AFT-25 COMET
Primary Category:
Radiation Oncology, Surgical Protocols, Treatment Protocols
Disease Category:
Breast, Breast DCIS
Comparison of Operative to Monitoring and Endocrine Therapy (COMET) Trial For Low Risk DCIS: A Phase III Prospective Randomized Trial
NCT#02926911
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
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
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
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
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
Randomization to the fulvestrant arm (Arm 2) and the anastrozole + fulvestrant arm (Arm 3) will be closed to new patient accrual on 11/01/2018; accrual to these two arms has been met per protocol. Beginning on 11/01/2018 all new patients registered to A011106 will be registered to the anastrozole arm (Arm 1).
ALLIANCE A011202
Primary Category:
Radiation Oncology, Surgical Protocols, Treatment Protocols
Disease Category:
Adjuvant Breast, Breast
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
NCT#01901094
ALLIANCE A011203
Primary Category:
Treatment Protocols
Disease Category:
Breast, Breast Metastatic
A Randomized Phase II Trial of Tamoxifen Versus Z-Endoxifen HCL in Postmenopausal Women with Metastatic Estrogen Receptor Positive, HER2 Negative Breast Cancer
NCT#02311933
A011203 will soon meet its accrual goal. Therefore, EFFECTIVE MONDAY, April 17, 2017 at 4:30 pm ET, A011203 Pre-registration will permanently close to new patient accrual.
ALLIANCE A011401
Primary Category:
Cancer Control and Prevention Protocols
Disease Category:
Adjuvant Breast, Breast, Breast Neoadjuvant
Randomized Phase III Trial Evaluating the Role of Weight Loss in Adjuvant Treatment of Overweight and Obese Women with Early Breast Cancer
Eligible for screening study DCP 001
NCT#02750826
The A011401 Health Behaviors and Patient Reported Outcomes substudy HO1 will soon meet its study accrual goal. Therefore, EFFECTIVE July 06, 2017 at 4:30 pm ET, A011401 substudy HO1 will permanently close to new patient accrual.
ALLIANCE A011502
Primary Category:
Cancer Control and Prevention Protocols, Treatment Protocols
Disease Category:
Adjuvant Breast, Breast
A Randomized Phase III Double-Blinded Placebo Controlled Trial of Aspirin as Adjuvant Therapy for Node Positive HER2 Negative Breast Cancer: The ABC Trial
See Companion Study A211601
Eligible for screening study DCP 001
NCT#02927249
ALLIANCE A021502
Primary Category:
Treatment Protocols
Disease Category:
Colon, Gastrointestinal
Randomized Trial of Standard Chemotherapy Alone or Combined with Atezolizumab as Adjuvant Therapy for Patients with Stage III Colon Cancer and Deficient DNA Mismatch Repair
Eligible for screening study DCP 001
NCT#02912559
Site Delegation of Tasks Log required prior to registration of any patients.
ALLIANCE A021602
Primary Category:
Treatment Protocols
Disease Category:
Carcinoid, Neuroendocrine, Pancreatic
Randomized, Double-Blinded Phase III Study of CABozantinib Versus Placebo IN Patients with Advanced NEuroendocrine Tumors After Progression on Everolimus (CABINET)
NCT#03375320
Eligible for screening study DCP 001
ALLIANCE A031102
Primary Category:
Treatment Protocols
Disease Category:
Genitourinary
A Randomized Phase III Trial Comparing Conventional-Dose Chemotherapy Using Paclitaxel, Ifosfamide, and Cisplatin (TIP) with High-Dose Chemotherapy Using Mobilizing Paclitaxel Plus Ifosfamide Followed by High-Dose Carboplatin and Etoposide (TI-CE) as First Salvage Treatment in Relapsed or Refractory Germ Cell Tumors
Eligible for screening study DCP 001
NCT#02375204
ALLIANCE A031201
Primary Category:
Treatment Protocols
Disease Category:
Genitourinary, Prostate, Prostate Metastatic
Phase III Trial of Enzalutamide (NSC #766085) versus Enzalutamide, Abiraterone and Prednisone for Castration Resistant Metastatic Prostate Cancer
A031201 will soon meet its accrual goal. Therefore, effective August 31, 2016 at 4:30 PM ET, A031201 will be permanently closed to new patient accrual.
NCT#01949337
ALLIANCE A031203
Primary Category:
Treatment Protocols
Disease Category:
Genitourinary, Renal, Renal Metastatic
Randomized Phase II Study Comparing Cabozantinib (NSC #761968 and IND #116059) with Commercially Supplied Sunitinib in Patients with Previously Untreated Locally Advanced or Metastatic Renal Cell Carcinoma
Effective Monday, April 6th, 2015 at 4:30 PM (ET), Alliance A031203 permanently closed to new patient accrual.
NCT#01835158
ALLIANCE A031501
Primary Category:
Treatment Protocols
Disease Category:
Bladder, Genitourinary
Phase III Randomized Adjuvant study of MK-3475 (Pembrolizumab) in muScle invaSive and locAlly aDvanced urOthelial caRcinoma (AMBASSADOR) Versus Observation
NCT#03244384
Eligible for screening study DCP 001
ALLIANCE A031701
Primary Category:
Treatment Protocols
Disease Category:
Bladder, Genitourinary
A Phase II Study of Dose-Dense Gemcitabine Plus Cisplatin (ddGC) in Patients with Muscle-Invasive Bladder Cancer with Bladder Preservation for Those Patients Whose Tumors Harbor Deleterious DNA Damage Response (DDR) Gene Alterations
NCT#03609216
ALLIANCE A041202
Primary Category:
Treatment Protocols
Disease Category:
Chronic Lymphocytic Leukemia, Leukemia
A Randomized Phase III Study Of Bendamustine PLUS Rituximab Versus Ibrutinib Plus Rituximab Versus Ibrutinib Alone In Untreated Older Patients (≥ 65 Years Of Age) With Chronic Lymphocytic Leukemia (CLL)
A041202 will soon meet its accrual goal. Therefore, EFFECTIVE MONDAY, DECEMBER 28, 2015 at 4:30 pm ET, A041202 will permanently close to new patient pre-registration (Step 0).
A041202 has met its accrual goal. Therefore, EFFECTIVE MONDAY, May 16, 2016 at 4:30 pm ET, A041202 will permanently close to new patient registration (Step 1).
NCT#01886872
ALLIANCE A041501
Primary Category:
Treatment Protocols
Disease Category:
Acute Lymphocytic Leukemia, Leukemia
A Phase III Trial to Evaluate the Efficacy of the Addition of Inotuzumab Ozogamicin (a Conjugated Anti-CD22 Monoclonal Antibody) to Frontline Therapy in Young Adults (Ages 18-39 Years) with Newly Diagnosed Precursor B-Cell ALL
NCT#03150693
Eligible for screening study DCP 001
ALLIANCE A041701
Primary Category:
Treatment Protocols
Disease Category:
Acute Myeloid Leukemia, Leukemia
Status:
New, Upcoming - Pending IRB Review
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, Upcoming - Pending IRB Review
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
ALLIANCE A051301
Primary Category:
Treatment Protocols
Disease Category:
Diffuse Large B-cell Lymphoma, Lymphoma, Non-Hodgkin Lymphoma
Status:
Temporarily Closed
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
EFFECTIVE IMMEDIATELY, Friday, August 24, 2018, A051301 will be temporarily
suspended to new patient pre-registration (Step 0). Eligible patients who are currently
pre-registered may proceed to registration (Step 1).
Site Delegation of Tasks Log required prior to registration of any patients.
ALLIANCE A061402
Primary Category:
Cancer Control and Prevention Protocols, Treatment Protocols
Disease Category:
Multiple Myeloma, Other
Solitary Plasmacytoma of Bone: Randomized Phase III Trial to Evaluate Treatment with Adjuvant Systemic Treatment and Zoledronic Acid Versus Zoledronic Acid After Definite Radiation Therapy
Eligible for screening study DCP 001
NCT#02516423
Effective IMMEDIATELY, November 27, 2018, Alliance A061402 will permanently close to new patient pre-registration.
ALLIANCE A071102
Primary Category:
Treatment Protocols
A Phase II/III Randomized Trial Of Veliparib Or Placebo In Combination With Adjuvant
Temozolomide In Newly Diagnosed Glioblastoma With MGMT Promoter Hypermethylation
The study has accrued the sufficient number of patients to meet the enrollment goal. Therefore, effective Monday, October 15, 2018 Alliance A071102 will be permanently closed to new patient registration (Step 1).
The phase III portion of A071102 will soon meet its accrual goal. Therefore, EFFECTIVE Friday, May 18, 2018 at 4:00 PM ET, A071102 will be PERMANENTLY CLOSED to new patient pre-registration (Step 0).
NCT#02152982
ALLIANCE A071401
Primary Category:
Treatment Protocols
Status:
Temporarily Closed
Phase II Trial of SMO / AKT / NF2 Inhibitors in Progressive Meningiomas with SMO / AKT / NF2 Mutations
The A071401 NF2 Grade I and NF2 Grade II/III cohorts have met their accrual goals. Therefore, EFFECTIVE 07/19/17, no new patients may register (Step 1) to the NF2 Grade I or Grade II/III cohorts.
NCT#02523014
Effective immediately on 02/07/18, pre-registration (Step 0) and registration (Step 1) to A071401 have been temporarily suspended. The manufacturer of the investigational agent vismodegib has discontinued provision to new patients on A071401. Therefore, effectively immediately, the SMO/PTCH1 Grade I and SMO/PTCH1 Grade II/III cohorts on A071401 are closed to new patient registration (Step 1).
ALLIANCE A071601
Primary Category:
Treatment Protocols
Phase II Trial of BRAF/MEK Inhibitors in Papillary Craniopharyngiomas
NCT#03224767
ALLIANCE A081105
Primary Category:
Treatment Protocols
Disease Category:
Lung, Lung - Non-Small Cell, Molecular Profiling
Randomized Double Blind Placebo Controlled Study of Erlotinib or Placebo in Patients with Completely Resected Epidermal Growth Factor Receptor (EGFR) Mutant Non-Small Cell Lung Cancer (NSCLC)
(See required screening study ALLIANCE A151216)
Eligible for screening study DCP 001
NCT#02193282
ALLIANCE A091305
Primary Category:
Treatment Protocols
Disease Category:
Thyroid
A Phase 2 Study of Efatutazone, an Oral PPAR Agonist, In Combination with Paclitaxel in Patients with Advanced Anaplastic Thyroid Cancer
NCT#02152137
ALLIANCE A091401
Primary Category:
Treatment Protocols
Disease Category:
Sarcoma
Status:
Temporarily Closed
Randomized Phase II Study of Nivolumab with or Without Ipilimumab in Patients with Metastatic or Unresectable Sarcoma
NCT#02500797
Alliance A091401 has pre-registered a sufficient number of patients in all cohorts to meet its enrollment goal. Therefore, EFFECTIVE IMMEDIATELY, Wednesday, September 5, 2018, A091401 will be temporarily suspended to enrollment until further notice. Patients who are currently pre-registered can proceed to registration, if eligible.
