Search and Filter Protocols

Use the checkboxes and search input field to locate the relevant protocol.

To filter by categories, simply select the relevant categories and/or statuses and click "submit" (without entering any text into the search field).

To search by Protocol name, simply enter it into the search box and click "submit".

  • Primary Categories

  • Disease Categories

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*NOTE* if there are categories that have no protocols attached, they will not show up as a checkbox for filtering. For example, if "Head and Neck" is not available as a disease category checkbox selection, there are no protocols that have that disease category assigned.

All Current Protocols Arranged Alphabetically by Disease Category:

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

Status:

Open

Direct Oral Anticoagulants (DOACs) versus LMWH +/- Warfarin for VTE in Cancer: A Randomized Effectiveness Trial (CANVAS Trial)

NCT#02744092

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

Status:

Open

Electronic patient reporting of symptoms during outpatient cancer treatment: A U.S. national randomized controlled trial (the “PRO-TECT” trial)

NCT#03249090

Limited institution study – Only open to:  Billings Clinic & Bozeman Health

ALLIANCE A071102

Primary Category:

Treatment Protocols

Disease Category:

Brain

Status:

Closed

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

ALLIANCE A071401

Primary Category:

Treatment Protocols

Disease Category:

Brain

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

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

Disease Category:

Brain

Status:

Open

Phase II Trial of BRAF/MEK Inhibitors in Papillary Craniopharyngiomas

 

NCT#03224767

ALLIANCE A221208

Primary Category:

Cancer Control and Prevention Protocols, Radiation Oncology

Disease Category:

Brain Metastatic

Status:

Closed

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

ALLIANCE CCTG CE.7

Primary Category:

Radiation Oncology

Disease Category:

Brain, Brain Metastatic

Status:

Temporarily Closed

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

Enrollment of new patients to this study has been temporarily suspended effective immediately, 03/08/19, pending protocol amendment. Based on preliminary results of the NRG-CC001 study, presented at the 2018 Annual Meeting of the American Society for Radiation Oncology (ASTRO) and during the plenary session of the 2018 Annual Meeting of the Society for Neuro-Oncology (SNO), an amendment has been submitted to CTEP revising the WBRT control arm of the CE.7 trial to incorporate hippocampal avoidance. Accrual will resume upon approval and activation of the amendment.

ALLIANCE N0577

Primary Category:

Radiation Oncology, Treatment Protocols

Disease Category:

Brain

Status:

Open

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

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

Status:

Closed

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

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

Status:

Open

Molecular Analysis for Therapy Choice (MATCH)

Eligible for screening study DCP 001

NCT#02465060

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

(http://ecog-acrin.org/nci-match-eay131-designated-labs)

NRG BN003

Primary Category:

Radiation Oncology, Treatment Protocols

Disease Category:

Brain

Status:

Open

Phase III Trial of Observation Versus Irradiation for a Gross Totally Resected Grade II Meningioma

Eligible for screening study DCP 001

NCT#03180268

NRG CC001

Primary Category:

Radiation Oncology, Treatment Protocols

Disease Category:

Brain

Status:

Closed

A Randomized Phase III Trial of Memantine and Whole-Brain Radiotherapy With or Without Hippocampal Avoidance in Patients With Brain Metastases

NCT#02360215

Eligible for screening study DCP 001

CC001 will close to accrual at 5 PM ET Monday, March 12, 2018, because it is has reached its accrual target. All patients registered to Step 1 registration by March 12 will be permitted to proceed to the randomization step (Step 2).

 

NRG CC003

Primary Category:

Radiation Oncology

Disease Category:

Brain, Lung, Lung - Small Cell, Lung - Small Cell Extensive Stage, Lung - Small Cell Limited Stage

Status:

Open

Randomized Phase II/III Trial of Prophylatic Cranial Irradiation With or Without Hippocampal Avoidance for Small Cell Lung Cancer

NCT#02635009

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

Status:

New, Open

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

Breast

AFT-25 COMET

Primary Category:

Radiation Oncology, Surgical Protocols, Treatment Protocols

Disease Category:

Breast, Breast DCIS

Status:

Open

Comparison of Operative to Monitoring and Endocrine Therapy (COMET) Trial For Low Risk DCIS: A Phase III Prospective Randomized Trial

NCT#02926911

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-27 IMPASSION

Primary Category:

Treatment Protocols

Disease Category:

Adjuvant Breast, Breast

Status:

Open

A Phase III, Multicenter, Randomized, Open-Label Study Comparing Atezolizumab (Anti PD-L1 Antibody) in Combination With Adjuvant Anthracycline/Taxane-Based Chemotherapy Versus Chemotherapy Alone in Patients With Operable Triple Negative Breast Cancer

NCT#03498716

Limited institution study – Only open to:  Billings Clinic

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

Status:

Open

Direct Oral Anticoagulants (DOACs) versus LMWH +/- Warfarin for VTE in Cancer: A Randomized Effectiveness Trial (CANVAS Trial)

NCT#02744092

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

Status:

Open

Electronic patient reporting of symptoms during outpatient cancer treatment: A U.S. national randomized controlled trial (the “PRO-TECT” trial)

NCT#03249090

Limited institution study – Only open to:  Billings Clinic & Bozeman Health

ALLIANCE A011106

Primary Category:

Treatment Protocols

Disease Category:

Breast, Breast Neoadjuvant

Status:

Closed

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

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

ALLIANCE A011203

Primary Category:

Treatment Protocols

Disease Category:

Breast, Breast Metastatic

Status:

Closed

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

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

Status:

Open

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

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

Status:

Open

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

ALLIANCE A171601

Primary Category:

Treatment Protocols

Disease Category:

Breast, Breast Metastatic

Status:

New, Open

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

Eligible for screening study DCP 001

ALLIANCE A211601

Primary Category:

Cancer Control and Prevention Protocols

Disease Category:

Adjuvant Breast, Breast

Status:

New, Open

Evaluation of Mammographic Breast Density Effect of Aspirin: A Companion to Alliance Study A011502

NCT#03609021

Eligible for screening study DCP 001

ALLIANCE A221405

Primary Category:

Cancer Control and Prevention Protocols, Treatment Protocols

Disease Category:

Adjuvant Breast, Breast

Status:

Open

Pregnancy Outcome and Safety of Interrupting Therapy for women with endocrine responsIVE breast cancer

NCT#02308085

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

Status:

Open

Phase III Randomized Trial of Hypofractionated Post Mastectomy Radiation with Breast Reconstruction

NCT#03414970

Eligible for screening study DCP 001

ALLIANCE A221701

Primary Category:

Cancer Control and Prevention Protocols

Disease Category:

Breast, Gastrointestinal, Genitourinary, Neuroendocrine, Pancreatic, Renal

Status:

New, Open

Phase III Placebo-Controlled Trial to Evaluate Dexamethasone Use for Everolimus-Induced Oral Stomatitis: Prevention versus Early Treatment Approaches

NCT#03839940

Eligible for screening study DCP 001

ALLIANCE A231701CD

Primary Category:

Cancer Care Delivery, Surgical Protocols

Disease Category:

Breast, Cancer Care Delivery

Status:

New, Open

Increasing Socioeconomically Disadvantaged Patients’ Engagement in Breast Cancer Surgery Decision Making Through a Shared Decision Making Intervention

NCT#03766009

Limited institution study – Only open to:  Billings Clinic

ALLIANCE Z11102

Primary Category:

Surgical Protocols

Disease Category:

Breast

Status:

Closed

Impact of Breast Conservation Surgery on Surgical Outcomes and Cosmesis in Patients with Multiple Ipsilateral Breast Cancers (MIBC)

NCT#01556243

ECOG-ACRIN E2108

Primary Category:

Treatment Protocols

Disease Category:

Breast, Breast Metastatic, Breast Neoadjuvant

Status:

Closed

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

ECOG-ACRIN E5103

Primary Category:

Treatment Protocols

Disease Category:

Adjuvant Breast, Breast

Status:

Closed

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

ECOG-ACRIN EA1131

Primary Category:

Treatment Protocols

Disease Category:

Adjuvant Breast, Breast

Status:

Open

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

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

Status:

Closed

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

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

Status:

Open

Molecular Analysis for Therapy Choice (MATCH)

Eligible for screening study DCP 001

NCT#02465060

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

(http://ecog-acrin.org/nci-match-eay131-designated-labs)

ECOG-ACRIN PACCT-1

Primary Category:

Treatment Protocols

Disease Category:

Adjuvant Breast, Breast

Status:

Closed

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

NRG B-51

Primary Category:

Radiation Oncology, Treatment Protocols

Disease Category:

Breast, Breast Neoadjuvant

Status:

Open

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

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

Status:

Closed

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

NRG B-55

Primary Category:

Treatment Protocols

Disease Category:

Adjuvant Breast, Breast, Breast Neoadjuvant

Status:

Closed

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

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:

Open

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

NCT#02364557

NRG BR003

Primary Category:

Treatment Protocols

Disease Category:

Adjuvant Breast, Breast

Status:

Open

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

NRG BR004

Primary Category:

Treatment Protocols

Disease Category:

Breast, Breast Metastatic

Status:

New, Open

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

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.

NRG CC004

Primary Category:

Cancer Control and Prevention Protocols

Disease Category:

Breast, Gynecologic

Status:

Open

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

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

Status:

New, Open

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

SWOG S1007

Primary Category:

Treatment Protocols

Disease Category:

Adjuvant Breast, Breast

Status:

Closed

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

SWOG S1207

Primary Category:

Treatment Protocols

Disease Category:

Adjuvant Breast, Breast

Status:

Closed

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

Eligible for screening study DCP 001

SWOG S1416

Primary Category:

Treatment Protocols

Disease Category:

Breast, Breast Metastatic

Status:

Closed

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

S1416 has an accrual goal of 235 in the main cohort and 98 in the brain metastases cohort for a total of 333 patients. The main cohort was reactivated on July 18, 2018. The brain metastases cohort will remain open. The overall accrual target for S1416 has not changed.

Effective, today, June 15th, 2019, SWOG S1416, is permanently closed to accrual.

SWOG S1418

Primary Category:

Treatment Protocols

Disease Category:

Adjuvant Breast, Breast

Status:

Open

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

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

Status:

Open

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

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

Status:

New, Open

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

SWOG S1703

Primary Category:

Cancer Control and Prevention Protocols

Disease Category:

Breast, Breast Metastatic

Status:

Open

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

Eligible for screening study DCP 001

SWOG S1706

Primary Category:

Radiation Oncology, Treatment Protocols

Disease Category:

Adjuvant Breast, Breast

Status:

New, Open

A Phase II Randomized Trial of Olaparib (NSC-747856) Administered Concurrently with Radiotherapy Versus Radiotherapy Alone for Inflammatory Breast Cancer

NCT#03598257

Cancer Care Delivery

ALLIANCE A231701CD

Primary Category:

Cancer Care Delivery, Surgical Protocols

Disease Category:

Breast, Cancer Care Delivery

Status:

New, Open

Increasing Socioeconomically Disadvantaged Patients’ Engagement in Breast Cancer Surgery Decision Making Through a Shared Decision Making Intervention

NCT#03766009

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

Status:

Open

Longitudinal Assessment of Financial Burden in Patients with Colon or Rectal Cancer Treated with Curative Intent

NCT#03516942

Eligible for screening study DCP 001

Accrual to the “Colon Cancer, Receiving Chemotherapy” (or Colon/Chemo) cohort will be closed to accrual and the “Rectal Cancer, Receiving Chemotherapy” (or Rectal/Chemo) cohort will be suspended to accrual on May 2, 2019, as they are nearing their study-specified accrual thresholds.

ECOG-ACRIN EAQ171CD

Primary Category:

Cancer Care Delivery

Disease Category:

Cancer Care Delivery

Status:

New, Open

Implementing a Virtual Tobacco Treatment in Community Oncology Practices: “Smoke Free Support Study 2.0”

NCT#03808818

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

Status:

Open

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

NCT#02728596

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

Status:

Closed

Implementation of a Prospective Financial Impact Assessment Tool in Patients with Metastatic Colorectal Cancer

 

NCT#02728804

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

Status:

New, Open

Supportive Care Service Availability for Cancer Caregivers in Community Oncology Practices

NCT#03746314

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

Status:

Open

Direct Oral Anticoagulants (DOACs) versus LMWH +/- Warfarin for VTE in Cancer: A Randomized Effectiveness Trial (CANVAS Trial)

NCT#02744092

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

Status:

Open

Electronic patient reporting of symptoms during outpatient cancer treatment: A U.S. national randomized controlled trial (the “PRO-TECT” trial)

NCT#03249090

Limited institution study – Only open to:  Billings Clinic & Bozeman Health

ALLIANCE A021502

Primary Category:

Treatment Protocols

Disease Category:

Colon, Gastrointestinal

Status:

Open

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

Site Delegation of Tasks Log required prior to registration of any patients.

ALLIANCE A021602

Primary Category:

Treatment Protocols

Disease Category:

Carcinoid, Neuroendocrine, Pancreatic

Status:

Open

Randomized, Double-Blinded Phase III Study of CABozantinib Versus Placebo IN Patients with Advanced NEuroendocrine Tumors After Progression on Everolimus (CABINET)

NCT#03375320

Eligible for screening study DCP 001

ALLIANCE A221701

Primary Category:

Cancer Control and Prevention Protocols

Disease Category:

Breast, Gastrointestinal, Genitourinary, Neuroendocrine, Pancreatic, Renal

Status:

New, Open

Phase III Placebo-Controlled Trial to Evaluate Dexamethasone Use for Everolimus-Induced Oral Stomatitis: Prevention versus Early Treatment Approaches

NCT#03839940

Eligible for screening study DCP 001

ALLIANCE C80702

Primary Category:

Treatment Protocols

Disease Category:

Colon, Gastrointestinal

Status:

Closed

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

ALLIANCE C80803

Primary Category:

Radiation Oncology, Treatment Protocols

Disease Category:

Esophageal, Gastrointestinal

Status:

Closed

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

ALLIANCE N1048

Primary Category:

Radiation Oncology, Treatment Protocols

Disease Category:

Gastrointestinal, Rectal

Status:

Closed

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

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

Status:

Open

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

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

ECOG-ACRIN EA2165

Primary Category:

Radiation Oncology, Treatment Protocols

Disease Category:

Anal, Gastrointestinal

Status:

Open

A Randomized Phase II Study of Nivolumab After Combined Modality Therapy (CMT) in High Risk Anal Cancer

NCT#03233711

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

Status:

Closed

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

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

Status:

Open

Longitudinal Assessment of Financial Burden in Patients with Colon or Rectal Cancer Treated with Curative Intent

NCT#03516942

Eligible for screening study DCP 001

Accrual to the “Colon Cancer, Receiving Chemotherapy” (or Colon/Chemo) cohort will be closed to accrual and the “Rectal Cancer, Receiving Chemotherapy” (or Rectal/Chemo) cohort will be suspended to accrual on May 2, 2019, as they are nearing their study-specified accrual thresholds.

