carfilzomib (NSC-756640) with Dexamethasone for Multiple Myeloma Patients with Relapsed or Refractory Disease
S1304 was temporarily closed to accrual on November 6, 2015. It was anticipated that the study would be re-opened to accrual (subsequent to an accrual target increase due to a higher than anticipated ineligibility rate). It has since been determined that the accrual target increase is not necessary for endpoint assessment. This study is now permanently closed to accrual, effective immediately.
NCT#01903811
(Click for More Info)
SWOG S1416
Primary Category:
Treatment Protocols
Disease Category:
Breast, Breast Metastatic
Phase II Randomized Placebo-Controlled Trial of Cisplatin with or Without ABT-888 (Veliparib) in Metastatic Triple-Negative Breast Cancer and/or BRCA Mutation-Associated Breast Cancer
NCT#02595905
(Click for More Info)
Effective, today, June 15th, 2019, SWOG S1416, is permanently closed to accrual.
SWOG S1501
Primary Category:
Cancer Control and Prevention Protocols
Disease Category:
Breast, Breast Metastatic
Prospective Evaluation of Carvedilol in Prevention of Cardiac Toxicity in Patients with Metastatic HER-2+ Breast Cancer, Phase III
Eligible for screening study DCP 001
NCT#03418961
(Click for More Info)
SWOG S1703
Primary Category:
Cancer Control and Prevention Protocols
Disease Category:
Breast, Breast Metastatic
Randomized Non-Inferiority Trial Comparing Overall Survival of Patients Monitored with Serum Tumor Marker Directed Disease Monitoring (STMDDM) versus Usual Care in Patients with Metastatic Hormone Receptor Positive Breast Cancer
NCT#03723928
(Click for More Info)
Eligible for screening study DCP 001
SWOG S1803
Primary Category:
Treatment Protocols
Disease Category:
Multiple Myeloma
Phase III Study of Daratumumab/rHuPH20 (NSC- 810307) + Lenalidomide or Lenalidomide as Post-Autologous Stem Cell Transplant Maintenance Therapy in Patients with Multiple Myeloma (MM) Using Minimal Residual Disease to Direct Therapy Duration (DRAMMATIC Study)
Eligible for screening study DCP 001
Occupational Report & Pregnancy Report consent forms available upon request. Please contact Amber Boerner, aboerner@mtcancer.org or 406-969-6067, for the consents and for any questions.
(Click for More Info)
SWOG S1916
Primary Category:
Cancer Control and Prevention Protocols
Disease Category:
Brain, Breast, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Leukemia, Lung, Lymphoma, Multiple Myeloma, Neuroendocrine, Sarcoma, Skin, Thyroid
Status:
Upcoming - Pending IRB Review
Feasibility of a Digital Medicine Program in Optimizing Opioid Pain Control in Cancer Patients
Limited site participation. Open only to Billings Clinic.
Please see the SWOG website for any study documents not found here on the MCC website.
Neuroendocrine
AFT-28 CANVAS
Primary Category:
Cancer Control and Prevention Protocols
Disease Category:
Brain, Breast, Chronic Lymphocytic Leukemia, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Lung, Lymphoma, Melanoma, Multiple Myeloma, Neuroendocrine, Sarcoma
Direct Oral Anticoagulants (DOACs) versus LMWH +/- Warfarin for VTE in Cancer: A Randomized Effectiveness Trial (CANVAS Trial)
NCT#02744092
(Click for More Info)
Limited institution study – Only open to: Benefis Sletten Cancer Institute, Billings Clinic, Bozeman Health, Community Hospital of Anaconda, Community Medical Center, Kalispell Regional Medical Center, Kootenai Health, & Saint Alphonsus Regional Medical Center.
Sites must submit to MCC an AFT Delegation of Authority Log before any patient registrations may take place.
AFT-39 PROTECT
Primary Category:
Cancer Control and Prevention Protocols
Disease Category:
Anal, Bladder, Brain, Breast, Carcinoid, Cervical, Cholangiocarcinoma, Colon, Colon Metastatic, Endometrial, Esophageal, Gallbladder, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Liver, Lung, Lung - Non-Small Cell, Lung - Small Cell, Lymphoma, Melanoma, Multiple Myeloma, Neuroendocrine, Ovarian, Pancreatic, Prostate, Rectal, Renal, Sarcoma, Stomach, Thyroid, Uterine
Electronic patient reporting of symptoms during outpatient cancer treatment: A U.S. national randomized controlled trial (the “PRO-TECT” trial)
NCT#03249090
(Click for More Info)
Limited institution study – Only open to: Billings Clinic & Bozeman Health
Effective, October 25th, 2019, the CONTROL arm of AFT 39, is closed to accrual.