As of Update #06, patient enrollment will be facilitated using the Slot Reservation System. Prior to discussing protocol entry with the patient, all site staff must contact MCC to ensure that a slot on the correct cohort is available to the patient. Once a slot reservation confirmation is obtained, site staff may then proceed to consent and pre-register the patient. Once a patient is pre-registered, specimens should be submitted for central pathology review. There will be no renewal of slots for this protocol. Therefore, pre registration must be completed within 7 calendar days of slot reservation.
As of 05/31/18 the GIST cohort has no remaining slots for patient registrations.
ALLIANCE A091404
Primary Category:
Treatment Protocols
Disease Category:
Head and Neck
A Phase II Study of Enzalutamide (NSC# 766085) for Patients with Androgen Receptor Positive Salivary Cancers
NCT#02749903
Effective August 31, 2018, Alliance A091404 is closed to accrual.
ALLIANCE A091605
Primary Category:
Radiation Oncology, Treatment Protocols
A Randomized Phase II Study of Anti-PD1 Antibody [MK-3475 (Pembrolizumab)] Alone Versus Anti-PD1 Antibody Plus Stereotactic Body Radiation Therapy in Advanced Merkel Cell Carcinoma
NCT#03304639
ALLIANCE A151216
Primary Category:
Treatment Protocols
Disease Category:
Lung, Lung - Non-Small Cell, Molecular Profiling
Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial (ALCHEMIST)
A screening trial for A081105, E4512, and EA5142.
Eligible for screening study DCP 001
NCT#02194738
ALLIANCE A171601
Primary Category:
Treatment Protocols
Disease Category:
Breast, Breast Metastatic
A Phase II Trial Assessing the Tolerability of Palbociclib in Combination with Letrozole or Fulvestrant in Patients Aged 70 and Older with Estrogen Receptor-Positive, HER2-Negative Metastatic Breast Cancer
NCT#03633331
Eligible for screening study DCP 001
ALLIANCE A211401
Primary Category:
Cancer Control and Prevention Protocols, Surgical Protocols
Disease Category:
Lung, Lung - Non-Small Cell, Lung - Small Cell
Reducing Surgical Complications in Newly Diagnosed Lung Cancer Patients Who Smoke Cigarettes
NCT#02856581
ALLIANCE A211601
Primary Category:
Cancer Control and Prevention Protocols
Disease Category:
Adjuvant Breast, Breast
Evaluation of Mammographic Breast Density Effect of Aspirin: A Companion to Alliance Study A011502
NCT#03609021
Eligible for screening study DCP 001
ALLIANCE A221208
Primary Category:
Cancer Control and Prevention Protocols, Radiation Oncology
Disease Category:
Brain Metastatic
Randomized Phase II Study: Corticosteroids and Bevacizumab vs. Corticosteroids and Placebo (BeSt) for Radionecrosis after Radiosurgery for Brain Metastases
The Alliance Data Safety Monitoring Board has directed that A221208 be closed due to poor accrual, as it is unlikely to reach its accrual goal. Therefore, EFFECTIVE Wednesday, November 21, 2018, at 4:30 pm ET, A221208 will permanently close to new patient pre-registration. Patients who are screened and consented need to be pre-registered on or before November 21, 2018. Sites will not be allowed pre-register new patients after this date.
Eligible for screening study DCP 001
NCT#02490878
ALLIANCE A221405
Primary Category:
Cancer Control and Prevention Protocols, Treatment Protocols
Disease Category:
Adjuvant Breast, Breast
Pregnancy Outcome and Safety of Interrupting Therapy for women with endocrine responsIVE breast cancer
NCT#02308085
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 A221504
Primary Category:
Cancer Control and Prevention Protocols
Disease Category:
Lung, Lung - Non-Small Cell, Lung - Non-Small Cell Metastatic
A Randomized, Double-Blind, Placebo-Controlled Pilot Study of an Oral, Selective Peripheral Opioid Receptor Antagonist in Advanced Non-Small Cell Lung Cancer (Adenocarcinoma)
NCT#03087708
Eligible for screening study DCP 001
ALLIANCE A221505
Primary Category:
Radiation Oncology, Surgical Protocols
Disease Category:
Adjuvant Breast, Breast
Phase III Randomized Trial of Hypofractionated Post Mastectomy Radiation with Breast Reconstruction
NCT#03414970
Eligible for screening study DCP 001
ALLIANCE A221602
Primary Category:
Cancer Control and Prevention Protocols
Olanzapine With or Without Fosaprepitant for the Prevention of Chemotherapy Induced Nausea and Vomiting (CINV)in Patients Receiving Highly Emetogenic Chemotherapy (HEC): A Phase III Randomized, Double Blind, Placebo-Controlled Trial
NCT#03578081
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, Upcoming - Pending IRB Review
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, Upcoming - Pending IRB Review
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 C140503
Primary Category:
Surgical Protocols
Disease Category:
Lung, Lung - Non-Small Cell
A Phase III Randomized Trial of Lobectomy versus Sublobar Resection for Small (≤ 2 cm)
Peripheral Non-Small Cell Lung Cancer
(See Section 9.0 for required surgical credentialing.)
NCT#00499330
C140503 has met its accrual goal. Therefore, effective Monday, March 13, 2017 at 4:30 pm EDT, CALGB 140503 will permanently close to new patient pre-registration. Patients that have been pre-registered on or before March 13, 2017 may continue the process to be registered.
ALLIANCE C30610
Primary Category:
Radiation Oncology, Treatment Protocols
Disease Category:
Lung, Lung - Small Cell, Lung - Small Cell Limited Stage
Phase III Comparison of Thoracic Radiotherapy Regimens in Patients with Limited Small Cell Lung Cancer Also Receiving Cisplatin and Etoposide
Eligible for screening study DCP 001
NCT#00632853
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.
ALLIANCE C50904
Primary Category:
Treatment Protocols
Disease Category:
Follicular Lymphoma, Lymphoma, Non-Hodgkin Lymphoma
A Randomized Phase II Trial of Ofatumumab and Bendamustine VS. Ofatumumab, Bortezomib (NSC #681239, IND #58443) and Bendamustine in Patients with Untreated Follicular Lymphoma
(See Section 11.0 for required PET/CT credentialing.)
CALGB 50904 has met its accrual goal. Therefore, effective Tuesday, April 5, 2016 at 4:30 PM ET, CALGB 50904 will permanently close to new patient accrual.
NCT#01286272
ALLIANCE C70807
Primary Category:
Cancer Control and Prevention Protocols
Disease Category:
Genitourinary, Prostate
The Men’s Eating and Living (MEAL)Study: A Randomized Trial of Diet to Alter Disease Progression in Prostate Cancer Patients on Active Surveillance
CALGB 70807 has enrolled sufficient patients to the pre-registration step of the study to meet the registration/randomization accrual goal. Therefore, effective Friday, August 14, 2015 at 5:00 PM ET, CALGB 70807 will be permanently closed to new patient pre-registrations.
NCT#01238172
ALLIANCE C80702
Primary Category:
Treatment Protocols
Disease Category:
Colon, Gastrointestinal
A Phase III Trial of 6 versus 12 Treatments of Adjuvant FOLFOX Plus Celecoxib or Placebo for Patients With Resected Stage III Colon Cancer
CALGB/SWOG 80702 is nearing its accrual goal. Therefore, effective Friday, November 20th, 2015 at 4:30 PM ET, CALGB/SWOG 80702 will permanently close to new patient accrual.
NCT#01150045
ALLIANCE C80803
Primary Category:
Radiation Oncology, Treatment Protocols
Disease Category:
Esophageal, Gastrointestinal
Randomized Phase II Trial of PET Scan-Directed Combined Modality Therapy in Esophageal Cancer
CALGB 80803 has met its accrual goal. Therefore, effective Monday, May 11, 2015 at 4:30 PM (ET), CALGB 80803 will permanently close to new patient accrual.
NCT#01333033
ALLIANCE C90203
Primary Category:
Treatment Protocols
Disease Category:
Genitourinary, Prostate
A Randomized Phase III Study of Neoadjuvant Docetaxel and Androgen Deprivation Prior to Radical Prostatectomy versus Immediate Radical Prostatectomy in Patients with High-Risk, Clinically Localized Prostate Cancer
CALGB 90203 has met its accrual goal. Therefore, effective Friday, October 2nd, 2015 at 4:30 PM EST, CALGB 90203 will permanently close to new patient accrual.
NCT#00430183
ALLIANCE CCTG CE.7
Primary Category:
Radiation Oncology
Disease Category:
Brain, Brain Metastatic
A Phase III Trial of Stereotactic Radiosurgery Compared With Whole Brain Radiotherapy (WBRT) for 5-15 Brain Metastases
NCT#03550391
ALLIANCE N0392
Primary Category:
Cancer Control and Prevention Protocols
Assessment of Patient Satisfaction with Participation in Phase II/III NCCTG Clinical Trials
MCC is a legacy NCCTG institution and site must offer patient participation in N0392 QOL study prior to randomization on N0577 only.
ALLIANCE N0577
Primary Category:
Radiation Oncology, Treatment Protocols
Phase III Intergroup Study of Temozolomide Alone versus Radiotherapy with Concomitant and Adjuvant Temozolomide versus Radiotherapy with Adjuvant PCV Chemotherapy in Patients with 1p/19q Co-deleted Anaplastic Glioma
Eligible for screening study DCP 001
MCC is a legacy NCCTG institution and site must offer patient participation in N0392 QOL study prior to randomization on N0577. See N0392 protocol page for separate consent form and additional information.
NCT#00887146
ALLIANCE N1048
Primary Category:
Radiation Oncology, Treatment Protocols
Disease Category:
Gastrointestinal, Rectal
A Phase II/III Trial of Neoadjuvant FOLFOX with Selective Use of Combined Modality Chemoradiation versus Preoperative Combined Modality Chemoradiation for Locally Advanced Rectal Cancer Patients Undergoing Low Anterior Resection with Total Mesorectal Excision (PROSPECT)
Eligible for screening study DCP 001
NCT#01515787
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.