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

Status:

Open

Molecular Analysis for Therapy Choice (MATCH)

Eligible for screening study DCP 001

NCT#02465060

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

(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

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 has met its accrual goal and is temporarily suspended.

NRG GI004

Primary Category:

Treatment Protocols

Disease Category:

Colon, Colon Metastatic, Gastrointestinal, Rectal, Rectal Metastatic

Status:

Open

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

Site Delegation of Tasks Log required prior to registration of any patients.

NRG R0848

Primary Category:

Radiation Oncology, Treatment Protocols

Disease Category:

Gastrointestinal, Pancreatic

Status:

Closed

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

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

Status:

Closed

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

NRG R1201

Primary Category:

Radiation Oncology, Treatment Protocols

Disease Category:

Gastrointestinal, Pancreatic

Status:

Closed

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

SWOG S1417CD

Primary Category:

Cancer Care Delivery, Cancer Control and Prevention Protocols

Disease Category:

Cancer Care Delivery, Colon, Colon Metastatic, Gastrointestinal, Rectal, Rectal Metastatic

Status:

Closed

Implementation of a Prospective Financial Impact Assessment Tool in Patients with Metastatic Colorectal Cancer

 

NCT#02728804

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

Status:

Closed

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

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

Status:

Temporarily Closed

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

Effective immediately, May 17th, 2019, S1613 Step 1, is temporarily closed to accrual of new patients to accommodate the relocation of the screening laboratory. Patients may continue to be registered to Step 2.

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

Status:

New, Open

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

SWOG S1815

Primary Category:

Treatment Protocols

Disease Category:

Cholangiocarcinoma, Gallbladder, Gastrointestinal

Status:

New, Open

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

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

Status:

Open

Direct Oral Anticoagulants (DOACs) versus LMWH +/- Warfarin for VTE in Cancer: A Randomized Effectiveness Trial (CANVAS Trial)

NCT#02744092

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

Status:

Open

Electronic patient reporting of symptoms during outpatient cancer treatment: A U.S. national randomized controlled trial (the “PRO-TECT” trial)

NCT#03249090

Limited institution study – Only open to:  Billings Clinic & Bozeman Health

ALLIANCE A031102

Primary Category:

Treatment Protocols

Disease Category:

Genitourinary

Status:

Open

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

ALLIANCE A031201

Primary Category:

Treatment Protocols

Disease Category:

Genitourinary, Prostate, Prostate Metastatic

Status:

Closed

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

ALLIANCE A031203

Primary Category:

Treatment Protocols

Disease Category:

Genitourinary, Renal, Renal Metastatic

Status:

Closed

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

ALLIANCE A031501

Primary Category:

Treatment Protocols

Disease Category:

Bladder, Genitourinary

Status:

New, Open

Phase III Randomized Adjuvant study of MK-3475 (Pembrolizumab) in muScle invaSive and locAlly aDvanced urOthelial caRcinoma (AMBASSADOR) Versus Observation

NCT#03244384

Eligible for screening study DCP 001

ALLIANCE A031701

Primary Category:

Treatment Protocols

Disease Category:

Bladder, Genitourinary

Status:

Open

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

ALLIANCE A031702

Primary Category:

Treatment Protocols

Disease Category:

Bladder, Genitourinary, Prostate, Renal

Status:

New, Open

Phase II Study of Cabozantinib in Combination with Nivolumab and Ipilimumab in Rare Genitourinary Tumors

NCT#03866382

 

ALLIANCE A031704

Primary Category:

Treatment Protocols

Disease Category:

Genitourinary, Renal, Renal Metastatic

Status:

New, Open

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]

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

Status:

New, Open

Phase III Placebo-Controlled Trial to Evaluate Dexamethasone Use for Everolimus-Induced Oral Stomatitis: Prevention versus Early Treatment Approaches

NCT#03839940

Eligible for screening study DCP 001

ALLIANCE C70807

Primary Category:

Cancer Control and Prevention Protocols

Disease Category:

Genitourinary, Prostate

Status:

Closed

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

ALLIANCE C90203

Primary Category:

Treatment Protocols

Disease Category:

Genitourinary, Prostate

Status:

Closed

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

ECOG-ACRIN EA8143

Primary Category:

Treatment Protocols

Disease Category:

Genitourinary, Renal

Status:

Open

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

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

Status:

Open

Cabazitaxel with Abiraterone Versus Abiraterone Alone Randomized Trial for Extensive Disease Following Docetaxel: The CHAARTED2 Trial

NCT#03419234

ECOG-ACRIN EA8171

Primary Category:

Treatment Protocols

Disease Category:

Genitourinary, Prostate

Status:

Open

Multiparametric MRI (mpMRI) for Preoperative Staging and Treatment Planning for Newly-Diagnosed Prostate Cancer

NCT#03697148

EA8171 will reactivate on 10/15/18 with the implementation of Addendum 1.

EA8171 is temporarily suspended, effective immediately, 07/13/18.  It will reopen to accrual once administrative updates are processed.

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

Status:

Closed

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

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

Status:

Open

Molecular Analysis for Therapy Choice (MATCH)

Eligible for screening study DCP 001

NCT#02465060

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

(http://ecog-acrin.org/nci-match-eay131-designated-labs)

NRG GU002

Primary Category:

Radiation Oncology, Treatment Protocols

Disease Category:

Genitourinary, Prostate

Status:

Open

Phase II-III Trial of Adjuvant Radiotherapy and Androgen Deprivation Following Radical Prostatectomy With or Without Adjuvant Docetaxel

 

NCT#03070886

NRG GU003

Primary Category:

Radiation Oncology, Treatment Protocols

Disease Category:

Genitourinary, Prostate

Status:

Closed

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

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

Status:

Open

Phase III IGRT and SBRT Vs IGRT and Hypofractionated IMRT for Localized Intermediate Risk Prostate Cancer

Eligible for screening study DCP 001

NCT#03367702

*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

Status:

Open

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

NRG R0521

Primary Category:

Radiation Oncology, Treatment Protocols

Disease Category:

Genitourinary, Prostate

Status:

Closed

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

NRG R0534

Primary Category:

Radiation Oncology, Treatment Protocols

Disease Category:

Genitourinary, Prostate, Prostate Recurrent

Status:

Closed

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

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

Status:

Closed

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

NRG R0924

Primary Category:

Radiation Oncology, Treatment Protocols

Disease Category:

Genitourinary, Prostate

Status:

Closed

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

SWOG S0931

Primary Category:

Treatment Protocols

Disease Category:

Genitourinary, Renal

Status:

Closed

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

SWOG S1216

Primary Category:

Treatment Protocols

Disease Category:

Genitourinary, Prostate, Prostate Metastatic

Status:

Closed

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

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

Status:

Closed

A Randomized Phase II Study of CO-eXpression ExtrapolatioN (COXEN) with Neoadjuvant Chemotherapy for Localized, Muscle-Invasive Bladder Cancer

NCT#02177695

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

Status:

Open

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

Partial permanent closure for Arm 3 and Arm 4 effective 12/05/18.