ALLIANCE A021602
Primary Category:
Treatment Protocols
Disease Category:
Carcinoid, Neuroendocrine, Pancreatic
Randomized, Double-Blinded Phase III Study of CABozantinib Versus Placebo IN Patients with Advanced NEuroendocrine Tumors After Progression on Everolimus (CABINET)
NCT#03375320
(Click for More Info)
Eligible for screening study DCP 001
ALLIANCE A221701
Primary Category:
Cancer Control and Prevention Protocols
Disease Category:
Breast, Gastrointestinal, Genitourinary, Neuroendocrine, Pancreatic, Renal
Phase III Placebo-Controlled Trial to Evaluate Dexamethasone Use for Everolimus-Induced Oral Stomatitis: Prevention versus Early Treatment Approaches
NCT#03839940
(Click for More Info)
Eligible for screening study DCP 001
ECOG-ACRIN EA2142
Primary Category:
Treatment Protocols
Disease Category:
Gastrointestinal, Neuroendocrine
Randomized Phase II Study of Cisplatin and Etoposide versus Temozolomide and Capecitabine in Patients with Advanced G3 Non-Small Cell Gastroenteropancreatic Neuroendocrine Carcinomas
NCT#02595424
(Click for More Info)
ECOG-ACRIN EA2161
Primary Category:
Treatment Protocols
Disease Category:
Carcinoid, Gastrointestinal, Neuroendocrine, Pancreatic
Status:
Temporarily Closed
A Phase II Study of MLN0128 (TAK-228) in Rapalog-Resistant Advanced Pancreatic Neuroendocrine Tumors (PNET)
Due to completion of accrual to the first stage, accrual to EA2161 is temporarily suspended effective 11/5/18. Only patients who have signed a consent to participate on or before 3:00 PM MST November 5, 2018 will be accepted. Consented patients must be registered on or before 3:00 PM MST November 12, 2018.
NCT#02893930
(Click for More Info)
ECOG-ACRIN EAY131
Primary Category:
Treatment Protocols
Disease Category:
Brain, Breast, Carcinoid, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Lung, Lymphoma, Melanoma, Molecular Profiling, Other, Sarcoma
Molecular Analysis for Therapy Choice (MATCH)
Eligible for screening study DCP 001
NCT#02465060
(Click for More Info)
The protocol allows designated private sector laboratories to refer patients to the study based on genetic testing performed independent of MATCH. This is limited to genetic testing ordered for patients at approved MATCH trial sites. Approved genetic testing laboratories and their date of inclusion in the outside assay process are:
- CARIS Life Sciences – 07/02/18
- CellNetix Pathology and Laboratories – 02/13/19
- Foundation Medicine – 07/02/18
- GenPath BioReference Laboratories – 08/03/18
- The Jackson Laboratory – 01/10/19
- NeoGenomics Laboratories – 07/02/18
- OmniSeq Laboratories – 07/16/18
- PathGroup – 10/29/18
- Quest Diagnostics Inc. – 05/20/19
- Strata Oncology – 08/03/18
- Tempus Laboratories – 07/16/18
The Biopsy consent form for this study is available upon request. Please contact Amber Boerner, aboerner@mtcancer.org or 406-969-6067, for the consent & for any questions.
(http://ecog-acrin.org/nci-match-eay131-designated-labs)
SWOG S1614
Primary Category:
Cancer Control and Prevention Protocols
Disease Category:
Brain, Breast, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Lung, Neuroendocrine, Other, Sarcoma, Skin, Thyroid
A Phase III Randomized Trial of Prophylactic Antiviral Therapy in Patients with Current or Past Hepatitis B Virus (HBV) Infection Receiving Anti-Cancer Therapy for Solid Tumors
NCT#03887702
(Click for More Info)
SWOG S1916
Primary Category:
Cancer Control and Prevention Protocols
Disease Category:
Brain, Breast, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Leukemia, Lung, Lymphoma, Multiple Myeloma, Neuroendocrine, Sarcoma, Skin, Thyroid
Status:
Upcoming - Pending IRB Review
Feasibility of a Digital Medicine Program in Optimizing Opioid Pain Control in Cancer Patients
Limited site participation. Open only to Billings Clinic.
Please see the SWOG website for any study documents not found here on the MCC website.
Other
ALLIANCE A011106
Primary Category:
Treatment Protocols
Disease Category:
Breast, Breast Neoadjuvant
ALTernate approaches for clinical stage II or III Estrogen Receptor positive breast cancer NeoAdjuvant TrEatment (ALTERNATE) in postmenopausal women: A Phase III Study
Eligible for screening study DCP 001
NCT#01953588
(Click for More Info)
Effective today, July 15th, 2019, study A011106 is permanently closed to new patient registration.