ALLIANCE Z11102
Primary Category:
Surgical Protocols
Impact of Breast Conservation Surgery on Surgical Outcomes and Cosmesis in Patients with Multiple Ipsilateral Breast Cancers (MIBC)
NCT#01556243
DCP 001
Primary Category:
Cancer Control and Prevention Protocols
Use of a Clinical Trial Screening Tool to Address Cancer Health Disparities in the NCI Community Oncology Research Program (NCORP)
ECOG-ACRIN E1305
Primary Category:
Treatment Protocols
Disease Category:
Head and Neck, Head and Neck Metastatic
A Phase III Randomized Trial of Chemotherapy with or Without Bevacizumab in Patients with Recurrent or Metastatic Head and Neck Cancer
NCT#00588770
ECOG-ACRIN E1411
Primary Category:
Treatment Protocols
Disease Category:
Lymphoma, Mantle Cell Lymphoma, Non-Hodgkin Lymphoma
Intergroup Randomized Phase II Four Arm Study In Patients With Previously Untreated Mantle Cell Lymphoma Of Therapy With: Arm A = Rituximab+ Bendamustine Followed By Rituximab Consolidation (RB → R); Arm B = Rituximab + Bendamustine + Bortezomib Followed By Rituximab Consolidation (RBV→ R), Arm C = Rituximab + Bendamustine Followed By Lenalidomide + Rituximab Consolidation (RB → LR) or Arm D = Rituximab Bendamustine + Bortezomib Followed By Lenalidomide + Rituximab Consolidation (RBV → LR)
E1411 is successfully approaching its accrual goal, therefore this study will be closed to accrual effective September 9, 2016 at 5:00pm ET.
NCT#01415752
ECOG-ACRIN E1412
Primary Category:
Treatment Protocols
Disease Category:
Diffuse Large B-cell Lymphoma, Lymphoma, Non-Hodgkin Lymphoma
Randomized Phase II Open Label Study of Lenalidomide R-CHOP (R2CHOP) vs RCHOP (Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone) in Patients with Newly Diagnosed Diffuse Large B Cell Lymphoma
E1412 is successfully approaching its accrual goal, therefore this study will be closed to Step 0 accrual effective January 17, 2017 at 5pm ET.
NCT#01856192
ECOG-ACRIN E1910
Primary Category:
Treatment Protocols
Disease Category:
Acute Lymphocytic Leukemia, Leukemia
A Phase III Randomized Trial of Blinatumomab for Newly Diagnosed BCR-ABL-negative B lineage Acute Lymphoblastic Leukemia in Adults
Eligible for screening study DCP 001
NCT#02003222
ECOG-ACRIN E1912
Primary Category:
Treatment Protocols
Disease Category:
Chronic Lymphocytic Leukemia, Leukemia
A Randomized Phase III Study of Ibrutinib (PCI-32765)-based Therapy vs Standard Fludarabine, Cyclophosphamide, and Rituximab (FCR) Chemoimmunotherapy in Untreated Younger Patients with Chronic Lymphocytic Leukemia (CLL)
E1912 will close to Accrual Effective June 9, 2016 at 5:00 pm ET due to reaching its accrual goal.
NCT#02048813
ECOG-ACRIN E1A11
Primary Category:
Treatment Protocols
Disease Category:
Multiple Myeloma
Randomized Phase III Trial of Bortezomib, LENalidomide and Dexamethasone (VRd) Versus Carfilzomib, Lenalidomide and Dexamethasone (CRd) Followed by Limited or Indefinite DURation Lenalidomide MaintenANCE in Patients with Newly Diagnosed Symptomatic Multiple Myeloma (ENDURANCE)
Eligible for screening study DCP 001
NCT#01863550
E1A11 is successfully approaching its accrual goal. Therefore, this study will close to accrual effective January 29, 2019 at 5:00pm ET. Only patients who have signed a consent to participate on or before 5:00 PM (ET) January 29, 2019 will be accepted. Consented patients must be registered on or before 5:00 PM (ET) February 5, 2019.
ECOG-ACRIN E2108
Primary Category:
Treatment Protocols
Disease Category:
Breast, Breast Metastatic, Breast Neoadjuvant
A Randomized Phase III Trial of the Value of Early Local Therapy for the Intact Primary Tumor in Patients with Metastatic Breast Cancer
E2108 is approaching its accrual goal. Therefore, this study closed to accrual effective July 23, 2015 at 5:00 p.m. EDT for Step 1 registrations. Patients already registered to Step 1 may continue the process to Step 2 randomization, however no new Step 1 registrations will be permitted after this date.
NCT#01242800
ECOG-ACRIN E2408
Primary Category:
Treatment Protocols
Disease Category:
Follicular Lymphoma, Lymphoma
A 3-Arm Randomized Phase II Trial of Bendamustine-Rituximab (BR) Followed by Rituximab vs Bortezomib-BR (BVR) Followed by Rituximab vs BR Followed by Lenalidomide/Rituximab in High Risk Follicular Lymphoma
NCT#01216683
ECOG-ACRIN E3612
Primary Category:
Treatment Protocols
Disease Category:
Melanoma, Metastatic Melanoma, Skin
A Randomized Phase II Trial of Ipilimumab with or without Bevacizumab in Patients with Unresectable Stage III or Stage IV Melanoma
NCT#01950390
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 E3A06
Primary Category:
Treatment Protocols
Disease Category:
Multiple Myeloma
Randomized Phase III Trial of Lenalidomide Versus Observation Alone in Patients with Asymptomatic High-Risk Smoldering Multiple Myeloma
NCT#01169337
E3A06 is successfully approaching its accrual goal. A pending closure date has been set for July 14, 2017 at 5:00pm ET for new patient registration.
ECOG-ACRIN E4412
Primary Category:
Treatment Protocols
Disease Category:
Hodgkin Lymphoma, Lymphoma
A Phase I Study with an Expansion Cohort/Randomized Phase II Study of the Combinations of Ipilimumab, Nivolumab and Brentuximab Vedotin in Patients with Relapsed/Refractory Hodgkin Lymphoma
NCT#01896999
Open to Phase II accrual.
ECOG-ACRIN E4512
Primary Category:
Treatment Protocols
Disease Category:
Lung, Lung - Non-Small Cell, Molecular Profiling
A Phase III Double-Blind Trial for Surgically Resected Early Stage Non-Small Cell Lung Cancer: Crizotinib versus Placebo for Patients with Tumors Harboring the Anaplastic Lymphoma Kinase (ALK) Fusion Protein
(See required screening study ALLIANCE A151216)
Eligible for screening study DCP 001
NCT#02201992
ECOG-ACRIN E5103
Primary Category:
Treatment Protocols
Disease Category:
Adjuvant Breast, Breast
A Double-Blind Phase III Trial of Doxorubicin and Cyclophosphamide followed by Paclitaxel with Bevacizumab or Placebo in Patients with Lymph Node Positive and High Risk Lymph Node Negative Breast Cancer
E5103 Step 3 registration, registration to the EL112LAB substudy, will close to accrual on July 29, 2016.
NCT#00433511
ECOG-ACRIN E5508
Primary Category:
Treatment Protocols
Disease Category:
Lung, Lung - Non-Small Cell, Lung - Non-Small Cell Metastatic
Randomized Phase III Study of Maintenance Therapy with Bevacizumab, Pemetrexed, or a Combination of Bevacizumab and Pemetrexed Following Carboplatin, Paclitaxel and Bevacizumab for Advanced Non-Squamous NSCLC
E5508 is approaching its Step 1 accrual goal. Therefore, this study will close Step 1 accrual effective May 8, 2015 at 5:00 p.m. EST for registrations. Patients registered to Step 1 by this time may still register to Step 2 as outlined in the protocol.
NCT#01107626
ECOG-ACRIN EA1131
Primary Category:
Treatment Protocols
Disease Category:
Adjuvant Breast, Breast
A Randomized Phase III Post-Operative Trial of Platinum Based Chemotherapy Vs. Capecitabine in Patients with Residual Triple-Negative Breast Cancer following Neoadjuvant Chemotherapy
Eligible for screening study DCP 001
NCT#02445391
ECOG-ACRIN EA2142
Primary Category:
Treatment Protocols
Disease Category:
Gastrointestinal, Neuroendocrine
Randomized Phase II Study of Cisplatin and Etoposide versus Temozolomide and Capecitabine in Patients with Advanced G3 Non-Small Cell Gastroenteropancreatic Neuroendocrine Carcinomas
NCT#02595424
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
A Randomized Phase II Study of Nivolumab After Combined Modality Therapy (CMT) in High Risk Anal Cancer
NCT#03233711
ECOG-ACRIN EA3132
Primary Category:
Radiation Oncology, Treatment Protocols
Disease Category:
Head and Neck
Phase II Randomized Trial of Adjuvant Radiotherapy with or Without Cisplatin for p53 Mutated, Surgically Resected Squamous Cell Carcinoma of the Head and Neck (SCCHN)
NCT#02734537
ECOG-ACRIN EA3163
Primary Category:
Radiation Oncology, Surgical Protocols, Treatment Protocols
Disease Category:
Head and Neck
Phase II randomized trial of neo-adjuvant chemotherapy followed by surgery and post-operative radiation versus surgery and post-operative radiation for organ preservation of T3 and T4a nasal and paranasal sinus squamous cell carcinoma (NPNSCC)
NCT#03493425
ECOG-ACRIN EA4151
Primary Category:
Treatment Protocols
Disease Category:
Lymphoma, Mantle Cell Lymphoma, Non-Hodgkin Lymphoma
A Randomized Phase III Trial of Consolidation with Autologous Hematopoietic Cell Transplantation Followed by Maintenance Rituximab vs Maintenance Rituximab Alone for Patients with Mantle Cell Lymphoma in Minimal Residual Disease-Negative First Complete Remission
NCT#03267433
Eligible for screening study DCP 001
ECOG-ACRIN EA5142
Primary Category:
Treatment Protocols
Disease Category:
Lung, Lung - Non-Small Cell, Molecular Profiling
Adjuvant Nivolumab in Resected Lung Cancers (ANVIL)-A Randomized Phase III Study of Nivolumab After Surgical Resection and Adjuvant Chemotherapy in Non-Small Cell Lung Cancers
(See required screening study ALLIANCE A151216)
Eligible for screening study DCP 001
NCT#02595944
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:
Temporarily 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 August 8th, 2018, EA5152 is temporarily suspended to accrual while a redesign of the study is being developed for chemo/immunotherapy refractory patients.
ECOG-ACRIN EA5161
Primary Category:
Treatment Protocols
Disease Category:
Lung, Lung - Small Cell, Lung - Small Cell Extensive Stage
Randomized Phase II Clinical Trial of Cisplatin/Carboplatin and Etoposide (CE) Alone or in Combination with Nivolumab as Frontline Therapy for Extensive Stage Small Cell Lung Cancer (ED-SCLC)
NCT#03382561
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
Phase II Study of AZD9291 (Osimertinib) in Advanced NSCLC Patients with Exon 20 Insertion Mutations in EGFR
NCT#03191149
ECOG-ACRIN EA6134
Primary Category:
Treatment Protocols
Disease Category:
Melanoma, Metastatic Melanoma, Skin
A Randomized Phase III trial of Dabrafenib + Trametinib followed by Ipilimumab + Nivolumab at Progression vs. Ipilimumab + Nivolumab followed by Dabrafenib + Trametinib at Progression in Patients With Advanced BRAFV600 Mutant Melanoma
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
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 EA8143
Primary Category:
Treatment Protocols
Disease Category:
Genitourinary, Renal
A Phase 3 RandOmized Study Comparing PERioperative Nivolumab vs. Observation in Patients with Localized Renal Cell Carcinoma Undergoing Nephrectomy (PROSPER RCC)
Eligible for screening study DCP 001
NCT#03055013
Site Delegation of Tasks Log required prior to registration of any patients.
