AFT-25 COMET

Primary Category:

Radiation Oncology, Surgical Protocols, Treatment Protocols

Disease Category:

Breast, Breast DCIS

Status:

New, Upcoming - Pending IRB Review

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

AFT-28 CANVAS

Primary Category:

Cancer Control and Prevention Protocols

Disease Category:

Brain, Breast, Chronic Lymphocytic Leukemia, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Lung, Lymphoma, Melanoma, Multiple Myeloma, Neuroendocrine, Sarcoma

Status:

New, Upcoming - Pending IRB Review

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

ALLIANCE A011104

Primary Category:

Cancer Control and Prevention Protocols

Disease Category:

Breast

Status:

Open

Effect of Preoperative Breast MRI on Surgical Outcomes, Costs and Quality of Life of Women With Breast Cancer Eligible for screening study DCP 001

ALLIANCE A011106

Primary Category:

Treatment Protocols

Disease Category:

Breast, Breast Neoadjuvant

Status:

Open

ALTernate approaches for clinical stage II or III Estrogen Receptor positive breast cancer NeoAdjuvant TrEatment (ALTERNATE) in postmenopausal women: A Phase III Study  

ALLIANCE A011202

Primary Category:

Radiation Oncology, Surgical Protocols, Treatment Protocols

Disease Category:

Adjuvant Breast, Breast

Status:

Open

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  

ALLIANCE A011203

Primary Category:

Treatment Protocols

Disease Category:

Breast, Breast Metastatic

Status:

Closed

A Randomized Phase II Trial of Tamoxifen Versus Z-Endoxifen HCL in Postmenopausal Women with Metastatic Estrogen Receptor Positive, HER2 Negative Breast Cancer A011203 will soon meet its accrual goal.  Therefore, EFFECTIVE MONDAY, April 17, 2017 at 4:30 pm ET, A011203 Pre-registration will permanently close to new patient accrual.

ALLIANCE A011401

Primary Category:

Cancer Control and Prevention Protocols

Disease Category:

Adjuvant Breast, Breast, Breast Neoadjuvant

Status:

Open

Randomized Phase III Trial Evaluating the Role of Weight Loss in Adjuvant Treatment of Overweight and Obese Women with Early Breast Cancer   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 … Continue reading ALLIANCE A011401

ALLIANCE A011502

Primary Category:

Cancer Control and Prevention Protocols

Disease Category:

Adjuvant Breast, Breast

Status:

Open

A Randomized Phase III Double-Blinded Placebo Controlled Trial of Aspirin as Adjuvant Therapy for Node Positive HER2 Negative Breast Cancer: The ABC Trial  

ALLIANCE A021202

Primary Category:

Treatment Protocols

Disease Category:

Carcinoid

Status:

Closed

Prospective Randomized Phase II Trial of Pazopanib (NSC # 737754, IND 75648) versus Placebo in Patients with Progressive Carcinoid Tumors   Alliance A021202 has reached its accrual goal. The study was temporarily suspended for case reviews and now will be closed to new patient accrual. Therefore, effective Friday October 7th, 2016 at 5:00 PM EST, … Continue reading ALLIANCE A021202

ALLIANCE A021302

Primary Category:

Radiation Oncology, Treatment Protocols

Disease Category:

Gastrointestinal, Stomach

Status:

Closed

Impact of Early FDG-PET Directed Intervention on Preoperative Therapy for Locally Advanced Gastric Cancer: A Random Assignment Phase II Study   Please see additional protocol credentialing requirements for the surgical component (15.1.1), imaging (6.3), and RT (7.3.2).  All credentialing requirements must be met prior to patient enrollment. A021302 has been unable to meet required monthly accrual … Continue reading ALLIANCE A021302

ALLIANCE A021501

Primary Category:

Radiation Oncology, Treatment Protocols

Disease Category:

Gastrointestinal, Pancreatic

Status:

Open

Preoperative extended chemotherapy vs. chemotherapy plus hypofractionated radiation therapy for borderline resectable adenocarcinoma of the head of the pancreas  

ALLIANCE A031102

Primary Category:

Treatment Protocols

Disease Category:

Genitourinary

Status:

Open

A Randomized Phase III Trial Comparing Conventional-Dose Chemotherapy Using Paclitaxel, Ifosfamide, and Cisplatin (TIP) with High-Dose Chemotherapy Using Mobilizing Paclitaxel Plus Ifosfamide Followed by High-Dose Carboplatin and Etoposide (TI-CE) as First Salvage Treatment in Relapsed or Refractory Germ Cell Tumors

ALLIANCE A031201

Primary Category:

Treatment Protocols

Disease Category:

Genitourinary, Prostate, Prostate Metastatic

Status:

Closed

Phase III Trial of Enzalutamide (NSC #766085) versus Enzalutamide, Abiraterone and Prednisone for Castration Resistant Metastatic Prostate Cancer   A031201 will soon meet its accrual goal. Therefore, effective August 31, 2016 at 4:30 PM ET, A031201 will be permanently closed to new patient accrual.