ALLIANCE A011401
Primary Category:
Cancer Control and Prevention Protocols
Disease Category:
Adjuvant Breast, Breast, Breast Neoadjuvant
Randomized Phase III Trial Evaluating the Role of Weight Loss in Adjuvant Treatment of Overweight and Obese Women with Early Breast Cancer
Eligible for screening study DCP 001
NCT#02750826
(Click for More Info)
The A011401 Health Behaviors and Patient Reported Outcomes substudy HO1 will soon meet its study accrual goal. Therefore, EFFECTIVE July 06, 2017 at 4:30 pm ET, A011401 substudy HO1 will permanently close to new patient accrual.
ALLIANCE A061402
Primary Category:
Cancer Control and Prevention Protocols, Treatment Protocols
Disease Category:
Multiple Myeloma, Other
Solitary Plasmacytoma of Bone: Randomized Phase III Trial to Evaluate Treatment with Adjuvant Systemic Treatment and Zoledronic Acid Versus Zoledronic Acid After Definite Radiation Therapy
Eligible for screening study DCP 001
NCT#02516423
(Click for More Info)
Effective IMMEDIATELY, August 15, 2019, Alliance A061402 will permanently close to new patient registration (Step 1).
ALLIANCE A221602
Primary Category:
Cancer Control and Prevention Protocols
Olanzapine With or Without Fosaprepitant for the Prevention of Chemotherapy Induced Nausea and Vomiting (CINV)in Patients Receiving Highly Emetogenic Chemotherapy (HEC): A Phase III Randomized, Double Blind, Placebo-Controlled Trial
NCT#03578081
(Click for More Info)
Eligible for screening study DCP 001
DCP 001
Primary Category:
Cancer Control and Prevention Protocols
Use of a Clinical Trial Screening Tool to Address Cancer Health Disparities in the NCI Community Oncology Research Program (NCORP)
ECOG-ACRIN E2108
Primary Category:
Treatment Protocols
Disease Category:
Breast, Breast Metastatic, Breast Neoadjuvant
A Randomized Phase III Trial of the Value of Early Local Therapy for the Intact Primary Tumor in Patients with Metastatic Breast Cancer
E2108 is approaching its accrual goal. Therefore, this study closed to accrual effective July 23, 2015 at 5:00 p.m. EDT for Step 1 registrations. Patients already registered to Step 1 may continue the process to Step 2 randomization, however no new Step 1 registrations will be permitted after this date.
NCT#01242800
(Click for More Info)
ECOG-ACRIN EAQ152
Primary Category:
Cancer Control and Prevention Protocols
Disease Category:
Brain, Breast, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Lung, Lymphoma, Melanoma, Molecular Profiling, Other, Sarcoma
COMET – Communication and Education in Tumor Profiling: A Randomized Study of Pre-disclosure Genetic Education v. Usual Care in Tumor Profiling for Advanced Cancer and a Pilot Study of Remote Genetic Counseling for Participants with Potential Germline Mutations Identified on Tumor Profiling
(Sub-study for EAY131)
Eligible for screening study DCP 001
NCT#02823652
(Click for More Info)
MCC not eligible to participate in new addendum, as EAQ152 is only open to accrual at select sites.
ECOG-ACRIN EAY131
Primary Category:
Treatment Protocols
Disease Category:
Brain, Breast, Carcinoid, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Lung, Lymphoma, Melanoma, Molecular Profiling, Other, Sarcoma
Molecular Analysis for Therapy Choice (MATCH)
Eligible for screening study DCP 001
NCT#02465060
(Click for More Info)
The protocol allows designated private sector laboratories to refer patients to the study based on genetic testing performed independent of MATCH. This is limited to genetic testing ordered for patients at approved MATCH trial sites. Approved genetic testing laboratories and their date of inclusion in the outside assay process are:
- CARIS Life Sciences – 07/02/18
- CellNetix Pathology and Laboratories – 02/13/19
- Foundation Medicine – 07/02/18
- GenPath BioReference Laboratories – 08/03/18
- The Jackson Laboratory – 01/10/19
- NeoGenomics Laboratories – 07/02/18
- OmniSeq Laboratories – 07/16/18
- PathGroup – 10/29/18
- Quest Diagnostics Inc. – 05/20/19
- Strata Oncology – 08/03/18
- Tempus Laboratories – 07/16/18
The Biopsy consent form for this study is available upon request. Please contact Amber Boerner, aboerner@mtcancer.org or 406-969-6067, for the consent & for any questions.