ECOG-ACRIN EA8153
Primary Category:
Treatment Protocols
Disease Category:
Genitourinary, Prostate, Prostate Metastatic
Cabazitaxel with Abiraterone Versus Abiraterone Alone Randomized Trial for Extensive Disease Following Docetaxel: The CHAARTED2 Trial
NCT#03419234
ECOG-ACRIN EA8171
Primary Category:
Treatment Protocols
Disease Category:
Genitourinary, Prostate
Multiparametric MRI (mpMRI) for Preoperative Staging and Treatment Planning for Newly-Diagnosed Prostate Cancer
NCT#03697148
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 EA9161
Primary Category:
Treatment Protocols
Disease Category:
Chronic Lymphocytic Leukemia, Leukemia
Status:
New, Upcoming - Pending IRB Review
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
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 EAQ152
Primary Category:
Cancer Control and Prevention Protocols
Disease Category:
Brain, Breast, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Lung, Lymphoma, Melanoma, Molecular Profiling, Other, Sarcoma
COMET – Communication and Education in Tumor Profiling: A Randomized Study of Pre-disclosure Genetic Education v. Usual Care in Tumor Profiling for Advanced Cancer and a Pilot Study of Remote Genetic Counseling for Participants with Potential Germline Mutations Identified on Tumor Profiling
(Sub-study for EAY131)
Eligible for screening study DCP 001
NCT#02823652
MCC not eligible to participate in new addendum, as EAQ152 is only open to accrual at select sites.
ECOG-ACRIN EAQ162CD
Primary Category:
Cancer Care Delivery, Cancer Control and Prevention Protocols
Disease Category:
Cancer Care Delivery, Colon, Gastrointestinal, Rectal
Longitudinal Assessment of Financial Burden in Patients with Colon or Rectal Cancer Treated with Curative Intent
NCT#03516942
Eligible for screening study DCP 001
ECOG-ACRIN EAY131
Primary Category:
Treatment Protocols
Disease Category:
Brain, Breast, Carcinoid, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Lung, Lymphoma, Melanoma, Molecular Profiling, Other, Sarcoma
Molecular Analysis for Therapy Choice (MATCH)
Eligible for screening study DCP 001
NCT#02465060
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
- 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
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 Schema
ECOG-ACRIN EAY131-B
Primary Category:
Treatment Protocols
Disease Category:
Molecular Profiling
MATCH Treatment Subprotocol B: Phase II Study of Afatinib in Patients with Tumors with HER2 Activating Mutations
(See required screening study ECOG-ACRIN EAY131)
NCT#02465060
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
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
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
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)
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-G
Primary Category:
Treatment Protocols
Disease Category:
Molecular Profiling
MATCH Treatment Subprotocol G: Phase II Study of Crizotinib in Patients with ROS1 Translocations (Other Than Patients with Non-Small Cell Lung Cancer)
(See required screening study ECOG-ACRIN EAY131)
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-H
Primary Category:
Treatment Protocols
Disease Category:
Molecular Profiling
MATCH Treatment Subprotocol H: Phase II Study of Dabrafenib and Trametinib in Patients with Tumors with BRAF V600E or V600K Mutations (Excluding Melanoma and Thyroid Cancer)
(See required screening study ECOG-ACRIN EAY131)
Effective immediately, 06/15/18, EAY131-H is formally closed to accrual, as it has reached its enrollment goal.
NCT#02465060
ECOG-ACRIN EAY131-I
Primary Category:
Treatment Protocols
Disease Category:
Molecular Profiling
MATCH Treatment Subprotocol I: EAY131-I: GDC-0032 (taselisib) in Patients with Tumors (other than breast cancer) with PIK3CA mutation but without KRAS mutation or PTEN loss
(See required screening study ECOG-ACRIN EAY131)
NCT#02465060
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
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.
NCT#02465060
ECOG-ACRIN EAY131-K1
Primary Category:
Treatment Protocols
Disease Category:
Molecular Profiling
MATCH Treatment Subprotocol K1: Phase 2 Study of Erdafitinib (JNJ-42756493) in Patients with Tumors with FGFR Amplifications
(See required screening study ECOG-ACRIN EAY131)
Open to participants with results from one of the designated outside laboratories indicating a “rare variant that is an actionable Mutation of Interest (aMOI) for specific designated rare variant subprotocols. See Appendix XIV of the main protocol for a list of the designated laboratories and applicable subprotocols.
The consent form for this sub-study is available upon request when a patient at your site is assigned to the sub-study. Please contact Amber Boerner, aboerner@mtcancer.org or 406-969-6067, for the consent & for any questions.
EAY131 (MATCH) Subprotocol K1, or EAY131-K1, is nearing the completion of its accrual goal, and no available treatment assignment slots remain at this time.
NCT#02465060
ECOG-ACRIN EAY131-K2
Primary Category:
Treatment Protocols
Disease Category:
Molecular Profiling
MATCH Treatment Subprotocol K2: Phase 2 Study of Erdafitinib (JNJ-42756493) in Patients with Tumors with FGFR Mutations and Fusions
(See required screening study ECOG-ACRIN EAY131)
Open to participants with results from one of the designated outside laboratories indicating a “rare variant that is an actionable Mutation of Interest (aMOI) for specific designated rare variant subprotocols. See Appendix XIV of the main protocol for a list of the designated laboratories and applicable subprotocols.
The consent form for this sub-study is available upon request when a patient at your site is assigned to the sub-study. Please contact Amber Boerner, aboerner@mtcancer.org or 406-969-6067, for the consent & for any questions.
NCT#02465060
ECOG-ACRIN EAY131-L
Primary Category:
Treatment Protocols
Disease Category:
Molecular Profiling
MATCH Treatment Subprotocol L: Phase II Study of MLN0128 (TAK-228) in Patients with Tumors with mTOR Mutations
(See required screening study ECOG-ACRIN EAY131)
Open to participants with results from one of the designated outside laboratories indicating a “rare variant that is an actionable Mutation of Interest (aMOI) for specific designated rare variant subprotocols. See Appendix XIV of the main protocol for a list of the designated laboratories and applicable subprotocols.
The consent form for this sub-study is available upon request when a patient at your site is assigned to the sub-study. Please contact Amber Boerner, aboerner@mtcancer.org or 406-969-6067, for the consent & for any questions.
NCT#02465060
ECOG-ACRIN EAY131-M
Primary Category:
Treatment Protocols
Disease Category:
Molecular Profiling
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.
NCT#02465060
ECOG-ACRIN EAY131-N
Primary Category:
Treatment Protocols
Disease Category:
Molecular Profiling
MATCH Treatment Subprotocol N: EAY131-N: Phase II Study of PI3K Beta Specific Inhibitor, GSK2636771, in Patients with Tumors with PTEN Mutation or Deletion, with PTEN Expression on IHC
(See required screening study ECOG-ACRIN EAY131)
Effective immediately, 06/15/18, EAY131-N is formally closed to accrual for administrative reasons.
NCT#02465060
ECOG-ACRIN EAY131-P
Primary Category:
Treatment Protocols
Disease Category:
Molecular Profiling
MATCH Treatment Subprotocol P: EAY131-P: Phase II Study of PI3K Beta Specific Inhibitor, GSK2636771, in Patients with Tumors with PTEN Loss by IHC
(See required screening study ECOG-ACRIN EAY131)
NCT#02465060
Effective immediately, 06/15/18, EAY131-P is formally closed to accrual, as it has reached its enrollment goal.
ECOG-ACRIN EAY131-Q
Primary Category:
Treatment Protocols
Disease Category:
Molecular Profiling
MATCH Treatment Subprotocol Q: Ado-trastuzumab Emtansine in Patients with Tumors with HER2 Amplification (Except Breast and Gastric/Gastro-Esophageal Junction (GEJ) Adenocarcinomas)
(See required screening study ECOG-ACRIN EAY131)
NCT#02465060
Effective immediately, 06/15/18, EAY131-Q is formally closed to accrual, as it has reached its enrollment goal.
ECOG-ACRIN EAY131-R
Primary Category:
Treatment Protocols
Disease Category:
Molecular Profiling
MATCH Treatment Subprotocol R: Phase II Study of Trametinib in Patients with BRAF Fusions, or with Non-V600E, Non-V600K BRAF Mutations
(See required screening study ECOG-ACRIN EAY131)
NCT#02465060
Effective immediately, 06/15/18, EAY131-R is formally closed to accrual, as it has reached its enrollment goal.
ECOG-ACRIN EAY131-S1
Primary Category:
Treatment Protocols
Disease Category:
Molecular Profiling
MATCH Treatment Subprotocol S1: EAY131-S1: Phase II Study of Trametinib in Patients with Tumors with NF1 mutations
(See required screening study ECOG-ACRIN EAY131)
NCT#02465060
Effective immediately, 06/15/18, EAY131-S1 is formally closed to accrual, as it has reached its enrollment goal.
ECOG-ACRIN EAY131-S2
Primary Category:
Treatment Protocols
Disease Category:
Molecular Profiling
MATCH Treatment Subprotocol S2: EAY131-S2: Phase II Study of Trametinib in Patients with Tumors with GNAQ or GNA11 mutations
(See required screening study ECOG-ACRIN EAY131)
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-T
Primary Category:
Treatment Protocols
Disease Category:
Molecular Profiling
MATCH Treatment Subprotocol T: GDC-0449 (vismodegib) in Patients with Tumors (except basal cell skin carcinoma) with Smoothened (SMO) or Patched 1 (PTCH1) Mutations
(See required screening study ECOG-ACRIN EAY131)
Open to participants with results from one of the designated outside laboratories indicating a “rare variant that is an actionable Mutation of Interest (aMOI) for specific designated rare variant subprotocols. See Appendix XIV of the main protocol for a list of the designated laboratories and applicable subprotocols.
The consent form for this sub-study is available upon request when a patient at your site is assigned to the sub-study. Please contact Amber Boerner, aboerner@mtcancer.org or 406-969-6067, for the consent & for any questions.
NCT#02465060
ECOG-ACRIN EAY131-U
Primary Category:
Treatment Protocols
Disease Category:
Molecular Profiling
MATCH Treatment Subprotocol U: VS-6063 (defactinib) in Patients with Tumors with NF2 Loss
(See required screening study ECOG-ACRIN EAY131)
NCT#02465060
Effective immediately, 06/15/18, EAY131-U is formally closed to accrual, as it has reached its enrollment goal.
ECOG-ACRIN EAY131-V
Primary Category:
Treatment Protocols
Disease Category:
Molecular Profiling
MATCH Treatment Subprotocol V: Phase II Study of Sunitinib in Patients with Tumors with cKIT Mutations (Excluding GIST, Renal Cell Carcinoma or Pancreatic Neuroendocrine Tumor)
(See required screening study ECOG-ACRIN EAY131)
Open to participants with results from one of the designated outside laboratories indicating a “rare variant that is an actionable Mutation of Interest (aMOI) for specific designated rare variant subprotocols. See Appendix XIV of the main protocol for a list of the designated laboratories and applicable subprotocols.