ALLIANCE A031203

Primary Category:

Treatment Protocols

Disease Category:

Genitourinary, Renal, Renal Metastatic

Status:

Closed

Randomized Phase II Study Comparing Cabozantinib (NSC #761968 and IND #116059) with Commercially Supplied Sunitinib in Patients with Previously Untreated Locally Advanced or Metastatic Renal Cell Carcinoma   Effective Monday, April 6th, 2015 at 4:30 PM (ET), Alliance A031203 permanently closed to new patient accrual.

ALLIANCE A041202

Primary Category:

Treatment Protocols

Disease Category:

Chronic Lymphocytic Leukemia, Leukemia

Status:

Closed

A Randomized Phase III Study Of Bendamustine PLUS Rituximab Versus Ibrutinib Plus Rituximab Versus Ibrutinib  Alone In Untreated Older Patients (≥ 65 Years Of Age) With Chronic Lymphocytic Leukemia (CLL)   A041202 will soon meet its accrual goal. Therefore, EFFECTIVE MONDAY, DECEMBER 28, 2015 at 4:30 pm ET, A041202 will permanently close to new patient … Continue reading ALLIANCE A041202

ALLIANCE A061202

Primary Category:

Treatment Protocols

Disease Category:

Multiple Myeloma

Status:

Temporarily Closed

A Phase I/II Study of Pomalidomide, Dexamethasone and Ixazomib VS. Pomalidomide and Dexamethasone for Patients with Multiple Myeloma Refractory to Lenalidomide and Proteasome Inhibitor-Based Therapy   Effective IMMEDIATELY, Thursday, June 1, 2017, A061202 will be temporarily suspended to new patient accrual pending revised study design.

ALLIANCE A061402

Primary Category:

Cancer Control and Prevention Protocols, Treatment Protocols

Disease Category:

Other

Status:

Open

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

ALLIANCE A071101

Primary Category:

Treatment Protocols

Disease Category:

Brain

Status:

Closed

A Phase II Randomized Trial Comparing the Efficacy of Heat Shock Protein Peptide Complex-96 (HSPPC-96) (NSC #725085, ALLIANCE IND #15380) Vaccine Given with Bevacizumab versus Bevacizumab Alone in the Treatment of Surgically Resectable Recurrent Glioblastoma Multiforme (GBM) Closed effective 02/21/17  

ALLIANCE A071102

Primary Category:

Treatment Protocols

Disease Category:

Brain

Status:

Temporarily Closed

A Phase II/III Randomized Trial Of Veliparib Or Placebo In Combination With Adjuvant Temozolomide In Newly Diagnosed Glioblastoma With MGMT Promoter Hypermethylation   The Phase II portion of A071102 will soon meet its accrual goal. Therefore, EFFECTIVE, Friday, October 21, 2016, at 4:00 PM ET, Alliance A071102 will be temporarily suspended to new patient pre-registration (Step … Continue reading ALLIANCE A071102

ALLIANCE A071401

Primary Category:

Treatment Protocols

Disease Category:

Brain

Status:

Open

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. 

ALLIANCE A071601

Primary Category:

Treatment Protocols

Disease Category:

Brain

Status:

New, Open

Phase II Trial of BRAF/MEK Inhibitors in Papillary Craniopharyngiomas  

ALLIANCE A081105

Primary Category:

Treatment Protocols

Disease Category:

Lung, Lung - Non-Small Cell, Molecular Profiling

Status:

Open

Randomized Double Blind Placebo Controlled Study of Erlotinib or Placebo in Patients with Completely Resected Epidermal Growth Factor Receptor (EGFR) Mutant Non-Small Cell Lung Cancer (NSCLC)   (See required screening study ALLIANCE A151216)

ALLIANCE A091304

Primary Category:

Treatment Protocols

Disease Category:

Sarcoma

Status:

Temporarily Closed

A Phase I/ Randomized Phase II Study of MLN0128 Vs. Pazopanib in Patients with Locally Advanced/Unresectable and/or Metastatic Sarcoma   Effective immediately, slot reservation, pre-registration, and registration to A091304 has been temporarily suspended. As per section 13.7.2, the study status has changed due to an adverse event stopping rule for patients receiving pazopanib. Patients randomized to … Continue reading ALLIANCE A091304

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   (The trial requires additional patients to complete the evaluation of the trial design in the current protocol. Therefore, effective Wednesday, March 16, 2016 at 12PM ET Alliance A091401 is reactivated to pre-registration. Furthermore, both treatment arms will be … Continue reading ALLIANCE A091401

ALLIANCE A091404

Primary Category:

Treatment Protocols

Disease Category:

Head and Neck

Status:

Open

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

ALLIANCE A151216

Primary Category:

Treatment Protocols

Disease Category:

Lung, Lung - Non-Small Cell, Molecular Profiling

Status:

Open

Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial (ALCHEMIST) A screening trial for A081105, E4512, and EA5142.

ALLIANCE A221101

Primary Category:

Cancer Control and Prevention Protocols

Disease Category:

Brain

Status:

Open

A Phase III Randomized, Double-Blind Placebo Controlled Study of Armodafinil (NUVIGIL®) to Reduce Cancer-Related Fatigue in Patients with High Grade Glioma Eligible for screening study DCP 001

ALLIANCE A221102

Primary Category:

Cancer Control and Prevention Protocols

Disease Category:

Breast

Status:

Open

Randomized Double-Blind Placebo Controlled Study of Subcutaneous Testosterone in the Adjuvant Treatment of Postmenopausal Women with Aromatase Inhibitor Induced Arthralgias Eligible for screening study DCP 001

ALLIANCE A221208

Primary Category:

Cancer Control and Prevention Protocols, Radiation Oncology

Disease Category:

Brain Metastatic

Status:

Open

Randomized Phase II Study: Corticosteroids and Bevacizumab vs. Corticosteroids and Placebo (BeSt) for Radionecrosis after Radiosurgery for Brain Metastases   Eligible for screening study DCP 001

ALLIANCE A221304

Primary Category:

Cancer Control and Prevention Protocols, Radiation Oncology

Status:

Closed

A Phase III Placebo-controlled, Randomized Three-arm Study of Doxepin and a Topical Rinse in the Treatment of Acute Oral Mucositis Pain in Patients Receiving Radiotherapy with or without Chemotherapy   A221304 will soon enroll sufficient patients to meet the study accrual goal. Therefore, EFFECTIVE MONDAY, MAY 16, 2016 at 4:30 pm ET, A221304 will permanently close to new patient … Continue reading ALLIANCE A221304

ALLIANCE A221405

Primary Category:

Cancer Control and Prevention Protocols, Treatment Protocols

Disease Category:

Adjuvant Breast, Breast

Status:

Open

Pregnancy Outcome and Safety of Interrupting Therapy for women with endocrine responsIVE breast cancer Eligible for screening study DCP 001

ALLIANCE A221502

Primary Category:

Cancer Control and Prevention Protocols

Disease Category:

Lung

Status:

Open

Pulmonary Rehabilitation before Lung Cancer Resection Limited institution study: open only to Billings Clinic

ALLIANCE C140503

Primary Category:

Surgical Protocols

Disease Category:

Lung, Lung - Non-Small Cell

Status:

Closed

A Phase III Randomized Trial of Lobectomy versus Sublobar Resection for Small (≤ 2 cm) Peripheral Non-Small Cell Lung Cancer   (See Section 9.0 for required surgical credentialing.) 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 … Continue reading ALLIANCE C140503

ALLIANCE C30610

Primary Category:

Radiation Oncology, Treatment Protocols

Disease Category:

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

Status:

Open

Phase III Comparison of Thoracic Radiotherapy Regimens in Patients with Limited Small Cell Lung Cancer Also Receiving Cisplatin and Etoposide 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

Status:

Closed

A Randomized Phase II Trial of Ofatumumab and Bendamustine VS. Ofatumumab, Bortezomib (NSC #681239, IND #58443) and Bendamustine in Patients with Untreated Follicular Lymphoma   (See Section 11.0 for required PET/CT credentialing.) CALGB 50904 has met its accrual goal. Therefore, effective Tuesday, April 5, 2016 at 4:30 PM ET, CALGB 50904 will permanently close to new patient accrual.