(http://ecog-acrin.org/nci-match-eay131-designated-labs)
ECOG-ACRIN EAY131-Z1K
Primary Category:
Treatment Protocols
Disease Category:
Molecular Profiling, Other
Molecular Analysis for Therapy Choice – Phase 2 Study of the Selective ATP-Competitive Inhibitor Ipatasertib (GDC-0068) in Patients with Tumors with AKT Mutation
(See required screening study ECOG-ACRIN EAY131)
Open to participants with results from one of the designated outside laboratories indicating a “rare variant that is an actionable Mutation of Interest (aMOI) for specific designated rare variant subprotocols. See Appendix XIV of the main protocol for a list of the designated laboratories and applicable subprotocols.
The consent form for this sub-study is available upon request when a patient at your site is assigned to the sub-study. Please contact Amber Boerner, aboerner@mtcancer.org or 406-969-6067, for the consent & for any questions.
NCT#02465060
(Click for More Info)
ECOG-ACRIN EAY131-Z1L
Primary Category:
Treatment Protocols
Disease Category:
Molecular Profiling, Other
Molecular Analysis for Therapy Choice – Phase 2 Study of BVD-523 (Ulixertinib) in Patients with Tumors with BRAF Fusions, or with Non-V600E, Non-V600K BRAF Mutations
(See required screening study ECOG-ACRIN EAY131)
Open to participants with results from one of the designated outside laboratories indicating a “rare variant that is an actionable Mutation of Interest (aMOI) for specific designated rare variant subprotocols. See Appendix XIV of the main protocol for a list of the designated laboratories and applicable subprotocols.
The consent form for this sub-study is available upon request when a patient at your site is assigned to the sub-study. Please contact Amber Boerner, aboerner@mtcancer.org or 406-969-6067, for the consent & for any questions.
NCT#02465060
(Click for More Info)
NCI 9671
Primary Category:
Cancer Control and Prevention Protocols
Disease Category:
Molecular Profiling, Other
Exceptional Responders Pilot study: Molecular profiling of tumors from cancer patients who are exceptional responders
All cases must be provisionally approved by NCI, before enrollment. Once a case is approved by NCI, then the IRB approval process takes place.
Due to the completion of accrual, new case proposal assignments to this protocol will be terminated July 10, 2017. As of July 11, 2017 no new case proposals will be accepted.
NCT#02243592
(Click for More Info)
NRG B-51
Primary Category:
Radiation Oncology, Treatment Protocols
Disease Category:
Breast, Breast Neoadjuvant
Randomized Phase III Clinical Trial Evaluating Post-Mastectomy Chestwall and Regional Nodal XRT and Post-Lumpectomy Regional Nodal XRT in Patients with Positive Axillary Nodes Before Neoadjuvant Chemotherapy Who Convert to Pathologically Negative Axillary Nodes After Neoadjuvant Chemotherapy
Eligible for screening study DCP 001
NCT#01872975
(Click for More Info)
The accrual goal for the Behaviorial and Health Outcomes (BAHO) Quality of Life component in the B-51 trial has been met. Therefore, effective August 6th, 2018, accrual will be closed to the QoL component. The B-51 trial remains open to accrual.
NRG B-52
Primary Category:
Treatment Protocols
Disease Category:
Breast, Breast Neoadjuvant
A Randomized Phase III Trial Evaluating Pathologic Complete Response Rates in Patients with Hormone Receptor-Positive, HER2-Positive, Large Operable and Locally Advanced Breast Cancer Treated with Neoadjuvant Therapy of Docetaxel, Carboplatin, Trastuzumab, and Pertuzumab (TCHP) With or Without Estrogen Deprivation
B-52 will close to accrual, today, February 29, 2016, effective 8 pm EST. We realize that some patients who have consented to participate in the study will not have completed their pre-entry biopsy to obtain fresh tumor samples by today; therefore, patients who have signed the B-52 consent form on or before today, February 29, 2016, will be permitted to enter the study.
NCT#02003209
(Click for More Info)
NRG B-55
Primary Category:
Treatment Protocols
Disease Category:
Adjuvant Breast, Breast, Breast Neoadjuvant
A Randomised, Double-Blind, Parallel Group, Placebo-Controlled Multi-Centre Phase III Study to Assess the Efficacy and Safety of Olaparib Versus Placebo as Adjuvant Treatment in Patients with Germline BRCA1/2 Mutations and High Risk HER2 Negative Primary Breast Cancer Who Have Completed Definitive Local Treatment and Neoadjuvant or Adjuvant Chemotherapy
Eligible for screening study DCP 001
NCT#02032823
(Click for More Info)
Closure of Part 1 and Part 2 Screening will occur on April 1, 2019 at 5:00 PM Eastern Time. Accrual to the NSABP B-55/BIG 6-13 trial will close on April 29, 2019 at 5:00 PM Eastern Time. Patients, who are in screening, must be randomized to the study by 5:00 PM on April 29, 2019.