The consent form for this sub-study is available upon request when a patient at your site is assigned to the sub-study. Please contact Amber Boerner, aboerner@mtcancer.org or 406-969-6067, for the consent & for any questions.
NCT#02465060
ECOG-ACRIN EAY131-W
Primary Category:
Treatment Protocols
Disease Category:
Molecular Profiling
MATCH Treatment Subprotocol W: Phase II Study of AZD4547 in Patients with Tumors with Aberrations in the FGFR Pathway
(See required screening study ECOG-ACRIN EAY131)
NCT#02465060
Effective immediately, 06/15/18, EAY131-W is formally closed to accrual, as it has reached its enrollment goal.
ECOG-ACRIN EAY131-X
Primary Category:
Treatment Protocols
Disease Category:
Molecular Profiling
MATCH Treatment Subprotocol X: EAY131-X: Phase II Study of Dasatinib in Patients with Tumors with DDR2 Mutations
(See required screening study ECOG-ACRIN EAY131)
Effective immediately, 06/15/18, EAY131-X is formally closed to accrual, as the prevalence rate for the mutation remains at zero.
NCT#02465060
ECOG-ACRIN EAY131-Y
Primary Category:
Treatment Protocols
Disease Category:
Molecular Profiling
MATCH Treatment Subprotocol Y: AZD5363 in Patients with Tumors with AKT Mutations
(See required screening study ECOG-ACRIN EAY131)
NCT#02465060
Effective immediately, 06/15/18, EAY131-Y is formally closed to accrual, as it has reached its enrollment goal.
ECOG-ACRIN EAY131-Z1A
Primary Category:
Treatment Protocols
Disease Category:
Molecular Profiling
MATCH Treatment Subprotocol Z1A: Binimetinib in Patients with Tumors (Other Than Melanoma) with NRAS Mutations
(See required screening study ECOG-ACRIN EAY131)
NCT#02465060
Effective immediately, 06/15/18, EAY131-Z1A is formally closed to accrual, as it has reached its enrollment goal.
ECOG-ACRIN EAY131-Z1B
Primary Category:
Treatment Protocols
Disease Category:
Molecular Profiling
MATCH Treatment Subprotocol Z1B: Phase II Study of Palbociclib (PD-0332991) in Patients with Tumors with CCND1, 2, 3 Amplification and Rb Protein Expression by IHC
(See required screening study ECOG-ACRIN EAY131)
NCT#02465060
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
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
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
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
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
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
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 NHLBI-MDS
Primary Category:
Cancer Control and Prevention Protocols
Disease Category:
Leukemia, Myelodysplastic Syndrome
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.
ECOG-ACRIN PACCT-1
Primary Category:
Treatment Protocols
Disease Category:
Adjuvant Breast, Breast
Program for the Assessment of Clinical Cancer Tests (PACCT-1): Trial Assigning Individualized Options for Treatment: The TAILORx Trial
Ancillary study EL112LAB for the PACCT1 Trial has reached its accrual goal. Therefore, PACCT1 Step 3 registration (EL112LAB) will be closed to accrual effective Friday, July 3, 2015 at 5:00 pm EST. (E5103 accrual remains open for EL112LAB.)
NCT#00310180
GOG Foundation GOG 3018/VB-111-701
Primary Category:
Treatment Protocols
Disease Category:
Gynecologic, Ovarian
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
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
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
NCI 9671
Primary Category:
Cancer Control and Prevention Protocols
Disease Category:
Molecular Profiling, Other
Exceptional Responders Pilot study: Molecular profiling of tumors from cancer patients who are exceptional responders
All cases must be provisionally approved by NCI, before enrollment. Once a case is approved by NCI, then the IRB approval process takes place.
Due to the completion of accrual, new case proposal assignments to this protocol will be terminated July 10, 2017. As of July 11, 2017 no new case proposals will be accepted.
NCT#02243592
NRG B-51
Primary Category:
Radiation Oncology, Treatment Protocols
Disease Category:
Breast, Breast Neoadjuvant
Randomized Phase III Clinical Trial Evaluating Post-Mastectomy Chestwall and Regional Nodal XRT and Post-Lumpectomy Regional Nodal XRT in Patients with Positive Axillary Nodes Before Neoadjuvant Chemotherapy Who Convert to Pathologically Negative Axillary Nodes After Neoadjuvant Chemotherapy
Eligible for screening study DCP 001
NCT#01872975
The accrual goal for the Behaviorial and Health Outcomes (BAHO) Quality of Life component in the B-51 trial has been met. Therefore, effective August 6th, 2018, accrual will be closed to the QoL component. The B-51 trial remains open to accrual.
NRG B-52
Primary Category:
Treatment Protocols
Disease Category:
Breast, Breast Neoadjuvant
A Randomized Phase III Trial Evaluating Pathologic Complete Response Rates in Patients with Hormone Receptor-Positive, HER2-Positive, Large Operable and Locally Advanced Breast Cancer Treated with Neoadjuvant Therapy of Docetaxel, Carboplatin, Trastuzumab, and Pertuzumab (TCHP) With or Without Estrogen Deprivation
B-52 will close to accrual, today, February 29, 2016, effective 8 pm EST. We realize that some patients who have consented to participate in the study will not have completed their pre-entry biopsy to obtain fresh tumor samples by today; therefore, patients who have signed the B-52 consent form on or before today, February 29, 2016, will be permitted to enter the study.
NCT#02003209
NRG B-55
Primary Category:
Treatment Protocols
Disease Category:
Adjuvant Breast, Breast, Breast Neoadjuvant
A Randomised, Double-Blind, Parallel Group, Placebo-Controlled Multi-Centre Phase III Study to Assess the Efficacy and Safety of Olaparib Versus Placebo as Adjuvant Treatment in Patients with Germline BRCA1/2 Mutations and High Risk HER2 Negative Primary Breast Cancer Who Have Completed Definitive Local Treatment and Neoadjuvant or Adjuvant Chemotherapy
Eligible for screening study DCP 001
NCT#02032823
NRG BN003
Primary Category:
Radiation Oncology, Treatment Protocols
Phase III Trial of Observation Versus Irradiation for a Gross Totally Resected Grade II Meningioma
Eligible for screening study DCP 001
NCT#03180268
NRG BR002
Primary Category:
Radiation Oncology, Treatment Protocols
Disease Category:
Breast, Breast Metastatic
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
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 BR005
Primary Category:
Treatment Protocols
Disease Category:
Breast, Breast Neoadjuvant
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
NRG CC001
Primary Category:
Radiation Oncology, Treatment Protocols
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
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 CC004
Primary Category:
Cancer Control and Prevention Protocols
Disease Category:
Breast, Gynecologic
Phase II Double Blind Dose Finding Trial of Bupropion Versus Placebo for Sexual Desire in Women with Breast or Gynecologic Cancer
Eligible for screening study DCP 001
NCT#03180294
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 DT001
Primary Category:
Radiation Oncology, Treatment Protocols
Disease Category:
Sarcoma
A Phase Ib Trial of Neoadjuvant AMG-232 Concurrent with Preoperative Radiotherapy in Wild-Type P53 Soft Tissue Sarcoma (STS)
NCT#03217266
NRG G0212
Primary Category:
Treatment Protocols
Disease Category:
GYN Other, Gynecologic, Ovarian
A Randomized Phase III Trial of Maintenance Chemotherapy Comparing 12, Monthly Cycles of Single Agent Paclitaxel or CT-2103 (IND # 70177), Versus No Treatment Until Documented Relapse in Women with Advanced Ovarian, Primary Peritoneal or Fallopian Tube Cancer Who Achieve a Complete Clinical Response to Primary Platinum/Taxane Chemotherapy
NRG G0225
Primary Category:
Cancer Control and Prevention Protocols
Disease Category:
Gynecologic
Can Diet and Physical Activity Modulate Ovarian, Fallopian Tube and Primary Peritoneal Cancer Progression-Free Survival?
G0225 will close to accrual effective Friday, August 24, 2018, because it will have reached its accrual target. Until then, please limit accrual to patients who are already in the screening process.
NCT#00719303
Eligible for screening study DCP 001
NRG G0237
Primary Category:
Cancer Control and Prevention Protocols
Disease Category:
GYN Other
Comparative Analysis of CA-IX, p16, Proliferative Markers, and Human Papilloma Virus (HPV) in the Diagnosis of Significant Cervical Lesions in Patients with a Cytologic Diagnosis of Atypical Glandular Cells (AGC)
NCT#00892866
Eligible for screening study DCP 001
NRG G0263
Primary Category:
Radiation Oncology, Treatment Protocols
Disease Category:
Cervical, Gynecologic
Randomized Phase III Clinical Trial of Adjuvant Radiation Versus Chemoradiation in Intermediate Risk, Stage I/IIA Cervical Cancer Treated with Initial Radical Hysterectomy and Pelvic Lymphadenectomy
Eligible for screening study DCP 001
NCT#01101451
NRG G0270
Primary Category:
Radiation Oncology, Surgical Protocols, Treatment Protocols
Disease Category:
Gynecologic
GROningen INternational Study on Sentinel nodes in Vulvar cancer (GROINSS-V) II
NCT#01500512
NRG G0274
Primary Category:
Radiation Oncology, Treatment Protocols
Disease Category:
Cervical, Gynecologic
A Phase III Trial of Adjuvant Chemotherapy Following Chemoradiation as Primary Treatment for Locally Advanced Cervical Cancer Compared to Chemoradiation Alone: The Outback Trial
Eligible for screening study DCP 001
NCT#01414608
Please be aware that as of the 1st June 2017, sites are no longer permitted to screen for or provide informed consent forms for potential OUTBACK/GOG274/RTOG1174 patients as the protocol has reached its accrual goal.
NRG G0281
Primary Category:
Treatment Protocols
Disease Category:
Gynecologic, Ovarian
A Randomized Phase II/III Study to Assess the Efficacy of Trametinib (GSK 1120212) in Patients with Recurrent or Progressive Low-Grade Serous Ovarian Cancer or Peritoneal Cancer
NCT#02101788
G0281 has met its target accrual goal in the U.S. and the study is no longer accepting any additional specimens for screening. Closure notice to follow soon.
NRG G0286B
Primary Category:
Treatment Protocols
Disease Category:
Endometrial, Endometrial Metastatic, Gynecologic
A Randomized Phase II/III Study of Paclitaxel/Carboplatin/Metformin (NSC#91485) Versus Paclitaxel/Carboplatin/Placebo as Initial Therapy for Measurable Stage III or IVA, Stage IVB, or Recurrent Endometrial Cancer
NCT#02065687
GOG-0286B will be permanently closed to accrual effective today, February 1, 2018 due to futility.