SWOG S1602

Primary Category:

Treatment Protocols

Disease Category:

Bladder, Genitourinary

Status:

Open

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

Eligible for screening study DCP 001

SWOG S1605

Primary Category:

Treatment Protocols

Disease Category:

Bladder, Genitourinary

Status:

Closed

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

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

Status:

New, Open

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

SWOG S1802

Primary Category:

Radiation Oncology, Surgical Protocols, Treatment Protocols

Disease Category:

Genitourinary, Prostate, Prostate Metastatic

Status:

New, Open

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

Eligible for screening study DCP 001

SWOG S1806

Primary Category:

Radiation Oncology, Treatment Protocols

Disease Category:

Bladder, Genitourinary

Status:

New, Open

Phase III Randomized Trial of Concurrent Chemoradiotherapy with or Without Atezolizumab in Localized Muscle Invasive Bladder Cancer

NCT#03775265

 

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

Status:

Open

Direct Oral Anticoagulants (DOACs) versus LMWH +/- Warfarin for VTE in Cancer: A Randomized Effectiveness Trial (CANVAS Trial)

NCT#02744092

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

Status:

Open

Electronic patient reporting of symptoms during outpatient cancer treatment: A U.S. national randomized controlled trial (the “PRO-TECT” trial)

NCT#03249090

Limited institution study – Only open to:  Billings Clinic & Bozeman Health

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

Status:

Closed

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

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

Status:

Open

Molecular Analysis for Therapy Choice (MATCH)

Eligible for screening study DCP 001

NCT#02465060

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

(http://ecog-acrin.org/nci-match-eay131-designated-labs)

GOG Foundation GOG 3018/VB-111-701

Primary Category:

Treatment Protocols

Disease Category:

Gynecologic, Ovarian

Status:

New, Open

The OVAL Study: A Randomized, Controlled, Double-Arm, Double-Blind, Multi-Center Study of Ofranergene Obadenovec (VB-111) Combined with Paclitaxel vs. Paclitaxel Combined with Placebo for the Treatment of Recurrent Platinum-Resistant Ovarian Cancer

NCT#03398655

GOG Foundation GOG-3015 / Y039523

Primary Category:

Treatment Protocols

Disease Category:

Gynecologic, Ovarian, Ovarian Metastatic

Status:

Closed

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

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

Status:

New, Open

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

NRG CC004

Primary Category:

Cancer Control and Prevention Protocols

Disease Category:

Breast, Gynecologic

Status:

Open

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

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

Status:

Closed

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

NRG G0225

Primary Category:

Cancer Control and Prevention Protocols

Disease Category:

Gynecologic

Status:

Closed

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

Eligible for screening study DCP 001

NRG G0237

Primary Category:

Cancer Control and Prevention Protocols

Disease Category:

GYN Other

Status:

Open

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

Eligible for screening study DCP 001

Effective August 1st, 2019, at 3 P.M. MST, study G0237 will close to accrual.

 

NRG G0263

Primary Category:

Radiation Oncology, Treatment Protocols

Disease Category:

Cervical, Gynecologic

Status:

Open

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

NRG G0270

Primary Category:

Radiation Oncology, Surgical Protocols, Treatment Protocols

Disease Category:

Gynecologic

Status:

Closed

GROningen INternational Study on Sentinel nodes in Vulvar cancer (GROINSS-V) II

NCT#01500512

NRG G0274

Primary Category:

Radiation Oncology, Treatment Protocols

Disease Category:

Cervical, Gynecologic

Status:

Closed

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

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

Status:

Closed

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

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

Status:

Closed

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

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

Status:

Closed

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

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

Status:

Open

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

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

Status:

Open

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

NRG GY007

Primary Category:

Surgical Protocols, Treatment Protocols

Disease Category:

Gynecologic, Ovarian, Ovarian Metastatic

Status:

New, Open

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

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

Status:

Closed

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

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

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

Status:

Closed

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

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

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

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

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

Status:

Upcoming - Pending IRB Review

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

NCT#03914612

NRG R0724

Primary Category:

Radiation Oncology, Treatment Protocols

Disease Category:

Cervical, Gynecologic

Status:

Open

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

NRG R1203

Primary Category:

Radiation Oncology, Treatment Protocols

Disease Category:

Cervical, Endometrial, Gynecologic

Status:

Closed

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

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

Status:

New, Open

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

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

Status:

Open

Direct Oral Anticoagulants (DOACs) versus LMWH +/- Warfarin for VTE in Cancer: A Randomized Effectiveness Trial (CANVAS Trial)

NCT#02744092

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

Status:

Open

Electronic patient reporting of symptoms during outpatient cancer treatment: A U.S. national randomized controlled trial (the “PRO-TECT” trial)

NCT#03249090

Limited institution study – Only open to:  Billings Clinic & Bozeman Health

ALLIANCE A091404

Primary Category:

Treatment Protocols

Disease Category:

Head and Neck

Status:

Closed

A Phase II Study of Enzalutamide (NSC# 766085) for Patients with Androgen Receptor Positive Salivary Cancers

NCT#02749903

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

Status:

Closed

A Phase III Randomized Trial of Chemotherapy with or Without Bevacizumab in Patients with Recurrent or Metastatic Head and Neck Cancer

NCT#00588770

ECOG-ACRIN EA3132

Primary Category:

Radiation Oncology, Treatment Protocols

Disease Category:

Head and Neck

Status:

Open

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

ECOG-ACRIN EA3161

Primary Category:

Treatment Protocols

Disease Category:

Head and Neck

Status:

Open

Nivolumab Versus Observation in Treating Patients With Locally Advanced, Intermediate Risk HPV-Positive Oropharyngeal Cancer

NCT#03811015

ECOG-ACRIN EA3163

Primary Category:

Radiation Oncology, Surgical Protocols, Treatment Protocols

Disease Category:

Head and Neck

Status:

Open

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

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

Status:

Closed

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

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

Status:

Open

Molecular Analysis for Therapy Choice (MATCH)

Eligible for screening study DCP 001

NCT#02465060

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

(http://ecog-acrin.org/nci-match-eay131-designated-labs)

NRG HN002

Primary Category:

Radiation Oncology, Treatment Protocols

Disease Category:

Head and Neck

Status:

Closed

A Randomized Phase II Trial for Patients with p16 Positive, Non-Smoking Associated, Locoregionally Advanced Oropharyngeal Cancer

NCT#02254278

Closed effective 02/07/17.  Accrual goal met.

NRG HN004

Primary Category:

Radiation Oncology, Treatment Protocols

Disease Category:

Head and Neck

Status:

Open

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

HN004 is temporarily closed to accrual effective immediately, 06/13/18, because the first dose level of the lead-in cohort has enrolled 10 patients. The trial will be closed for approximately 3 months for toxicity assessment.

Site Delegation of Tasks Log required prior to registration of any patients.