NRG BR005
Primary Category:
Treatment Protocols
Disease Category:
Breast, Breast Neoadjuvant
Status:
Temporarily Closed
A Phase II Trial Assessing the Accuracy of Tumor Bed Biopsies in Predicting Pathologic Response in Patients with Clinical/Radiologic Complete Response after Neoadjuvant Chemotherapy in Order to Explore the Feasibility of Breast Conserving Treatment without Surgery
NCT#03188393
Effective today, July 2, 2019, study NRG BR005 is temporarily closed to accrual.
(Click for More Info)
SWOG S1614
Primary Category:
Cancer Control and Prevention Protocols
Disease Category:
Brain, Breast, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Lung, Neuroendocrine, Other, Sarcoma, Skin, Thyroid
A Phase III Randomized Trial of Prophylactic Antiviral Therapy in Patients with Current or Past Hepatitis B Virus (HBV) Infection Receiving Anti-Cancer Therapy for Solid Tumors
NCT#03887702
(Click for More Info)
SWOG S1701
Primary Category:
Treatment Protocols
A Randomized Phase II Trial of Carboplatin-Paclitaxel with or Without Ramucirumab in Patients with Unresectable Locally Advanced, Recurrent, or Metastatic Thymic Carcinoma
NCT#03694002
(Click for More Info)
SWOG S1702
Primary Category:
Treatment Protocols
A Phase II Study of Isatuximab (SAR650984) for Patients with Previously Treated AL Amyloidosis
NCT#03499808
(Click for More Info)
Sarcoma
AFT-28 CANVAS
Primary Category:
Cancer Control and Prevention Protocols
Disease Category:
Brain, Breast, Chronic Lymphocytic Leukemia, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Lung, Lymphoma, Melanoma, Multiple Myeloma, Neuroendocrine, Sarcoma
Direct Oral Anticoagulants (DOACs) versus LMWH +/- Warfarin for VTE in Cancer: A Randomized Effectiveness Trial (CANVAS Trial)
NCT#02744092
(Click for More Info)
Limited institution study – Only open to: Benefis Sletten Cancer Institute, Billings Clinic, Bozeman Health, Community Hospital of Anaconda, Community Medical Center, Kalispell Regional Medical Center, Kootenai Health, & Saint Alphonsus Regional Medical Center.
Sites must submit to MCC an AFT Delegation of Authority Log before any patient registrations may take place.
AFT-39 PROTECT
Primary Category:
Cancer Control and Prevention Protocols
Disease Category:
Anal, Bladder, Brain, Breast, Carcinoid, Cervical, Cholangiocarcinoma, Colon, Colon Metastatic, Endometrial, Esophageal, Gallbladder, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Liver, Lung, Lung - Non-Small Cell, Lung - Small Cell, Lymphoma, Melanoma, Multiple Myeloma, Neuroendocrine, Ovarian, Pancreatic, Prostate, Rectal, Renal, Sarcoma, Stomach, Thyroid, Uterine
Electronic patient reporting of symptoms during outpatient cancer treatment: A U.S. national randomized controlled trial (the “PRO-TECT” trial)
NCT#03249090
(Click for More Info)
Limited institution study – Only open to: Billings Clinic & Bozeman Health
Effective, October 25th, 2019, the CONTROL arm of AFT 39, is closed to accrual.
ALLIANCE A091401
Primary Category:
Treatment Protocols
Disease Category:
Sarcoma
Randomized Phase II Study of Nivolumab with or Without Ipilimumab in Patients with Metastatic or Unresectable Sarcoma
NCT#02500797
(Click for More Info)
Effective Thursday, August 1, 2019, Alliance A091401 is permanently closed to new patient accrual.
ECOG-ACRIN EAQ152
Primary Category:
Cancer Control and Prevention Protocols
Disease Category:
Brain, Breast, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Lung, Lymphoma, Melanoma, Molecular Profiling, Other, Sarcoma
COMET – Communication and Education in Tumor Profiling: A Randomized Study of Pre-disclosure Genetic Education v. Usual Care in Tumor Profiling for Advanced Cancer and a Pilot Study of Remote Genetic Counseling for Participants with Potential Germline Mutations Identified on Tumor Profiling
(Sub-study for EAY131)
Eligible for screening study DCP 001
NCT#02823652
(Click for More Info)
MCC not eligible to participate in new addendum, as EAQ152 is only open to accrual at select sites.