NRG GI002
Primary Category:
Radiation Oncology, Treatment Protocols
Disease Category:
Gastrointestinal, Rectal
A Phase II Clinical Trial Platform of Sensitization Utilizing Total Neoadjuvant Therapy (TNT) in Rectal Cancer
NCT#02921256
NRG GI004
Primary Category:
Treatment Protocols
Disease Category:
Colon, Colon Metastatic, Gastrointestinal, Rectal, Rectal Metastatic
Colorectal Cancer Metastatic dMMR Immuno-Therapy (COMMIT) Study: A Randomized Phase III Study of mFOLFOX6/Bevacizumab Combination Chemotherapy with or without Atezolizumab or Atezolizumab Monotherapy in the First-Line Treatment of Patients with Deficient DNA Mismatch Repair (dMMR) Metastatic Colorectal Cancer
Eligible for screening study DCP 001
NCT#02997228
Site Delegation of Tasks Log required prior to registration of any patients.
NRG GU002
Primary Category:
Radiation Oncology, Treatment Protocols
Disease Category:
Genitourinary, Prostate
Phase II-III Trial of Adjuvant Radiotherapy and Androgen Deprivation Following Radical Prostatectomy With or Without Adjuvant Docetaxel
NCT#03070886
NRG GU003
Primary Category:
Radiation Oncology, Treatment Protocols
Disease Category:
Genitourinary, Prostate
A Randomized Phase III Trial of Hypofractionated Post-Prostatectomy Radiation Therapy (HYPORT) versus Conventional Post-Prostatectomy Radiation Therapy (COPORT)
Eligible for screening study DCP 001
GU003 will close to accrual at 5 PM ET Monday, July 9, 2018, because it has reached its accrual target. All patients registered to Step 1 registration by Monday, July 9, 2018 will be permitted to proceed to the randomization step (Step 2).
NRG GU005
Primary Category:
Radiation Oncology
Disease Category:
Genitourinary, Prostate
Phase III IGRT and SBRT Vs IGRT and Hypofractionated IMRT for Localized Intermediate Risk Prostate Cancer
Eligible for screening study DCP 001
NCT#03367702
*RT Credentialing Required
**Because the AJCC staging version 8 was not ready for the study activation, AJCC staging version 7 must be used.
NRG GU006
Primary Category:
Radiation Oncology, Treatment Protocols
Disease Category:
Genitourinary, Prostate, Prostate Recurrent
A Phase II, Double-Blinded, Placebo-Controlled Randomized Trial of Salvage Radiotherapy with or Without Enhanced Anti-Androgen Therapy with Apalutamide in Recurrent Prostate Cancer
NCT#03371719
NRG GY004
Primary Category:
Treatment Protocols
Disease Category:
Gynecologic, Ovarian
A Phase III study comparing single-agent olaparib or the combination of cediranib and olaparib to standard platinum-based chemotherapy in women with recurrent platinum sensitive ovarian, fallopian tube, or primary peritoneal cancer
NCT#02446600
Closed to accrual effective November 10, 2017. Accrual goal met.
This protocol has additional regulatory requirements to be completed prior to registering any patients at your site. Please contact Amber Boerner at 406-969-6067 or aboerner@mtcancer.org for additional information.
NRG GY005
Primary Category:
Treatment Protocols
Disease Category:
Gynecologic, Ovarian
A Randomized Phase II/III study of the combination of Cediranib and Olaparib compared to Cediranib or Olaparib alone, or Standard of care chemotherapy in women with recurrent platinum-resistant or -refractory ovarian, fallopian tube, or primary peritoneal cancer (COCOS)
NCT#02502266
Reactivated to accrual on Phase III with Amendment #7, 01/02/19.
This protocol has additional regulatory requirements to be completed prior to registering any patients at your site. Please contact Amber Boerner at 406-969-6067 or aboerner@mtcancer.org for additional information.
NRG GY006
Primary Category:
Radiation Oncology, Treatment Protocols
Disease Category:
Cervical, Gynecologic
A Randomized Phase II 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 GY008
Primary Category:
Treatment Protocols
Disease Category:
Endometrial, Gynecologic
A Phase II Evaluation of Copanlisib (BAY 80-6946) (IND#130822), A Selective Inhibitor of PI3KCA, in Patients with Persistent or Recurrent Endometrial Carcinoma Harboring PIK3CA Hotspot Mutations
NCT#02728258
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
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
Currently open to Phase II accrual.
NRG GY011
Primary Category:
Surgical Protocols
Disease Category:
Endometrial, Gynecologic
A Randomized Surgical Window Pilot Investigation of the Relationship of Short Term Medroxyprogesterone Acetate (NSC #26386) Compared to Medroxyprogesterone Acetate Plus Entinostat (NSC #706995) on the Morphologic, Biochemical, and Molecular Changes in Primary Endometrioid Adenocarcinoma of the Uterine Corpus
NCT#03018249
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:
New, 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
NRG-GY012 will suspend to accrual effective 02/04/19 due to a planned formal safety review.
NRG GY016
Primary Category:
Treatment Protocols
Disease Category:
Gynecologic, Ovarian
A Phase II Study of MK-3475 (Pembrolizumab) (NSC #776864) + Epacadostat (NSC #766086) in Recurrent Clear Cell Carcinoma of the Ovary
NCT#03602586
NRG HN002
Primary Category:
Radiation Oncology, Treatment Protocols
Disease Category:
Head and Neck
A Randomized Phase II Trial for Patients with p16 Positive, Non-Smoking Associated, Locoregionally Advanced Oropharyngeal Cancer
NCT#02254278
Closed effective 02/07/17. Accrual goal met.
NRG HN004
Primary Category:
Radiation Oncology, Treatment Protocols
Disease Category:
Head and Neck
Status:
Temporarily Closed
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 LU001
Primary Category:
Radiation Oncology, Treatment Protocols
Disease Category:
Lung, Lung - Non-Small Cell
Randomized Phase II Trial of Concurrent Chemoradiotherapy +/- Metformin HCL in Locally Advanced NSCLC
LU001 is closed effective December 15, 2016 because it has reached its accrual target.
NCT#02186847
NRG LU002
Primary Category:
Radiation Oncology, Treatment Protocols
Disease Category:
Lung, Lung - Non-Small Cell, Lung - Non-Small Cell Metastatic
Maintenance Systemic Therapy Versus Consolidative Stereotactic Body Radiation Therapy (SBRT) Plus Maintenance Systemic Therapy for Limited Metastatic Non-Small Cell Lung Cancer (NSCLC): A Randomized Phase II/III Trial
NCT#03137771
NRG LU004
Primary Category:
Radiation Oncology, Treatment Protocols
Disease Category:
Lung, Lung - Non-Small Cell
Status:
New, Upcoming - Pending IRB Review
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 R0521
Primary Category:
Radiation Oncology, Treatment Protocols
Disease Category:
Genitourinary, Prostate
A Phase III Protocol of Androgen Suppression (AS) and 3DCRT/IMRT vs AS and 3DCRT/IMRT Followed by Chemotherapy with Docetaxel and Prednisone for Localized, High-Risk Prostate Cancer
NRG R0534
Primary Category:
Radiation Oncology, Treatment Protocols
Disease Category:
Genitourinary, Prostate, Prostate Recurrent
A Phase III Trial of Short Term Androgen Deprivation with Pelvic Lymph Node or Prostate Bed Only Radiotherapy (SPPORT) in Prostate Cancer Patients with a Rising PSA After Radical Prostatectomy
NCT#00567580
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 R0724
Primary Category:
Radiation Oncology, Treatment Protocols
Disease Category:
Cervical, Gynecologic
Phase III Randomized Study of Concurrent Chemotherapy and Pelvic Radiation Therapy with or without Adjuvant Chemotherapy in High-Risk Patients with Early-Stage Cervical Carcinoma Following Radical Hysterectomy
Eligible for screening study DCP 001
NCT#00980954
NRG R0815
Primary Category:
Radiation Oncology, Treatment Protocols
Disease Category:
Genitourinary, Prostate
A Phase III Prospective Randomized Trial of Dose-Escalated Radiotherapy with or without Short-Term Androgen Deprivation Therapy for Patients with Intermediate-Risk Prostate Cancer
R0815 will close to accrual at 5 PM EST on Monday, March 7, 2016, because the study has reached its accrual target.
NCT#00936390
NRG R0848
Primary Category:
Radiation Oncology, Treatment Protocols
Disease Category:
Gastrointestinal, Pancreatic
A Phase II-R and A Phase III Trial Evaluating Both Erlotinib (Ph II-R) and Chemoradiation (Ph III) as Adjuvant Treatment for Patients with Resected Head of Pancreas Adenocarcinoma
NCT#01013649
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 R0920
Primary Category:
Radiation Oncology, Treatment Protocols
Disease Category:
Head and Neck
A Phase III Study of Postoperative Radiation Therapy (IMRT) +/- Cetuximab for Locally-Advanced Resected Head and Neck Cancer
Eligible for screening study DCP 001
NCT#00956007
R0920 is closed to accrual as of 5 PM ET Tuesday, March 27, 2018, because it has reached its accrual target.
NRG R0924
Primary Category:
Radiation Oncology, Treatment Protocols
Disease Category:
Genitourinary, Prostate
Androgen Deprivation Therapy and High Dose Radiotherapy with or Without Whole-Pelvic Radiotherapy in Unfavorable Intermediate or Favorable High Risk Prostate Cancer: A Phase III Randomized Trial
(QOL Sub-study is closed as its accrual goal has been met.)
Eligible for screening study DCP 001
NCT#02673190
NRG R1008
Primary Category:
Radiation Oncology, Treatment Protocols
Disease Category:
Head and Neck
A Randomized Phase II/Phase III Study of Adjuvant Concurrent Radiation and Chemotherapy Versus Radiation Alone in Resected High-Risk Malignant Salivary Gland Tumors
NCT#01220583
NRG R1010
Primary Category:
Radiation Oncology, Treatment Protocols
Disease Category:
Esophageal, Gastrointestinal
A Phase III Trial Evaluating the Addition of Trastuzumab to Trimodality Treatment of HER2-Overexpressing Esophageal Adenocarcinoma
R1010 will close to STEP 1 registration at 5 PM EST on Tuesday, November 10, 2015, because the study has reached its accrual target. STEP 2 registration will remain open and all eligible patients determined to be HER2 positive will be permitted to be randomized for treatment on this trial.
NCT#01196390
NRG R1201
Primary Category:
Radiation Oncology, Treatment Protocols
Disease Category:
Gastrointestinal, Pancreatic
A Phase II Randomized Trial Evaluating the Addition of High or Standard Intensity Radiation to Gemcitabine and Nab-Paclitaxel for Locally Advanced Pancreatic Cancer
R1201 is permanently closed to accrual, effective immediately, June 30, 2016. After an accrual assessment by CTEP it was determined that the trial would not be completed within a reasonable timeframe per CTEP’s Early Phase Trial Slow Accrual guidelines. Please note there are no increased safety risks that led to this decision of closure. Study-specific follow-up and data submission will cease for all patients.