ALLIANCE C70807

Primary Category:

Cancer Control and Prevention Protocols

Disease Category:

Genitourinary, Prostate

Status:

Closed

The Men’s Eating and Living (MEAL)Study: A Randomized Trial of Diet to Alter Disease Progression in Prostate Cancer Patients on Active Surveillance   CALGB 70807 has enrolled sufficient patients to the pre-registration step of the study to meet the registration/randomization accrual goal.  Therefore, effective Friday, August 14, 2015 at 5:00 PM ET, CALGB 70807 will be … Continue reading ALLIANCE C70807

ALLIANCE C80702

Primary Category:

Treatment Protocols

Disease Category:

Colon, Gastrointestinal

Status:

Closed

A Phase III Trial of 6 versus 12 Treatments of Adjuvant FOLFOX Plus Celecoxib or Placebo for Patients With Resected Stage III Colon Cancer   CALGB/SWOG 80702 is nearing its accrual goal. Therefore, effective Friday, November 20th, 2015 at 4:30 PM ET, CALGB/SWOG 80702 will permanently close to new patient accrual.

ALLIANCE C80803

Primary Category:

Radiation Oncology, Treatment Protocols

Disease Category:

Esophageal, Gastrointestinal

Status:

Closed

Randomized Phase II Trial of PET Scan-Directed Combined Modality Therapy in Esophageal Cancer   CALGB 80803 has met its accrual goal. Therefore, effective Monday, May 11, 2015 at 4:30 PM (ET), CALGB 80803 will permanently close to new patient accrual.

ALLIANCE C90203

Primary Category:

Treatment Protocols

Disease Category:

Genitourinary, Prostate

Status:

Closed

A Randomized Phase III Study of Neoadjuvant Docetaxel and Androgen Deprivation Prior to Radical Prostatectomy versus Immediate Radical Prostatectomy in Patients with High-Risk, Clinically Localized Prostate Cancer   CALGB 90203 has met its accrual goal. Therefore, effective Friday, October 2nd, 2015 at 4:30 PM EST, CALGB 90203 will permanently close to new patient accrual.

ALLIANCE N0392

Primary Category:

Cancer Control and Prevention Protocols

Status:

Open

Assessment of Patient Satisfaction with Participation in Phase II/III NCCTG Clinical Trials  

ALLIANCE N0577

Primary Category:

Radiation Oncology, Treatment Protocols

Disease Category:

Brain

Status:

Open

Phase III Intergroup Study of Temozolomide Alone versus Radiotherapy with Concomitant and Adjuvant Temozolomide versus Radiotherapy with Adjuvant PCV Chemotherapy in Patients with 1p/19q Co-deleted Anaplastic Glioma

ALLIANCE N1048

Primary Category:

Radiation Oncology, Treatment Protocols

Disease Category:

Gastrointestinal, Rectal

Status:

Open

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)

DCP 001

Primary Category:

Cancer Control and Prevention Protocols

Disease Category:

Other

Status:

Open

Use of a Clinical Trial Screening Tool to Address Cancer Health Disparities in the NCI Community Oncology Research Program (NCORP)  

ECOG-ACRIN E1305

Primary Category:

Treatment Protocols

Disease Category:

Head and Neck, Head and Neck Metastatic

Status:

Closed

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

ECOG-ACRIN E1411

Primary Category:

Treatment Protocols

Disease Category:

Lymphoma, Mantle cell Lymphoma, Non-Hodgkin Lymphoma

Status:

Closed

Intergroup Randomized Phase II Four Arm Study In Patients With Previously Untreated Mantle Cell Lymphoma Of Therapy With: Arm A = Rituximab+ Bendamustine Followed By Rituximab Consolidation (RB → R); Arm B = Rituximab + Bendamustine + Bortezomib Followed By Rituximab Consolidation (RBV→ R), Arm C = Rituximab + Bendamustine Followed By Lenalidomide + Rituximab … Continue reading ECOG-ACRIN E1411

ECOG-ACRIN E1412

Primary Category:

Treatment Protocols

Disease Category:

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

Status:

Closed

Randomized Phase II Open Label Study of Lenalidomide R-CHOP (R2CHOP) vs RCHOP (Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone) in Patients with Newly Diagnosed Diffuse Large B Cell Lymphoma E1412 is successfully approaching its accrual goal, therefore this study will be closed to Step 0 accrual effective January 17, 2017 at 5pm ET.