ECOG-ACRIN EAY131
Primary Category:
Treatment Protocols
Disease Category:
Brain, Breast, Carcinoid, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Lung, Lymphoma, Melanoma, Molecular Profiling, Other, Sarcoma
Molecular Analysis for Therapy Choice (MATCH)
Eligible for screening study DCP 001
NCT#02465060
(Click for More Info)
The protocol allows designated private sector laboratories to refer patients to the study based on genetic testing performed independent of MATCH. This is limited to genetic testing ordered for patients at approved MATCH trial sites. Approved genetic testing laboratories and their date of inclusion in the outside assay process are:
- CARIS Life Sciences – 07/02/18
- CellNetix Pathology and Laboratories – 02/13/19
- Foundation Medicine – 07/02/18
- GenPath BioReference Laboratories – 08/03/18
- The Jackson Laboratory – 01/10/19
- NeoGenomics Laboratories – 07/02/18
- OmniSeq Laboratories – 07/16/18
- PathGroup – 10/29/18
- Quest Diagnostics Inc. – 05/20/19
- Strata Oncology – 08/03/18
- Tempus Laboratories – 07/16/18
The Biopsy consent form for this study is available upon request. Please contact Amber Boerner, aboerner@mtcancer.org or 406-969-6067, for the consent & for any questions.
(http://ecog-acrin.org/nci-match-eay131-designated-labs)
NRG DT001
Primary Category:
Radiation Oncology, Treatment Protocols
Disease Category:
Sarcoma
A Phase Ib Trial of Neoadjuvant AMG-232 Concurrent with Preoperative Radiotherapy in Wild-Type P53 Soft Tissue Sarcoma (STS)
NCT#03217266
(Click for More Info)
SWOG S1614
Primary Category:
Cancer Control and Prevention Protocols
Disease Category:
Brain, Breast, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Lung, Neuroendocrine, Other, Sarcoma, Skin, Thyroid
A Phase III Randomized Trial of Prophylactic Antiviral Therapy in Patients with Current or Past Hepatitis B Virus (HBV) Infection Receiving Anti-Cancer Therapy for Solid Tumors
NCT#03887702
(Click for More Info)
SWOG S1916
Primary Category:
Cancer Control and Prevention Protocols
Disease Category:
Brain, Breast, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Leukemia, Lung, Lymphoma, Multiple Myeloma, Neuroendocrine, Sarcoma, Skin, Thyroid
Status:
Upcoming - Pending IRB Review
Feasibility of a Digital Medicine Program in Optimizing Opioid Pain Control in Cancer Patients
Limited site participation. Open only to Billings Clinic.
Please see the SWOG website for any study documents not found here on the MCC website.
Skin
AFT-28 CANVAS
Primary Category:
Cancer Control and Prevention Protocols
Disease Category:
Brain, Breast, Chronic Lymphocytic Leukemia, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Lung, Lymphoma, Melanoma, Multiple Myeloma, Neuroendocrine, Sarcoma
Direct Oral Anticoagulants (DOACs) versus LMWH +/- Warfarin for VTE in Cancer: A Randomized Effectiveness Trial (CANVAS Trial)
NCT#02744092
(Click for More Info)
Limited institution study – Only open to: Benefis Sletten Cancer Institute, Billings Clinic, Bozeman Health, Community Hospital of Anaconda, Community Medical Center, Kalispell Regional Medical Center, Kootenai Health, & Saint Alphonsus Regional Medical Center.
Sites must submit to MCC an AFT Delegation of Authority Log before any patient registrations may take place.
AFT-39 PROTECT
Primary Category:
Cancer Control and Prevention Protocols
Disease Category:
Anal, Bladder, Brain, Breast, Carcinoid, Cervical, Cholangiocarcinoma, Colon, Colon Metastatic, Endometrial, Esophageal, Gallbladder, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Liver, Lung, Lung - Non-Small Cell, Lung - Small Cell, Lymphoma, Melanoma, Multiple Myeloma, Neuroendocrine, Ovarian, Pancreatic, Prostate, Rectal, Renal, Sarcoma, Stomach, Thyroid, Uterine
Electronic patient reporting of symptoms during outpatient cancer treatment: A U.S. national randomized controlled trial (the “PRO-TECT” trial)
NCT#03249090
(Click for More Info)
Limited institution study – Only open to: Billings Clinic & Bozeman Health
Effective, October 25th, 2019, the CONTROL arm of AFT 39, is closed to accrual.
ALLIANCE A091605
Primary Category:
Radiation Oncology, Treatment Protocols
A Randomized Phase II Study of Anti-PD1 Antibody [MK-3475 (Pembrolizumab)] Alone Versus Anti-PD1 Antibody Plus Stereotactic Body Radiation Therapy in Advanced Merkel Cell Carcinoma
NCT#03304639
(Click for More Info)
ALLIANCE A091802
Primary Category:
Treatment Protocols
Phase II Randomized Trial of Avelumab Plus Cetuximab Versus Avelumab Alone in Advanced Cutaneous Squamous Cell Carcinoma of the Skin (cSCC)
NCT#03944941
(Click for More Info)
ECOG-ACRIN E3612
Primary Category:
Treatment Protocols
Disease Category:
Melanoma, Metastatic Melanoma, Skin
A Randomized Phase II Trial of Ipilimumab with or without Bevacizumab in Patients with Unresectable Stage III or Stage IV Melanoma
NCT#01950390
(Click for More Info)
E3612 has successfully reached its accrual goal. Therefore, E3612 will close to accrual on September 25, 2017 effective at 5:00 p.m. ET for registrations.