NCT#01921751
NRG R1203
Primary Category:
Radiation Oncology, Treatment Protocols
Disease Category:
Cervical, Endometrial, Gynecologic
A Randomized Phase III Study of Standard vs. IMRT Pelvic Radiation for Post-Operative Treatment of Endometrial and Cervical Cancer (TIME-C)
NRG 1203 closed to accrual at 5 PM EST Thursday, August 27, 2015 because it had reached its accrual target.
NCT#01672892
NRG R1306
Primary Category:
Radiation Oncology, Treatment Protocols
Disease Category:
Lung, Lung - Non-Small Cell
A Randomized Phase II Study of Individualized Combined Modality Therapy for Stage III Non-Small Cell Lung Cancer (NSCLC)
NCT#01822496
R1306 will close to accrual at 5 PM EST Wednesday, December 20, 2017, because we were unable to meet the projected accrual goals due to low prevalence of patients with EGFR mutant and ALK translocation tumors.
SWOG LUNGMAP
Primary Category:
Treatment Protocols
Disease Category:
Lung, Lung - Non-Small Cell, Lung - Non-Small Cell Metastatic
A Master Protocol to Evaluate Biomarker-Driven Therapies and Immunotherapies in Previously-Treated Non-Small Cell Lung Cancer (Lung-MAP Screening Study)
Eligible for screening study DCP 001
SWOG S0931
Primary Category:
Treatment Protocols
Disease Category:
Genitourinary, Renal
EVEREST: EVErolimus for Renal Cancer Ensuing Surgical Therapy, A Phase III Study
S0931 has met its accrual goal and will permanently close to accrual effective September 15, 2016 at 11:59 p.m. Pacific Time.
NCT#01120249
SWOG S1007
Primary Category:
Treatment Protocols
Disease Category:
Adjuvant Breast, Breast
A Phase III, Randomized Clinical Trial of Standard Adjuvant Endocrine Therapy +/- Chemotherapy in Patients with 1-3 Positive Nodes, Hormone Receptor-Positive and HER2-Negative Breast Cancer with Recurrence Score (RS) of 25 or Less. RxPONDER: A Clinical Trial Rx for Positive Node, Endocrine Responsive Breast Cancer
S1007 will be permanently closed to accrual for Step 1 registration effective October 1, 2015 at 11:59 p.m. PST. The study will be permanently closed to accrual for Step 2 registration effective October 15, 2015 at 11:59 p.m. PST. Patients who will be registered to Step 1 and Step 2 at the same time (patients whose Recurrence Score is already known) must be registered prior to closure of Step 1
registration on October 1, 2015.
NCT#01272037
SWOG S1203
Primary Category:
Treatment Protocols
Disease Category:
Acute Myeloid Leukemia, Leukemia
A Randomized Phase III Study of Standard Cytarabine Plus Daunorubicin (7+3) Therapy or Idarubicin with High Dose Cytarabine (IA) Versus IA with Vorinostat (NSC-701852) (IA+V) in Younger Patients with Previously Untreated Acute Myeloid Leukemia (AML)
S1203 is fast-approaching its accrual goal and will permanently close to accrual effective November 4, 2015 at 11:59 pm Pacific Time.
NCT#01802333
SWOG S1207
Primary Category:
Treatment Protocols
Disease Category:
Adjuvant Breast, Breast
Phase III Randomized, Placebo-Controlled Clinical Trial Evaluating the Use of Adjuvant Endocrine Therapy +/- One Year of Everolimus in Patients with High-Risk, Hormone Receptor-Positive and HER2/neu Negative Breast Cancer. e^3 Breast Cancer Study-Evaluating Everolimus with Endocrine Therapy
NCT#01674140
Eligible for screening study DCP 001
SWOG S1216
Primary Category:
Treatment Protocols
Disease Category:
Genitourinary, Prostate, Prostate Metastatic
A Phase III Randomized Trial Comparing Androgen Deprivation Therapy + TAK-700 with Androgen Deprivation Therapy + Bicalutamide in Patients with Newly Diagnosed Metastatic Hormone Sensitive Prostate Cancer
NCT#01809691
S1216 has met its accrual goal and will permanently close to accrual effective July 15, 2017 at 11:59 p.m. Pacific.
SWOG S1304
Primary Category:
Treatment Protocols
Disease Category:
Multiple Myeloma
A Phase II Randomized Study Comparing Two Doses of Carfilzomib (NSC-756640) with Dexamethasone for Multiple Myeloma Patients with Relapsed or Refractory Disease
S1304 was temporarily closed to accrual on November 6, 2015. It was anticipated that the study would be re-opened to accrual (subsequent to an accrual target increase due to a higher than anticipated ineligibility rate). It has since been determined that the accrual target increase is not necessary for endpoint assessment. This study is now permanently closed to accrual, effective immediately.
NCT#01903811
SWOG S1314
Primary Category:
Treatment Protocols
Disease Category:
Bladder, Genitourinary
A Randomized Phase II Study of CO-eXpression ExtrapolatioN (COXEN) with Neoadjuvant Chemotherapy for Localized, Muscle-Invasive Bladder Cancer
NCT#02177695
S1314 has met its accrual goal and will permanently close to accrual effective December 1, 2017 at 11:59 p.m. Pacific.
SWOG S1320
Primary Category:
Treatment Protocols
Disease Category:
Melanoma, Metastatic Melanoma, Skin
A Randomized Phase II Trial of Intermittent Versus Continuous Dosing of Dabrafenib (NSC-763760) and Trametinib (NSC-763093) in BRAF V600E/K Mutant Melanoma
NCT#02196181
SWOG S1400
Primary Category:
Treatment Protocols
Disease Category:
Lung, Lung - Non-Small Cell, Lung - Non-Small Cell Metastatic, Molecular Profiling
A Biomarker-Driven Master Protocol for Previously Treated Squamous Cell Lung Cancer
Eligible for screening study DCP 001
NCT#02154490
Closure to accrual for S1400 will be effective 2:00 p.m. Pacific Time on January 28, 2019.
SWOG S1400A
Primary Category:
Treatment Protocols
Disease Category:
Lung, Lung - Non-Small Cell, Lung - Non-Small Cell Metastatic, Molecular Profiling
A Phase II Study of MEDI4736 for Previously Treated Patients with Stage IV Squamous Cell Lung Cancer and No Matching Biomarkers (Lung-MAP Sub-Study)
(See required screening study SWOG S1400)
Permanent Closure of S1400A, Arm 2-Docetaxel due to FDA approval of nivolumab. Permanent closure of sub-study due to a revised trial design.
NCT#02154490
SWOG S1400B
Primary Category:
Treatment Protocols
Disease Category:
Lung, Lung - Non-Small Cell, Lung - Non-Small Cell Metastatic, Molecular Profiling
A Phase II Study of GDC-0032 (Taselisib) for Previously Treated PI3K Positive Patients with Stage IV Squamous Cell Lung Cancer (Lung-MAP Sub-Study)
(See required screening study SWOG S1400)
S1400B is closed to accrual effective December 12, 2016, as the study did not meet the criterion for the interim futility analysis.
NCT#02154490
SWOG S1400C
Primary Category:
Treatment Protocols
Disease Category:
Lung, Lung - Non-Small Cell, Lung - Non-Small Cell Metastatic, Molecular Profiling
A Phase II Study of Palbociclib for Previously Treated Cell Cycle Gene Alteration Positive Patients with Stage IV Squamous Cell Lung Cancer (Lung-MAP Sub-Study)
(See required screening study SWOG S1400)
Permanent closure of Arm 2 ONLY due to a revised trial design.
S1400C will be permanently closed to accrual, effective September 1, 2016, as the study did not meet the criterion for the interim futility analysis.
NCT#02154490
SWOG S1400D
Primary Category:
Treatment Protocols
Disease Category:
Lung, Lung - Non-Small Cell, Lung - Non-Small Cell Metastatic, Molecular Profiling
A Phase II Study of AZD4547 for Previously Treated FGFR-Positive Patients with Stage IV Squamous Cell Lung Cancer (Lung-MAP Sub-Study)
(See required screening study SWOG S1400)
Effective 11:59 p.m. Pacific Time on October 31, 2016, the following sub-study will be permanently closed to accrual, as the study did not meet the criterion for the interim futility analysis.
NCT#02154490
SWOG S1400E
Primary Category:
Treatment Protocols
Disease Category:
Lung, Lung - Non-Small Cell, Lung - Non-Small Cell Metastatic, Molecular Profiling
A Phase II/III Randomized Study of Rilotumumab Plus Erlotinib Versus Erlotinib as Second Line Therapy for C-MET Positive Patients with Stage IV Squamous Cell Lung Cancer (Lung-Map Sub-Study)
(See required screening study SWOG S1400)
NCT#02154490
SWOG S1400F
Primary Category:
Treatment Protocols
Disease Category:
Lung, Lung - Non-Small Cell, Lung - Non-Small Cell Metastatic, Molecular Profiling
A Phase II Study of MEDI4736 (Durvalumab) plus Tremelimumab as Therapy for Patients with Previously Treated ANTIPD-1/PD-L1 Resistant Stage IV Squamous Cell Lung Cancer (Lung-MAP Non-Match Sub-Study)
See Screening Protocol LUNGMAP
NCT#02154490
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.
SWOG S1400G
Primary Category:
Treatment Protocols
Disease Category:
Lung, Lung - Non-Small Cell, Lung - Non-Small Cell Metastatic, Molecular Profiling
A Phase II Study of Talazoparib (BMN 673) in Patients with Homologous Recombination Repair Deficiency Positive Stage IV Squamous Cell Lung Cancer (Lung-MAP Sub-Study)
(See required screening study SWOG S1400)
NCT#02154490
Effective July 23, 2018, the following sub-study, S1400G, will be permanently closed.
SWOG S1400I
Primary Category:
Treatment Protocols
Disease Category:
Lung, Lung - Non-Small Cell, Lung - Non-Small Cell Metastatic, Molecular Profiling
A Phase III Randomized Study of Nivolumab Plus Ipilimumab Versus Nivolumab for Previously Treated Patients with Stage IV Squamous Cell Lung Cancer and No Matching Biomarker (Lung-MAP Sub-Study)
Eligible for screening study DCP 001
(See required screening study SWOG S1400)
NCT#02154490
S1400I is permanently closed to accrual effective immediately, 04/23/18. At a planned interim analysis, SWOG’s Data and Safety Monitoring Committee recommended that sub study S1400I be permanently closed to accrual based on the results. This information will be shared and further instructions given in a forthcoming letter to patients and investigators. Patients currently receiving the experimental combination nivolumab plus ipilimumab may continue to receive treatment if the patient is deriving clinical benefit, the patient agrees to continue treatment, and if their physician feels that it is in the best interest of the patient to continue the treatment as an appropriate medical intervention at this time. Patients on both arms should continue study follow-up.