ECOG-ACRIN E1910

Primary Category:

Treatment Protocols

Disease Category:

Acute Lymphocytic Leukemia, Leukemia

Status:

Open

A Phase III Randomized Trial of Blinatumomab for Newly Diagnosed BCR-ABL-negative B lineage Acute Lymphoblastic Leukemia in Adults

ECOG-ACRIN E1912

Primary Category:

Treatment Protocols

Disease Category:

Chronic Lymphocytic Leukemia, Leukemia

Status:

Closed

A Randomized Phase III Study of Ibrutinib (PCI-32765)-based Therapy vs Standard Fludarabine, Cyclophosphamide, and Rituximab (FCR) Chemoimmunotherapy in Untreated Younger Patients with Chronic Lymphocytic Leukemia (CLL)   E1912 will close to Accrual Effective June 9, 2016 at 5:00 pm ET due to reaching its accrual goal.

ECOG-ACRIN E1A11

Primary Category:

Treatment Protocols

Disease Category:

Multiple Myeloma

Status:

Open

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)   Drug distribution for Carfilzomib is shifting from Fisher Clinical Services to Amgen as of 05/10/17 and Update 3. Institutions should allow … Continue reading ECOG-ACRIN E1A11

ECOG-ACRIN E2108

Primary Category:

Treatment Protocols

Disease Category:

Breast, Breast Metastatic, Breast Neoadjuvant

Status:

Closed

A Randomized Phase III Trial of the Value of Early Local Therapy for the Intact Primary Tumor in Patients with Metastatic Breast Cancer   E2108 is approaching its accrual goal. Therefore, this study closed to accrual effective July 23, 2015 at 5:00 p.m. EDT for Step 1 registrations.  Patients already registered to Step 1 may continue … Continue reading ECOG-ACRIN E2108

ECOG-ACRIN E2112

Primary Category:

Treatment Protocols

Disease Category:

Breast, Breast Metastatic

Status:

Open

A Randomized Phase III Trial of Endocrine Therapy plus Entinostat/Placebo in Patients with Hormone Receptor-Positive Advanced Breast Cancer   As described in Section 9.2 of the protocol, accrual of new patients having non- measurable disease only will stop, as the planned accrual of approximately 20% of the target population has been reached. Patients with non-measurable disease only … Continue reading ECOG-ACRIN E2112

ECOG-ACRIN E2905

Primary Category:

Treatment Protocols

Disease Category:

Leukemia, Myelodysplastic Syndrome

Status:

Closed

Randomized Phase III Trial Comparing the Frequency of Major Erythroid Response (MER) to Treatment with Lenalidomide (Revlimid®) Alone and in Combination with Epoetin Alfa (Procrit®) in Subjects with Low- or Intermediate-1 Risk MDS and Symptomatic Anemia   New accrual to E2905 is closed effective May 13, 2016 due to the study meeting the protocol criteria … Continue reading ECOG-ACRIN E2905

ECOG-ACRIN E2906

Primary Category:

Treatment Protocols

Disease Category:

Acute Myeloid Leukemia, Leukemia

Status:

Closed

Phase III Randomized Trial of Clofarabine as Induction and Post-Remission Therapy vs. Standard Daunorubicin & Cytarabine Induction and Intermediate Dose Cytarabine Post-Remission Therapy, Followed by Decitabine Maintenance vs. Observation in Newly-Diagnosed Acute Myeloid Leukemia in Older Adults (Age ≥ 60 Years)

ECOG-ACRIN E3612

Primary Category:

Treatment Protocols

Disease Category:

Melanoma, Metastatic Melanoma

Status:

Open

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

Status:

Closed

Randomized Phase III Trial of Lenalidomide Versus Observation Alone in Patients with Asymptomatic High-Risk Smoldering Multiple Myeloma   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 E4512

Primary Category:

Treatment Protocols

Disease Category:

Lung, Lung - Non-Small Cell, Molecular Profiling

Status:

Open

A Phase III Double-Blind Trial for Surgically Resected Early Stage Non-Small Cell Lung Cancer: Crizotinib versus Placebo for Patients with Tumors Harboring the Anaplastic Lymphoma Kinase (ALK) Fusion Protein   (See required screening study ALLIANCE A151216)

ECOG-ACRIN E5103

Primary Category:

Treatment Protocols

Disease Category:

Adjuvant Breast, Breast

Status:

Closed

A Double-Blind Phase III Trial of Doxorubicin and Cyclophosphamide followed by Paclitaxel with Bevacizumab or Placebo in Patients with Lymph Node Positive and High Risk Lymph Node Negative Breast Cancer   E5103 Step 3 registration, registration to the EL112LAB substudy, will close to accrual on July 29, 2016.