ECOG-ACRIN EA6134
Primary Category:
Treatment Protocols
Disease Category:
Melanoma, Metastatic Melanoma, Skin
DREAMseq (Doublet, Randomized Evaluation in Advanced Melanoma Sequencing) a Phase III Trial
Eligible for screening study DCP 001
NCT#02224781
(Click for More Info)
ECOG-ACRIN EA6141
Primary Category:
Treatment Protocols
Disease Category:
Melanoma, Metastatic Melanoma, Skin
Status:
Temporarily Closed
Randomized Phase II/III Study of Nivolumab plus Ipilimumab plus Sargramostim versus Nivolumab plus Ipilimumab in Patients with Unresectable Stage III or Stage IV Melanoma
NCT#02339571
(Click for More Info)
Enrollment is on target to reach the accrual goal necessary to conduct a study-specified planned interim analysis per section 9.4 of the protocol. Only patients who have signed a consent to participate on or before 5:00 PM (EST) June 23rd, and for whom registration is completed by 5:00 PM (EST) June 30th, will be accepted, until further notice.
This protocol has additional training requirements to be completed prior to registering any patients at your site. Please contact Amber Boerner at 406-969-6067 or aboerner@mtcancer.org for additional information.
ECOG-ACRIN EA6174
Primary Category:
Treatment Protocols
A Phase III Randomized Trial Comparing Adjuvant MK-3475 (Pembrolizumab) to Standard of Care Observation in Completely Resected Merkel Cell Carcinoma
NCT#03712605
(Click for More Info)
Eligible for screening study DCP 001
ECOG-ACRIN EAQ152
Primary Category:
Cancer Control and Prevention Protocols
Disease Category:
Brain, Breast, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Lung, Lymphoma, Melanoma, Molecular Profiling, Other, Sarcoma
COMET – Communication and Education in Tumor Profiling: A Randomized Study of Pre-disclosure Genetic Education v. Usual Care in Tumor Profiling for Advanced Cancer and a Pilot Study of Remote Genetic Counseling for Participants with Potential Germline Mutations Identified on Tumor Profiling
(Sub-study for EAY131)
Eligible for screening study DCP 001
NCT#02823652
(Click for More Info)
MCC not eligible to participate in new addendum, as EAQ152 is only open to accrual at select sites.
ECOG-ACRIN EAY131
Primary Category:
Treatment Protocols
Disease Category:
Brain, Breast, Carcinoid, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Lung, Lymphoma, Melanoma, Molecular Profiling, Other, Sarcoma
Molecular Analysis for Therapy Choice (MATCH)
Eligible for screening study DCP 001
NCT#02465060
(Click for More Info)
The protocol allows designated private sector laboratories to refer patients to the study based on genetic testing performed independent of MATCH. This is limited to genetic testing ordered for patients at approved MATCH trial sites. Approved genetic testing laboratories and their date of inclusion in the outside assay process are:
- CARIS Life Sciences – 07/02/18
- CellNetix Pathology and Laboratories – 02/13/19
- Foundation Medicine – 07/02/18
- GenPath BioReference Laboratories – 08/03/18
- The Jackson Laboratory – 01/10/19
- NeoGenomics Laboratories – 07/02/18
- OmniSeq Laboratories – 07/16/18
- PathGroup – 10/29/18
- Quest Diagnostics Inc. – 05/20/19
- Strata Oncology – 08/03/18
- Tempus Laboratories – 07/16/18
The Biopsy consent form for this study is available upon request. Please contact Amber Boerner, aboerner@mtcancer.org or 406-969-6067, for the consent & for any questions.
(http://ecog-acrin.org/nci-match-eay131-designated-labs)
SWOG S1404
Primary Category:
Treatment Protocols
Disease Category:
Melanoma, Skin
A Phase III Randomized Trial Comparing Physician/Patient Choice of High Dose Interferon or Ipilimumab to MK-3475 (Pembrolizumab) in Patients with High Risk Resected Melanoma
Eligible for screening study DCP 001
NCT#02506153
(Click for More Info)
Step 1 (prestudy screening) of S1404 study has reached its accrual goal and will be permanently closed to accrual effective August 15, 2017 at 11:59 p.m. Pacific Time.
Step 2 (randomization) of S1404 will be permanently closed to accrual effective November 2, 2017 at 11:59 p.m. Pacific Time.