NRG R0920

Primary Category:

Radiation Oncology, Treatment Protocols

Disease Category:

Head and Neck

Status:

Closed

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

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

Status:

Closed

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

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

Status:

New, Open

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

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

Status:

Open

Direct Oral Anticoagulants (DOACs) versus LMWH +/- Warfarin for VTE in Cancer: A Randomized Effectiveness Trial (CANVAS Trial)

NCT#02744092

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

Status:

Closed

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

ALLIANCE A041501

Primary Category:

Treatment Protocols

Disease Category:

Acute Lymphocytic Leukemia, Leukemia

Status:

Open

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

Eligible for screening study DCP 001

ALLIANCE A041701

Primary Category:

Treatment Protocols

Disease Category:

Acute Myeloid Leukemia, Leukemia

Status:

New, Open

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

ALLIANCE A041702

Primary Category:

Treatment Protocols

Disease Category:

Chronic Lymphocytic Leukemia, Leukemia

Status:

New, Open

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

Eligible for screening study DCP 001

ECOG-ACRIN E1910

Primary Category:

Treatment Protocols

Disease Category:

Acute Lymphocytic Leukemia, Leukemia

Status:

Open

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

ECOG-ACRIN E1912

Primary Category:

Treatment Protocols

Disease Category:

Chronic Lymphocytic Leukemia, Leukemia

Status:

Closed

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

ECOG-ACRIN EA9161

Primary Category:

Treatment Protocols

Disease Category:

Chronic Lymphocytic Leukemia, Leukemia

Status:

New, Open

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

Eligible for screening study DCP 001

ECOG-ACRIN EA9171

Primary Category:

Treatment Protocols

Disease Category:

Chronic Myeloid Leukemia, Leukemia

Status:

New, Open

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

ECOG-ACRIN NHLBI-MDS

Primary Category:

Cancer Control and Prevention Protocols

Disease Category:

Leukemia, Myelodysplastic Syndrome

Status:

Open

The National Myelodysplastic Syndromes (MDS) Study

 

NCT#02775383

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

Status:

Closed

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

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

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

Status:

New, Open

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

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

Status:

Open

Direct Oral Anticoagulants (DOACs) versus LMWH +/- Warfarin for VTE in Cancer: A Randomized Effectiveness Trial (CANVAS Trial)

NCT#02744092

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

Status:

Open

Electronic patient reporting of symptoms during outpatient cancer treatment: A U.S. national randomized controlled trial (the “PRO-TECT” trial)

NCT#03249090

Limited institution study – Only open to:  Billings Clinic & Bozeman Health

ALLIANCE A081105

Primary Category:

Treatment Protocols

Disease Category:

Lung, Lung - Non-Small Cell, Molecular Profiling

Status:

Open

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

ALLIANCE A151216

Primary Category:

Treatment Protocols

Disease Category:

Lung, Lung - Non-Small Cell, Molecular Profiling

Status:

Open

Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial (ALCHEMIST)
A screening trial for A081105E4512, and EA5142.

Eligible for screening study DCP 001

NCT#02194738

ALLIANCE A211401

Primary Category:

Cancer Control and Prevention Protocols, Surgical Protocols

Disease Category:

Lung, Lung - Non-Small Cell, Lung - Small Cell

Status:

Open

Reducing Surgical Complications in Newly Diagnosed Lung Cancer Patients Who Smoke Cigarettes

 

NCT#02856581

ALLIANCE A221504

Primary Category:

Cancer Control and Prevention Protocols

Disease Category:

Lung, Lung - Non-Small Cell, Lung - Non-Small Cell Metastatic

Status:

Open

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

Eligible for screening study DCP 001

ALLIANCE C140503

Primary Category:

Surgical Protocols

Disease Category:

Lung, Lung - Non-Small Cell

Status:

Closed

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

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

Status:

Open

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

The QOL Substudy C70702 (embedded in C30610) will soon meet its study accrual goal. Therefore,  EFFECTIVE August 30, 2017 at 4:30 pm ET, C70702 will permanently close to new patient accrual.

ECOG-ACRIN E4512

Primary Category:

Treatment Protocols

Disease Category:

Lung, Lung - Non-Small Cell, Molecular Profiling

Status:

Open

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

ECOG-ACRIN E5508

Primary Category:

Treatment Protocols

Disease Category:

Lung, Lung - Non-Small Cell, Lung - Non-Small Cell Metastatic

Status:

Closed

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

ECOG-ACRIN EA5142

Primary Category:

Treatment Protocols

Disease Category:

Lung, Lung - Non-Small Cell, Molecular Profiling

Status:

Open

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

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

Status:

Closed

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

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

Status:

Closed

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

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

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

Status:

New, Open

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

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

Status:

Closed

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

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

Status:

Open

Molecular Analysis for Therapy Choice (MATCH)

Eligible for screening study DCP 001

NCT#02465060

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

(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

Status:

Open

Randomized Phase II/III Trial of Prophylatic Cranial Irradiation With or Without Hippocampal Avoidance for Small Cell Lung Cancer

NCT#02635009

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

Status:

Closed

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

NRG LU002

Primary Category:

Radiation Oncology, Treatment Protocols

Disease Category:

Lung, Lung - Non-Small Cell, Lung - Non-Small Cell Metastatic

Status:

Open

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

NRG LU003

Primary Category:

Treatment Protocols

Disease Category:

Lung, Lung - Non-Small Cell, Lung - Non-Small Cell Metastatic

Status:

Open

A Biomarker-Driven Protocol for Previously Treated ALK-Positive Non-Squamous NSCLC Patients: The NCI-NRG ALK Master Protocol

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

Status:

New, Open

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

NRG LU005

Primary Category:

Radiation Oncology, Treatment Protocols

Disease Category:

Lung, Lung - Small Cell, Lung - Small Cell Limited Stage

Status:

New, Open

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

NRG R1306

Primary Category:

Radiation Oncology, Treatment Protocols

Disease Category:

Lung, Lung - Non-Small Cell

Status:

Closed

A Randomized Phase II Study of Individualized Combined Modality Therapy for Stage III Non-Small Cell Lung Cancer (NSCLC)

NCT#01822496

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

Status:

Open

A Master Protocol to Evaluate Biomarker-Driven Therapies and Immunotherapies in Previously-Treated Non-Small Cell Lung Cancer (Lung-MAP Screening Study)

NCT#03851445

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

Status:

Closed

A Biomarker-Driven Master Protocol for Previously Treated Squamous Cell Lung Cancer

 

Eligible for screening study DCP 001

NCT#02154490

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

Status:

Closed

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

SWOG S1400B

Primary Category:

Treatment Protocols

Disease Category:

Lung, Lung - Non-Small Cell, Lung - Non-Small Cell Metastatic, Molecular Profiling

Status:

Closed

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

SWOG S1400C

Primary Category:

Treatment Protocols

Disease Category:

Lung, Lung - Non-Small Cell, Lung - Non-Small Cell Metastatic, Molecular Profiling

Status:

Closed

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

SWOG S1400D

Primary Category:

Treatment Protocols

Disease Category:

Lung, Lung - Non-Small Cell, Lung - Non-Small Cell Metastatic, Molecular Profiling

Status:

Closed

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

SWOG S1400E

Primary Category:

Treatment Protocols

Disease Category:

Lung, Lung - Non-Small Cell, Lung - Non-Small Cell Metastatic, Molecular Profiling

Status:

Closed

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

SWOG S1400F

Primary Category:

Treatment Protocols

Disease Category:

Lung, Lung - Non-Small Cell, Lung - Non-Small Cell Metastatic, Molecular Profiling

Status:

Temporarily Closed

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

Effective February 22, 2019 at 2:00 pm Pacific Time, Cohort 1, the acquired resistance cohort of substudy S1400F will be temporarily closed to accrual in order to allow data to mature to conduct the planned interim analysis.  Please note that Cohort 2, the primary resistance cohort, remains open to accrual.

Effective May 15, 2019 at 2:00 pm Pacific Time, Cohort 2, the primary resistance of cohort of substudy S1400F will be temporarily closed to accrual in order to allow data to mature to conduct the planned interim analysis.