ECOG-ACRIN E5508

Primary Category:

Treatment Protocols

Disease Category:

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

Status:

Closed

Randomized Phase III Study of Maintenance Therapy with Bevacizumab, Pemetrexed, or a Combination of Bevacizumab and Pemetrexed Following Carboplatin, Paclitaxel and Bevacizumab for Advanced Non-Squamous NSCLC   E5508 is approaching its Step 1 accrual goal. Therefore, this study will close Step 1 accrual effective May 8, 2015 at 5:00 p.m. EST for registrations. Patients registered … Continue reading ECOG-ACRIN E5508

ECOG-ACRIN EA1131

Primary Category:

Treatment Protocols

Disease Category:

Adjuvant Breast, Breast

Status:

Open

A Randomized Phase III Post-Operative Trial of Platinum Based Chemotherapy Vs. Observation in Patients with Residual Triple-Negative Basal-Like Breast Cancer following Neoadjuvant Chemotherapy  

ECOG-ACRIN EA2133

Primary Category:

Treatment Protocols

Disease Category:

Anal, Gastrointestinal

Status:

Open

An International Multicentre Open Label Randomised Phase II Advanced Anal Cancer Trial Comparing Cisplatin plus 5-fluorouracil versus Carboplatin plus Weekly Paclitaxel in Patients with Inoperable Locally Recurrent or Metastatic Disease EA2133 is successfully approaching its accrual goal. Therefore, EA2133 will close to accrual on September 27, 2017 at 5:00pm ET for new patient registration.

ECOG-ACRIN EA2142

Primary Category:

Treatment Protocols

Disease Category:

Gastrointestinal, Neuroendocrine

Status:

Open

Randomized Phase II Study of Cisplatin and Etoposide versus Temozolomide and Capecitabine in Patients with Advanced G3 Non-Small Cell Gastroenteropancreatic Neuroendocrine Carcinomas

ECOG-ACRIN EA2161

Primary Category:

Treatment Protocols

Disease Category:

Carcinoid, Gastrointestinal, Neuroendocrine, Pancreatic

Status:

Open

A Phase II Study of MLN0128 (TAK-228) in Rapalog-Resistant Advanced Pancreatic Neuroendocrine Tumors (PNET)  

ECOG-ACRIN EA3132

Primary Category:

Radiation Oncology, Treatment Protocols

Disease Category:

Head and Neck

Status:

Open

Phase II Randomized Trial of Adjuvant Radiotherapy with or Without Cisplatin for p53 Mutated, Surgically Resected Squamous Cell Carcinoma of the Head and Neck (SCCHN)  

ECOG-ACRIN EA5142

Primary Category:

Treatment Protocols

Disease Category:

Lung, Lung - Non-Small Cell, Molecular Profiling

Status:

Open

Adjuvant Nivolumab in Resected Lung Cancers (ANVIL)-A Randomized Phase III Study of Nivolumab After Surgical Resection and Adjuvant Chemotherapy in Non-Small Cell Lung Cancers   (See required screening study ALLIANCE A151216)  

ECOG-ACRIN EA6134

Primary Category:

Treatment Protocols

Disease Category:

Melanoma, Metastatic Melanoma

Status:

Open

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

ECOG-ACRIN EA6141

Primary Category:

Treatment Protocols

Disease Category:

Melanoma, Metastatic Melanoma

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 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 … Continue reading ECOG-ACRIN EA6141

ECOG-ACRIN EA8141

Primary Category:

Surgical Protocols, Treatment Protocols

Disease Category:

Genitourinary, Renal

Status:

Open

A Prospective Phase II Trial of Neoadjuvant Systemic Chemotherapy Followed by Extirpative Surgery for Patients with High Grade Upper Tract Urothelial Carcinoma Arm A of EA8141 will be closed to accrual effective May 31, 2017 at 5PM EST as it will have met its accrual goal.