SWOG S1512
Primary Category:
Treatment Protocols
Disease Category:
Melanoma, Skin
A Phase II and Pilot Trial of PD-1 Blockade with MK-3475 (Pembrolizumab) in Patients with Resectable or Unresectable Desmoplastic Melanoma (DM)
NCT#02775851
(Click for More Info)
SWOG S1607
Primary Category:
Treatment Protocols
Disease Category:
Melanoma, Metastatic Melanoma, Skin
A Phase II Study of Combining T-VEC (NSC-785349) and Pembrolizumab (NSC-776864) in Patients with Advanced Melanoma Who Have Progressed on Anti-PD1/L1 Based Therapy
NCT#02965716
(Click for More Info)
Limited institution study: open only to Billings Clinic
SWOG S1614
Primary Category:
Cancer Control and Prevention Protocols
Disease Category:
Brain, Breast, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Lung, Neuroendocrine, Other, Sarcoma, Skin, Thyroid
A Phase III Randomized Trial of Prophylactic Antiviral Therapy in Patients with Current or Past Hepatitis B Virus (HBV) Infection Receiving Anti-Cancer Therapy for Solid Tumors
NCT#03887702
(Click for More Info)
SWOG S1616
Primary Category:
Treatment Protocols
Disease Category:
Melanoma, Metastatic Melanoma, Skin
A Phase II Randomized Study of Nivolumab (NSC-748726) with Ipilimumab (NSC-732442) OR Ipilimumab Alone in Advanced Melanoma Patients Refractory to an Anti-PD-1 or Anti PD-L1 Agent
NCT#03033576
(Click for More Info)
SWOG S1801
Primary Category:
Treatment Protocols
Disease Category:
Melanoma, Metastatic Melanoma, Skin
A Phase II Randomized Study of Adjuvant Versus NeoAdjuvant MK-3475 (Pembrolizumab) for Clinically Detectable Stage III-IV High-Risk Melanoma
NCT#03698019
(Click for More Info)
SWOG S1916
Primary Category:
Cancer Control and Prevention Protocols
Disease Category:
Brain, Breast, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Leukemia, Lung, Lymphoma, Multiple Myeloma, Neuroendocrine, Sarcoma, Skin, Thyroid
Status:
Upcoming - Pending IRB Review
Feasibility of a Digital Medicine Program in Optimizing Opioid Pain Control in Cancer Patients
Limited site participation. Open only to Billings Clinic.
Please see the SWOG website for any study documents not found here on the MCC website.
Thyroid
AFT-39 PROTECT
Primary Category:
Cancer Control and Prevention Protocols
Disease Category:
Anal, Bladder, Brain, Breast, Carcinoid, Cervical, Cholangiocarcinoma, Colon, Colon Metastatic, Endometrial, Esophageal, Gallbladder, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Liver, Lung, Lung - Non-Small Cell, Lung - Small Cell, Lymphoma, Melanoma, Multiple Myeloma, Neuroendocrine, Ovarian, Pancreatic, Prostate, Rectal, Renal, Sarcoma, Stomach, Thyroid, Uterine
Electronic patient reporting of symptoms during outpatient cancer treatment: A U.S. national randomized controlled trial (the “PRO-TECT” trial)
NCT#03249090
(Click for More Info)
Limited institution study – Only open to: Billings Clinic & Bozeman Health
Effective, October 25th, 2019, the CONTROL arm of AFT 39, is closed to accrual.
ALLIANCE A091305
Primary Category:
Treatment Protocols
Disease Category:
Thyroid
A Phase 2 Study of Efatutazone, an Oral PPAR Agonist, In Combination with Paclitaxel in Patients with Advanced Anaplastic Thyroid Cancer
NCT#02152137
(Click for More Info)
SWOG S1614
Primary Category:
Cancer Control and Prevention Protocols
Disease Category:
Brain, Breast, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Lung, Neuroendocrine, Other, Sarcoma, Skin, Thyroid
A Phase III Randomized Trial of Prophylactic Antiviral Therapy in Patients with Current or Past Hepatitis B Virus (HBV) Infection Receiving Anti-Cancer Therapy for Solid Tumors
NCT#03887702
(Click for More Info)
SWOG S1916
Primary Category:
Cancer Control and Prevention Protocols
Disease Category:
Brain, Breast, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Leukemia, Lung, Lymphoma, Multiple Myeloma, Neuroendocrine, Sarcoma, Skin, Thyroid
Status:
Upcoming - Pending IRB Review
Feasibility of a Digital Medicine Program in Optimizing Opioid Pain Control in Cancer Patients
Limited site participation. Open only to Billings Clinic.
Please see the SWOG website for any study documents not found here on the MCC website.