SWOG S1400G

Primary Category:

Treatment Protocols

Disease Category:

Lung, Lung - Non-Small Cell, Lung - Non-Small Cell Metastatic, Molecular Profiling

Status:

Closed

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

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

Status:

Closed

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

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

Status:

Closed

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

 

SWOG S1403

Primary Category:

Treatment Protocols

Disease Category:

Lung, Lung - Non-Small Cell, Lung - Non-Small Cell Metastatic

Status:

Closed

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

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

Status:

Closed

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

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

Status:

New, Open

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

SWOG S1619

Primary Category:

Radiation Oncology, Surgical Protocols, Treatment Protocols

Disease Category:

Lung, Mesothelioma

Status:

Open

A Feasibility Trial of Neoadjuvant Cisplatin-Pemetrexed with Atezolizumab in Combination and in Maintenance for Resectable Malignant Pleural Mesothelioma

 

NCT#03228537

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

Status:

New, Open

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

Status:

New, Open

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

See Screening Protocol LUNGMAP

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

Status:

Open

Direct Oral Anticoagulants (DOACs) versus LMWH +/- Warfarin for VTE in Cancer: A Randomized Effectiveness Trial (CANVAS Trial)

NCT#02744092

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

Status:

Open

Electronic patient reporting of symptoms during outpatient cancer treatment: A U.S. national randomized controlled trial (the “PRO-TECT” trial)

NCT#03249090

Limited institution study – Only open to:  Billings Clinic & Bozeman Health

ALLIANCE A021602

Primary Category:

Treatment Protocols

Disease Category:

Carcinoid, Neuroendocrine, Pancreatic

Status:

Open

Randomized, Double-Blinded Phase III Study of CABozantinib Versus Placebo IN Patients with Advanced NEuroendocrine Tumors After Progression on Everolimus (CABINET)

NCT#03375320

Eligible for screening study DCP 001

ALLIANCE A051301

Primary Category:

Treatment Protocols

Disease Category:

Diffuse Large B-cell Lymphoma, Lymphoma, Non-Hodgkin Lymphoma

Status:

Open

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

Site Delegation of Tasks Log required prior to registration of any patients.

ALLIANCE C50904

Primary Category:

Treatment Protocols

Disease Category:

Follicular Lymphoma, Lymphoma, Non-Hodgkin Lymphoma

Status:

Closed

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

ECOG-ACRIN E1411

Primary Category:

Treatment Protocols

Disease Category:

Lymphoma, Mantle Cell Lymphoma, Non-Hodgkin Lymphoma

Status:

Closed

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

ECOG-ACRIN E1412

Primary Category:

Treatment Protocols

Disease Category:

Diffuse Large B-cell Lymphoma, Lymphoma, Non-Hodgkin Lymphoma

Status:

Closed

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

ECOG-ACRIN E2408

Primary Category:

Treatment Protocols

Disease Category:

Follicular Lymphoma, Lymphoma

Status:

Closed

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

ECOG-ACRIN E4412

Primary Category:

Treatment Protocols

Disease Category:

Hodgkin Lymphoma, Lymphoma

Status:

New, Open

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

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

ECOG-ACRIN EA4151

Primary Category:

Treatment Protocols

Disease Category:

Lymphoma, Mantle Cell Lymphoma, Non-Hodgkin Lymphoma

Status:

Open

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

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

Status:

Closed

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

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

Status:

Open

Molecular Analysis for Therapy Choice (MATCH)

Eligible for screening study DCP 001

NCT#02465060

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

(http://ecog-acrin.org/nci-match-eay131-designated-labs)

SWOG S1608

Primary Category:

Treatment Protocols

Disease Category:

Follicular Lymphoma, Lymphoma, Non-Hodgkin Lymphoma

Status:

Open

Randomized Phase II Trial in Early Relapsing or Refractory Follicular Lymphoma

 

NCT#03269669

Molecular Profiling

ALLIANCE A081105

Primary Category:

Treatment Protocols

Disease Category:

Lung, Lung - Non-Small Cell, Molecular Profiling

Status:

Open

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

ALLIANCE A151216

Primary Category:

Treatment Protocols

Disease Category:

Lung, Lung - Non-Small Cell, Molecular Profiling

Status:

Open

Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial (ALCHEMIST)
A screening trial for A081105E4512, and EA5142.

Eligible for screening study DCP 001

NCT#02194738

ECOG-ACRIN E4512

Primary Category:

Treatment Protocols

Disease Category:

Lung, Lung - Non-Small Cell, Molecular Profiling

Status:

Open

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

ECOG-ACRIN EA5142

Primary Category:

Treatment Protocols

Disease Category:

Lung, Lung - Non-Small Cell, Molecular Profiling

Status:

Open

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

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

Status:

Closed

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

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

Status:

Open

Molecular Analysis for Therapy Choice (MATCH)

Eligible for screening study DCP 001

NCT#02465060

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

(http://ecog-acrin.org/nci-match-eay131-designated-labs)

ECOG-ACRIN EAY131-A

Primary Category:

Treatment Protocols

Disease Category:

Molecular Profiling

Status:

Open

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

Protocol     Eligibility & Calendar

ECOG-ACRIN EAY131-B

Primary Category:

Treatment Protocols

Disease Category:

Molecular Profiling

Status:

Closed

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

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

ECOG-ACRIN EAY131-C2

Primary Category:

Treatment Protocols

Disease Category:

Molecular Profiling

Status:

Open

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

ECOG-ACRIN EAY131-E

Primary Category:

Treatment Protocols

Disease Category:

Molecular Profiling

Status:

Open

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

ECOG-ACRIN EAY131-F

Primary Category:

Treatment Protocols

Disease Category:

Molecular Profiling

Status:

Closed

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

ECOG-ACRIN EAY131-G

Primary Category:

Treatment Protocols

Disease Category:

Molecular Profiling

Status:

Closed

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

ECOG-ACRIN EAY131-H

Primary Category:

Treatment Protocols

Disease Category:

Molecular Profiling

Status:

Closed

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

ECOG-ACRIN EAY131-I

Primary Category:

Treatment Protocols

Disease Category:

Molecular Profiling

Status:

Closed

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

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

ECOG-ACRIN EAY131-K1

Primary Category:

Treatment Protocols

Disease Category:

Molecular Profiling

Status:

Closed

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

 

 

ECOG-ACRIN EAY131-K2

Primary Category:

Treatment Protocols

Disease Category:

Molecular Profiling

Status:

Closed

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

ECOG-ACRIN EAY131-L

Primary Category:

Treatment Protocols

Disease Category:

Molecular Profiling

Status:

Open

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

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

ECOG-ACRIN EAY131-N

Primary Category:

Treatment Protocols

Disease Category:

Molecular Profiling

Status:

Closed

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

ECOG-ACRIN EAY131-P

Primary Category:

Treatment Protocols

Disease Category:

Molecular Profiling

Status:

Closed

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

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

Status:

Closed

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

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

Status:

Closed

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

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

Status:

Closed

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

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

Status:

Closed

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

ECOG-ACRIN EAY131-T

Primary Category:

Treatment Protocols

Disease Category:

Molecular Profiling

Status:

Open

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

ECOG-ACRIN EAY131-U

Primary Category:

Treatment Protocols

Disease Category:

Molecular Profiling

Status:

Closed

MATCH Treatment Subprotocol U: VS-6063 (defactinib) in Patients with Tumors with NF2 Loss

 

(See required screening study ECOG-ACRIN EAY131)

NCT#02465060

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

Status:

Open

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

ECOG-ACRIN EAY131-W

Primary Category:

Treatment Protocols

Disease Category:

Molecular Profiling

Status:

Closed

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

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

Status:

Closed

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

ECOG-ACRIN EAY131-Y

Primary Category:

Treatment Protocols

Disease Category:

Molecular Profiling

Status:

Closed

MATCH Treatment Subprotocol Y: AZD5363 in Patients with Tumors with AKT Mutations

(See required screening study ECOG-ACRIN EAY131)

NCT#02465060

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

Status:

Closed

MATCH Treatment Subprotocol Z1A: Binimetinib in Patients with Tumors (Other Than Melanoma) with NRAS Mutations

(See required screening study ECOG-ACRIN EAY131)

NCT#02465060

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

Status:

Closed

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

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

ECOG-ACRIN EAY131-Z1D

Primary Category:

Treatment Protocols

Disease Category:

Molecular Profiling

Status:

Closed

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

ECOG-ACRIN EAY131-Z1E

Primary Category:

Treatment Protocols

Disease Category:

Molecular Profiling

Status:

Open

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

ECOG-ACRIN EAY131-Z1F

Primary Category:

Treatment Protocols

Disease Category:

Molecular Profiling

Status:

Closed

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

ECOG-ACRIN EAY131-Z1G

Primary Category:

Treatment Protocols

Disease Category:

Molecular Profiling

Status:

Open

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

ECOG-ACRIN EAY131-Z1H

Primary Category:

Treatment Protocols

Disease Category:

Molecular Profiling

Status:

Open

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

ECOG-ACRIN EAY131-Z1I

Primary Category:

Treatment Protocols

Disease Category:

Molecular Profiling

Status:

Closed

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

ECOG-ACRIN EAY131-Z1K

Primary Category:

Treatment Protocols

Disease Category:

Molecular Profiling, Other

Status:

New, Open

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

ECOG-ACRIN EAY131-Z1L

Primary Category:

Treatment Protocols

Disease Category:

Molecular Profiling, Other

Status:

New, Open

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

NCI 9671

Primary Category:

Cancer Control and Prevention Protocols

Disease Category:

Molecular Profiling, Other

Status:

Closed

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

SWOG S1400

Primary Category:

Treatment Protocols

Disease Category:

Lung, Lung - Non-Small Cell, Lung - Non-Small Cell Metastatic, Molecular Profiling

Status:

Closed

A Biomarker-Driven Master Protocol for Previously Treated Squamous Cell Lung Cancer

 

Eligible for screening study DCP 001

NCT#02154490

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

Status:

Closed

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

SWOG S1400B

Primary Category:

Treatment Protocols

Disease Category:

Lung, Lung - Non-Small Cell, Lung - Non-Small Cell Metastatic, Molecular Profiling

Status:

Closed

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

SWOG S1400C

Primary Category:

Treatment Protocols

Disease Category:

Lung, Lung - Non-Small Cell, Lung - Non-Small Cell Metastatic, Molecular Profiling

Status:

Closed

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

SWOG S1400D

Primary Category:

Treatment Protocols

Disease Category:

Lung, Lung - Non-Small Cell, Lung - Non-Small Cell Metastatic, Molecular Profiling

Status:

Closed

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

SWOG S1400E

Primary Category:

Treatment Protocols

Disease Category:

Lung, Lung - Non-Small Cell, Lung - Non-Small Cell Metastatic, Molecular Profiling

Status:

Closed

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

SWOG S1400F

Primary Category:

Treatment Protocols

Disease Category:

Lung, Lung - Non-Small Cell, Lung - Non-Small Cell Metastatic, Molecular Profiling

Status:

Temporarily Closed

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

Effective February 22, 2019 at 2:00 pm Pacific Time, Cohort 1, the acquired resistance cohort of substudy S1400F will be temporarily closed to accrual in order to allow data to mature to conduct the planned interim analysis.  Please note that Cohort 2, the primary resistance cohort, remains open to accrual.

Effective May 15, 2019 at 2:00 pm Pacific Time, Cohort 2, the primary resistance of cohort of substudy S1400F will be temporarily closed to accrual in order to allow data to mature to conduct the planned interim analysis.

SWOG S1400G

Primary Category:

Treatment Protocols

Disease Category:

Lung, Lung - Non-Small Cell, Lung - Non-Small Cell Metastatic, Molecular Profiling

Status:

Closed

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

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

Status:

Closed

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

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

Status:

Closed

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

 

SWOG S1609

Primary Category:

Treatment Protocols

Disease Category:

Molecular Profiling

Status:

Open

DART: Dual Anti-CTLA-4 and Anti-PD-1 Blockade in Rare Tumors

NCT#02834013

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.

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

Status:

Open

Direct Oral Anticoagulants (DOACs) versus LMWH +/- Warfarin for VTE in Cancer: A Randomized Effectiveness Trial (CANVAS Trial)

NCT#02744092

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

Status:

Open

Electronic patient reporting of symptoms during outpatient cancer treatment: A U.S. national randomized controlled trial (the “PRO-TECT” trial)

NCT#03249090

Limited institution study – Only open to:  Billings Clinic & Bozeman Health

ALLIANCE A011203

Primary Category:

Treatment Protocols

Disease Category:

Breast, Breast Metastatic

Status:

Closed

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

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

Status:

Closed

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

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

Status:

New, Open

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

Eligible for screening study DCP 001

ECOG-ACRIN E1A11

Primary Category:

Treatment Protocols

Disease Category:

Multiple Myeloma

Status:

Closed

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

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

Status:

Closed

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

ECOG-ACRIN E3A06

Primary Category:

Treatment Protocols

Disease Category:

Multiple Myeloma

Status:

Closed

Randomized Phase III Trial of Lenalidomide Versus Observation Alone in Patients with Asymptomatic High-Risk Smoldering Multiple Myeloma

 

NCT#01169337

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.

NRG BR002

Primary Category:

Radiation Oncology, Treatment Protocols

Disease Category:

Breast, Breast Metastatic

Status:

Open

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

NCT#02364557

NRG BR004

Primary Category:

Treatment Protocols

Disease Category:

Breast, Breast Metastatic

Status:

New, Open

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

SWOG S1304

Primary Category:

Treatment Protocols

Disease Category:

Multiple Myeloma

Status:

Closed

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

SWOG S1416

Primary Category:

Treatment Protocols

Disease Category:

Breast, Breast Metastatic

Status:

Closed

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

S1416 has an accrual goal of 235 in the main cohort and 98 in the brain metastases cohort for a total of 333 patients. The main cohort was reactivated on July 18, 2018. The brain metastases cohort will remain open. The overall accrual target for S1416 has not changed.