SWOG S1400K
Primary Category:
Treatment Protocols
Disease Category:
Lung, Lung - Non-Small Cell, Lung - Non-Small Cell Metastatic, Molecular Profiling
A Phase II Study of ABBV-399 (Process II) in Patients with
c-Met Positive Stage IV or Recurrent Squamous Cell Lung Cancer
(Lung-MAP Sub-Study)
S1400K will be temporarily closed to accrual 10/18/18 based on additional review of the safety data.
At a planned interim analysis, the study team reviewed patient data to date and did not find that every 3-week dosing of ABBV-399 was sufficiently active to continue enrolling patient to the study. S1400K will be permanently closed, on 12/21/18, to accrual based on the results.
(See required screening study SWOG S1400)
NCT#02154490
SWOG S1403
Primary Category:
Treatment Protocols
Disease Category:
Lung, Lung - Non-Small Cell, Lung - Non-Small Cell Metastatic
Randomized Phase II/III Trial of Afatinib Plus Cetuximab Versus Afatinib Alone in Treatment-Naive Patients with Advanced, EGFR Mutation Positive Non-Small Cell Lung Cancer (NSCLC)
NCT#02438722
S1403 is permanently closed to accrual effective immediately, 04/23/18. Additional information is forthcoming.
SWOG S1404
Primary Category:
Treatment Protocols
Disease Category:
Melanoma, Skin
A Phase III Randomized Trial Comparing Physician/Patient Choice of High Dose Interferon or Ipilimumab to MK-3475 (Pembrolizumab) in Patients with High Risk Resected Melanoma
Eligible for screening study DCP 001
NCT#02506153
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 S1415CD
Primary Category:
Cancer Care Delivery, Cancer Control and Prevention Protocols
Disease Category:
Cancer Care Delivery
A Pragmatic Trial Evaluating a Colony Stimulating Factor Intervention in Standing Orders and the Effectiveness of Colony Stimulating Factor Use as Prophylaxis for Patients Receiving Chemotherapy with Intermediate Risk for Febrile Neutropenia
Limited site participation. Open only to Billings Clinic and Bozeman Health
NCT#02728596
Eligible for screening study DCP 001
SWOG S1416
Primary Category:
Treatment Protocols
Disease Category:
Breast, Breast Metastatic
Phase II Randomized Placebo-Controlled Trial of Cisplatin with or Without ABT-888 (Veliparib) in Metastatic Triple-Negative Breast Cancer and/or BRCA Mutation-Associated Breast Cancer
NCT#02595905
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.
SWOG S1417CD
Primary Category:
Cancer Care Delivery, Cancer Control and Prevention Protocols
Disease Category:
Cancer Care Delivery, Colon, Colon Metastatic, Gastrointestinal, Rectal, Rectal Metastatic
Implementation of a Prospective Financial Impact Assessment Tool in Patients with Metastatic Colorectal Cancer
NCT#02728804
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 S1418
Primary Category:
Treatment Protocols
Disease Category:
Adjuvant Breast, Breast
A Randomized, Phase III Trial to Evaluate the Efficacy and Safety of MK-3475 as Adjuvant Therapy for Triple Receptor-Negative Breast Cancer with > 1 cm Residual Invasive Cancer or Positive Lymph Nodes (ypN+) After Neoadjuvant Chemotherapy
Eligible for screening study DCP 001
NCT#02954874
Site Delegation of Tasks Log required prior to registration of any patients.
SWOG S1500
Primary Category:
Treatment Protocols
Disease Category:
Renal, Renal Metastatic
A Randomized, Phase II Efficacy Assessment of Multiple MET Kinase Inhibitors (Cabozantinib [NSC #761968], Crizotinib [NSC #749005], Savolitinib [NSC #785348], and Sunitinib [NSC #736511]) in Metastatic Papillary Renal Carcinoma (PAPMET)
NCT#02761057
Partial permanent closure for Arm 3 and Arm 4 effective 12/05/18.
SWOG S1501
Primary Category:
Cancer Control and Prevention Protocols
Disease Category:
Breast, Breast Metastatic
Prospective Evaluation of Carvedilol in Prevention of Cardiac Toxicity in Patients with Metastatic HER-2+ Breast Cancer, Phase III
Eligible for screening study DCP 001
SWOG S1505
Primary Category:
Treatment Protocols
Disease Category:
Gastrointestinal, Pancreatic
A Randomized Phase II Study of Perioperative mFOLFIRINOX versus Gemcitabine/nab-Paclitaxel as Therapy for Resectable Pancreatic Adenocarcinoma
NCT#02562716
S1505 will be permanently closed to accrual effective April 20, 2018 at 11:59 p.m. Pacific Time.
SWOG S1507
Primary Category:
Treatment Protocols
Disease Category:
Lung, Lung - Non-Small Cell, Lung - Non-Small Cell Metastatic
A Phase II Trial of Trametinib with Docetaxel in Patients with Kras Mutation Positive Non-Small Cell Lung Cancer (NSCLC) and Progressive Disease Following One or Two Prior Systemic Therapies
NCT#02642042
S1507 has met its accrual goal and will permanently close to accrual effective March 15, 2018 at 11:59 p.m. Pacific.
SWOG S1512
Primary Category:
Treatment Protocols
Disease Category:
Melanoma, Skin
A Phase II and Pilot Trial of PD-1 Blockade with MK-3475 (Pembrolizumab) in Patients with Resectable or Unresectable Desmoplastic Melanoma (DM)
NCT#02775851
SWOG S1513
Primary Category:
Treatment Protocols
Disease Category:
Gastrointestinal, Pancreatic, Pancreatic Metastatic
Randomized Phase II Study of 2nd Line FOLFIRI versus Modified FOLFIRI with PARP Inhibitor ABT-888 (Veliparib) (NSC-737664) in Metastatic Pancreatic Cancer
NCT#02890355
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 S1602
Primary Category:
Treatment Protocols
Disease Category:
Bladder, Genitourinary
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
Phase II Trial of Atezolizumab in BCG-Unresponsive Non-Muscle Invasive Bladder Cancer
NCT#02844816
SWOG S1607
Primary Category:
Treatment Protocols
Disease Category:
Melanoma, Metastatic Melanoma, Skin
A Phase II Study of Combining T-VEC (NSC-785349) and Pembrolizumab (NSC-776864) in Patients with Advanced Melanoma Who Have Progressed on Anti-PD1/L1 Based Therapy
NCT#02965716
Limited institution study: open only to Billings Clinic
SWOG S1608
Primary Category:
Treatment Protocols
Disease Category:
Follicular Lymphoma, Lymphoma, Non-Hodgkin Lymphoma
Randomized Phase II Trial in Early Relapsing or Refractory Follicular Lymphoma
NCT#03269669
SWOG S1609
Primary Category:
Treatment Protocols
Disease Category:
Molecular Profiling
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.
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 S1613
Primary Category:
Treatment Protocols
Disease Category:
Colon, Colon Metastatic, Gastrointestinal, Rectal, Rectal Metastatic
A Randomized Phase II Study of Trastuzumab and Pertuzumab (TP) Compared to Cetuximab and Irinotecan (CETIRI) in Advanced/Metastatic Colorectal Cancer (MCRC) with HER-2 Amplification
NCT#03365882
SWOG S1616
Primary Category:
Treatment Protocols
Disease Category:
Melanoma, Metastatic Melanoma, Skin
A Phase II Randomized Study of Nivolumab (NSC-748726) with Ipilimumab (NSC-732442) OR Ipilimumab Alone in Advanced Melanoma Patients Refractory to an Anti-PD-1 or Anti PD-L1 Agent
NCT#03033576
SWOG S1619
Primary Category:
Radiation Oncology, Surgical Protocols, Treatment Protocols
Disease Category:
Lung, Mesothelioma
A Feasibility Trial of Neoadjuvant Cisplatin-Pemetrexed with Atezolizumab in Combination and in Maintenance for Resectable Malignant Pleural Mesothelioma
NCT#03228537
Eligible for screening study DCP 001
SWOG S1701
Primary Category:
Treatment Protocols
A Randomized Phase II Trial of Carboplatin-Paclitaxel with or Without Ramucirumab in Patients with Unresectable Locally Advanced, Recurrent, or Metastatic Thymic Carcinoma
NCT#03694002
SWOG S1702
Primary Category:
Treatment Protocols
A Phase II Study of Isatuximab (SAR650984) for Patients with Previously Treated AL Amyloidosis
NCT#03499808
SWOG S1703
Primary Category:
Cancer Control and Prevention Protocols
Disease Category:
Breast, Breast Metastatic
Randomized Non-Inferiority Trial Comparing Overall Survival of Patients Monitored with Serum Tumor Marker Directed Disease Monitoring (STMDDM) versus Usual Care in Patients with Metastatic Hormone Receptor Positive Breast Cancer
NCT#03723928
Eligible for screening study DCP 001
SWOG S1706
Primary Category:
Treatment Protocols
A Phase II Randomized Trial of Olaparib (NSC-747856) Administered Concurrently with Radiotherapy Versus Radiotherapy Alone for Inflammatory Breast Cancer
NCT#03598257
SWOG S1712
Primary Category:
Treatment Protocols
Disease Category:
Chronic Myeloid Leukemia, Leukemia
A Randomized Phase II Study of Ruxolitinib (NSC-752295) in Combination with BCR-ABL Tyrosine Kinase Inhibitors in Chronic Myeloid Leukemia (CML) Patients with Molecular Evidence of Disease
NCT#03654768
SWOG S1801
Primary Category:
Treatment Protocols
Disease Category:
Melanoma, Metastatic Melanoma, Skin
A Phase II Randomized Study of Adjuvant Versus NeoAdjuvant MK-3475 (Pembrolizumab) for Clinically Detectable Stage III-IV High-Risk Melanoma
NCT#03698019
SWOG S1802
Primary Category:
Radiation Oncology, Surgical Protocols, Treatment Protocols
Disease Category:
Genitourinary, Prostate, Prostate Metastatic
Phase III Randomized Trial of Standard Systemic Therapy (SST) Versus Standard Systemic Therapy Plus Definitive Treatment (Surgery or Radiation) of the Primary Tumor in Metastatic Prostate Cancer
NCT#03678025
Eligible for screening study DCP 001
SWOG S1815
Primary Category:
Treatment Protocols
Disease Category:
Cholangiocarcinoma, Gallbladder, Gastrointestinal
A Phase III Randomized Trial of Gemcitabine, Cisplatin, and Nab-Paclitaxel Versus Gemcitabine and Cisplatin in Newly Diagnosed, Advanced Biliary Tract Cancers
NCT#03768414
SWOG S1900A
Primary Category:
Treatment Protocols
Disease Category:
Lung, Lung - Non-Small Cell, Lung - Non-Small Cell Metastatic
A Phase II Study of Rucaparib in Patients with Genomic LOH High and/or Deleterious BRCA1/2 Mutation Stage IV or Recurrent Non-Small Cell Lung Cancer (LUNG-MAP Sub-Study)
See Screening Protocol LUNGMAP