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

Status:

Open

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

SWOG S1703

Primary Category:

Cancer Control and Prevention Protocols

Disease Category:

Breast, Breast Metastatic

Status:

Open

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

Eligible for screening study DCP 001

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

Status:

Open

Direct Oral Anticoagulants (DOACs) versus LMWH +/- Warfarin for VTE in Cancer: A Randomized Effectiveness Trial (CANVAS Trial)

NCT#02744092

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

Status:

Open

Electronic patient reporting of symptoms during outpatient cancer treatment: A U.S. national randomized controlled trial (the “PRO-TECT” trial)

NCT#03249090

Limited institution study – Only open to:  Billings Clinic & Bozeman Health

ALLIANCE A021602

Primary Category:

Treatment Protocols

Disease Category:

Carcinoid, Neuroendocrine, Pancreatic

Status:

Open

Randomized, Double-Blinded Phase III Study of CABozantinib Versus Placebo IN Patients with Advanced NEuroendocrine Tumors After Progression on Everolimus (CABINET)

NCT#03375320

Eligible for screening study DCP 001

ALLIANCE A221701

Primary Category:

Cancer Control and Prevention Protocols

Disease Category:

Breast, Gastrointestinal, Genitourinary, Neuroendocrine, Pancreatic, Renal

Status:

New, Open

Phase III Placebo-Controlled Trial to Evaluate Dexamethasone Use for Everolimus-Induced Oral Stomatitis: Prevention versus Early Treatment Approaches

NCT#03839940

Eligible for screening study DCP 001

ECOG-ACRIN EA2142

Primary Category:

Treatment Protocols

Disease Category:

Gastrointestinal, Neuroendocrine

Status:

Open

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

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

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

Status:

Open

Molecular Analysis for Therapy Choice (MATCH)

Eligible for screening study DCP 001

NCT#02465060

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

(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

Status:

New, Open

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

Other

ALLIANCE A011106

Primary Category:

Treatment Protocols

Disease Category:

Breast, Breast Neoadjuvant

Status:

Closed

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

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

Status:

Open

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

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

Status:

Closed

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

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

Disease Category:

Other

Status:

Open

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

Eligible for screening study DCP 001

DCP 001

Primary Category:

Cancer Control and Prevention Protocols

Disease Category:

Other

Status:

Open

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

Status:

Closed

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

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

Status:

Closed

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

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

Status:

Open

Molecular Analysis for Therapy Choice (MATCH)

Eligible for screening study DCP 001

NCT#02465060

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

(http://ecog-acrin.org/nci-match-eay131-designated-labs)

ECOG-ACRIN EAY131-Z1K

Primary Category:

Treatment Protocols

Disease Category:

Molecular Profiling, Other

Status:

New, Open

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

ECOG-ACRIN EAY131-Z1L

Primary Category:

Treatment Protocols

Disease Category:

Molecular Profiling, Other

Status:

New, Open

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

NCI 9671

Primary Category:

Cancer Control and Prevention Protocols

Disease Category:

Molecular Profiling, Other

Status:

Closed

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

NRG B-51

Primary Category:

Radiation Oncology, Treatment Protocols

Disease Category:

Breast, Breast Neoadjuvant

Status:

Open

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

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

Status:

Closed

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

NRG B-55

Primary Category:

Treatment Protocols

Disease Category:

Adjuvant Breast, Breast, Breast Neoadjuvant

Status:

Closed

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

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.

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

Status:

New, Open

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

SWOG S1701

Primary Category:

Treatment Protocols

Disease Category:

Other

Status:

New, Open

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

SWOG S1702

Primary Category:

Treatment Protocols

Disease Category:

Other

Status:

Open

A Phase II Study of Isatuximab (SAR650984) for Patients with Previously Treated AL Amyloidosis

NCT#03499808

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

Status:

Open

Direct Oral Anticoagulants (DOACs) versus LMWH +/- Warfarin for VTE in Cancer: A Randomized Effectiveness Trial (CANVAS Trial)

NCT#02744092

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

Status:

Open

Electronic patient reporting of symptoms during outpatient cancer treatment: A U.S. national randomized controlled trial (the “PRO-TECT” trial)

NCT#03249090

Limited institution study – Only open to:  Billings Clinic & Bozeman Health

ALLIANCE A091401

Primary Category:

Treatment Protocols

Disease Category:

Sarcoma

Status:

Closed

Randomized Phase II Study of Nivolumab with or Without Ipilimumab in Patients with Metastatic or Unresectable Sarcoma

NCT#02500797

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

Status:

Closed

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

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

Status:

Open

Molecular Analysis for Therapy Choice (MATCH)

Eligible for screening study DCP 001

NCT#02465060

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

(http://ecog-acrin.org/nci-match-eay131-designated-labs)

NRG DT001

Primary Category:

Radiation Oncology, Treatment Protocols

Disease Category:

Sarcoma

Status:

Open

A Phase Ib Trial of Neoadjuvant AMG-232 Concurrent with Preoperative Radiotherapy in Wild-Type P53 Soft Tissue Sarcoma (STS)

NCT#03217266

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

Status:

New, Open

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

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

Status:

Open

Direct Oral Anticoagulants (DOACs) versus LMWH +/- Warfarin for VTE in Cancer: A Randomized Effectiveness Trial (CANVAS Trial)

NCT#02744092

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

Status:

Open

Electronic patient reporting of symptoms during outpatient cancer treatment: A U.S. national randomized controlled trial (the “PRO-TECT” trial)

NCT#03249090

Limited institution study – Only open to:  Billings Clinic & Bozeman Health

ALLIANCE A091605

Primary Category:

Radiation Oncology, Treatment Protocols

Disease Category:

Skin

Status:

Open

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

ALLIANCE A091802

Primary Category:

Treatment Protocols

Disease Category:

Skin

Status:

New, Open

Phase II Randomized Trial of Avelumab Plus Cetuximab Versus Avelumab Alone in Advanced Cutaneous Squamous Cell Carcinoma of the Skin (cSCC)

NCT#03944941

ECOG-ACRIN E3612

Primary Category:

Treatment Protocols

Disease Category:

Melanoma, Metastatic Melanoma, Skin

Status:

Closed

A Randomized Phase II Trial of Ipilimumab with or without Bevacizumab in Patients with Unresectable Stage III or Stage IV Melanoma

NCT#01950390

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

Status:

Open

DREAMseq (Doublet, Randomized Evaluation in Advanced Melanoma Sequencing) a Phase III Trial

Eligible for screening study DCP 001

NCT#02224781

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

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

Disease Category:

Skin

Status:

New, Open

A Phase III Randomized Trial Comparing Adjuvant MK-3475 (Pembrolizumab) to Standard of Care Observation in Completely Resected Merkel Cell Carcinoma

NCT#03712605

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

Status:

Closed

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

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

Status:

Open

Molecular Analysis for Therapy Choice (MATCH)

Eligible for screening study DCP 001

NCT#02465060

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

(http://ecog-acrin.org/nci-match-eay131-designated-labs)

SWOG S1404

Primary Category:

Treatment Protocols

Disease Category:

Melanoma, Skin

Status:

Closed

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

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

Status:

Open

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

SWOG S1607

Primary Category:

Treatment Protocols

Disease Category:

Melanoma, Metastatic Melanoma, Skin

Status:

Open

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

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

Status:

New, Open

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

SWOG S1616

Primary Category:

Treatment Protocols

Disease Category:

Melanoma, Metastatic Melanoma, Skin

Status:

Open

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

SWOG S1801

Primary Category:

Treatment Protocols

Disease Category:

Melanoma, Metastatic Melanoma, Skin

Status:

New, Open

A Phase II Randomized Study of Adjuvant Versus NeoAdjuvant MK-3475 (Pembrolizumab) for Clinically Detectable Stage III-IV High-Risk Melanoma

NCT#03698019

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

Status:

Open

Electronic patient reporting of symptoms during outpatient cancer treatment: A U.S. national randomized controlled trial (the “PRO-TECT” trial)

NCT#03249090

Limited institution study – Only open to:  Billings Clinic & Bozeman Health

ALLIANCE A091305

Primary Category:

Treatment Protocols

Disease Category:

Thyroid

Status:

Closed

A Phase 2 Study of Efatutazone, an Oral PPAR Agonist, In Combination with Paclitaxel in Patients with Advanced Anaplastic Thyroid Cancer

NCT#02152137

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

Status:

New, Open

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