ECOG-ACRIN EA8143

Primary Category:

Treatment Protocols

Disease Category:

Genitourinary, Renal

Status:

Open

A Phase 3 RandOmized Study Comparing PERioperative Nivolumab vs. Observation in Patients with Localized Renal Cell Carcinoma Undergoing Nephrectomy (PROSPER RCC)

ECOG-ACRIN EAQ152

Primary Category:

Cancer Control and Prevention Protocols

Disease Category:

Brain, Breast, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Lung, Lymphoma, Melanoma, Molecular Profiling, Other, Sarcoma

Status:

Closed

COMET – Communication and Education in Tumor Profiling: A Randomized Study of Pre-disclosure Genetic Education v. Usual Care in Tumor Profiling for Advanced Cancer and a Pilot Study of Remote Genetic Counseling for Participants with Potential Germline Mutations Identified on Tumor Profiling (Sub-study for EAY131) Eligible for screening study DCP 001 MCC not eligible to participate … Continue reading ECOG-ACRIN EAQ152

ECOG-ACRIN EAY131

Primary Category:

Treatment Protocols

Disease Category:

Brain, Breast, Carcinoid, Gastrointestinal, Genitourinary, Gynecologic, Head and Neck, Lung, Lymphoma, Melanoma, Molecular Profiling, Other, Sarcoma

Status:

Open

Molecular Analysis for Therapy Choice (MATCH)   (Available sub-study for additional online genetic counseling, ECOG-ACRIN EAQ152) As of Addendum #10, activated on May 11, 2017, 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 … Continue reading ECOG-ACRIN EAY131

ECOG-ACRIN EAY131-A

Primary Category:

Treatment Protocols

Disease Category:

Molecular Profiling

Status:

Open

MATCH Treatment Subprotocol A: Phase II Trial of Afatinib in Patients with Solid Tumors (Other Than Small Cell and Non-Small Cell Lung Cancer) or Lymphomas, That Have Activating Mutations of EGFR and Have Progressed After Standard Treatment   (See required screening study ECOG-ACRIN EAY131) Open  to participants with results from one of the designated outside … Continue reading ECOG-ACRIN EAY131-A

ECOG-ACRIN EAY131-B

Primary Category:

Treatment Protocols

Disease Category:

Molecular Profiling

Status:

Open

MATCH Treatment Subprotocol B: Phase II Study of Afatinib in Patients with Tumors with HER2 Activating Mutations   (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 406-237-5467, for the consent … Continue reading ECOG-ACRIN EAY131-B

ECOG-ACRIN EAY131-C1

Primary Category:

Treatment Protocols

Disease Category:

Molecular Profiling

Status:

Open

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 … Continue reading ECOG-ACRIN EAY131-C1

ECOG-ACRIN EAY131-C2

Primary Category:

Treatment Protocols

Disease Category:

Molecular Profiling

Status:

Open

MATCH Treatment Subprotocol C2: Crizotinib in Patients with Tumors with MET Exon 14 Deletion   (See required screening study ECOG-ACRIN EAY131) Open  to participants with results from one of the designated outside laboratories indicating a “rare variant that is an actionable Mutation of Interest (aMOI) for specific designated rare variant subprotocols. See Appendix XIV of … Continue reading ECOG-ACRIN EAY131-C2

ECOG-ACRIN EAY131-E

Primary Category:

Treatment Protocols

Disease Category:

Molecular Profiling

Status:

Open

MATCH Treatment Subprotocol E: AZD9291 in Patients with Tumors Having EGFR T790M Mutations (Except Non-Small Cell Lung Cancer) or Rare Activating Mutations of EGFR   (See required screening study ECOG-ACRIN EAY131) Open  to participants with results from one of the designated outside laboratories indicating a “rare variant that is an actionable Mutation of Interest (aMOI) … Continue reading ECOG-ACRIN EAY131-E

ECOG-ACRIN EAY131-F

Primary Category:

Treatment Protocols

Disease Category:

Molecular Profiling

Status:

Open

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 … Continue reading ECOG-ACRIN EAY131-F

ECOG-ACRIN EAY131-G

Primary Category:

Treatment Protocols

Disease Category:

Molecular Profiling

Status:

Open

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 … Continue reading ECOG-ACRIN EAY131-G

ECOG-ACRIN EAY131-H

Primary Category:

Treatment Protocols

Disease Category:

Molecular Profiling

Status:

Open

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) Open  to participants with results from one of the designated outside laboratories indicating a “rare variant that is an actionable Mutation of … Continue reading ECOG-ACRIN EAY131-H

ECOG-ACRIN EAY131-I

Primary Category:

Treatment Protocols

Disease Category:

Molecular Profiling

Status:

Closed

MATCH Treatment Subprotocol I: EAY131-I: GDC-0032 (taselisib) in Patients with Tumors (other than breast cancer) with PIK3CA mutation but without KRAS mutation or PTEN loss   (See required screening study ECOG-ACRIN EAY131) 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, … Continue reading ECOG-ACRIN EAY131-I

ECOG-ACRIN EAY131-J

Primary Category:

Treatment Protocols

Disease Category:

Molecular Profiling

Status:

Open

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 406-237-5467, for the consent & … Continue reading ECOG-ACRIN EAY131-J

ECOG-ACRIN EAY131-L

Primary Category:

Treatment Protocols

Disease Category:

Molecular Profiling

Status:

Open

MATCH Treatment Subprotocol L: Phase II Study of MLN0128 (TAK-228) in Patients with Tumors with mTOR Mutations (See required screening study ECOG-ACRIN EAY131) Open  to participants with results from one of the designated outside laboratories indicating a “rare variant that is an actionable Mutation of Interest (aMOI) for specific designated rare variant subprotocols. See Appendix … Continue reading ECOG-ACRIN EAY131-L

ECOG-ACRIN EAY131-M

Primary Category:

Treatment Protocols

Disease Category:

Molecular Profiling

Status:

Open

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. … Continue reading ECOG-ACRIN EAY131-M

ECOG-ACRIN EAY131-N

Primary Category:

Treatment Protocols

Disease Category:

Molecular Profiling

Status:

Temporarily Closed

MATCH Treatment Subprotocol N: EAY131-N: Phase II Study of PI3K Beta Specific Inhibitor, GSK2636771, in Patients with Tumors with PTEN Mutation or Deletion, with PTEN Expression on IHC   (See required screening study ECOG-ACRIN EAY131) All new treatment assignments to EAY131 (MATCH) Subprotocol N, EAY131-N, are suspended effective immediately today, 11/16/16, due to acute shortage in the … Continue reading ECOG-ACRIN EAY131-N

ECOG-ACRIN EAY131-P

Primary Category:

Treatment Protocols

Disease Category:

Molecular Profiling

Status:

Closed

MATCH Treatment Subprotocol P: EAY131-P: Phase II Study of PI3K Beta Specific Inhibitor, GSK2636771, in Patients with Tumors with PTEN Loss by IHC (See required screening study ECOG-ACRIN EAY131) 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 406-237-5467, … Continue reading ECOG-ACRIN EAY131-P

ECOG-ACRIN EAY131-Q

Primary Category:

Treatment Protocols

Disease Category:

Molecular Profiling

Status:

Closed

MATCH Treatment Subprotocol Q: Ado-trastuzumab Emtansine in Patients with Tumors with HER2 Amplification (Except Breast and Gastric/Gastro-Esophageal Junction (GEJ) Adenocarcinomas)   (See required screening study ECOG-ACRIN EAY131) 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 406-237-5467, … Continue reading ECOG-ACRIN EAY131-Q

ECOG-ACRIN EAY131-R

Primary Category:

Treatment Protocols

Disease Category:

Molecular Profiling

Status:

Temporarily Closed

MATCH Treatment Subprotocol R: Phase II Study of Trametinib in Patients with BRAF Fusions, or with Non-V600E, Non-V600K BRAF Mutations   (See required screening study ECOG-ACRIN EAY131) 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 … Continue reading ECOG-ACRIN EAY131-R

ECOG-ACRIN EAY131-S1

Primary Category:

Treatment Protocols

Disease Category:

Molecular Profiling

Status:

Temporarily Closed

MATCH Treatment Subprotocol S1: EAY131-S1: Phase II Study of Trametinib in Patients with Tumors with NF1 mutations   (See required screening study ECOG-ACRIN EAY131) 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 406-237-5467, for the consent & … Continue reading ECOG-ACRIN EAY131-S1

ECOG-ACRIN EAY131-S2

Primary Category:

Treatment Protocols

Disease Category:

Molecular Profiling

Status:

Open

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. … Continue reading ECOG-ACRIN EAY131-S2

ECOG-ACRIN EAY131-T

Primary Category:

Treatment Protocols

Disease Category:

Molecular Profiling

Status:

Open

MATCH Treatment Subprotocol T: GDC-0449 (vismodegib) in Patients with Tumors (except basal cell skin carcinoma) with Smoothened (SMO) or Patched 1 (PTCH1) Mutations   (See required screening study ECOG-ACRIN EAY131) Open  to participants with results from one of the designated outside laboratories indicating a “rare variant that is an actionable Mutation of Interest (aMOI) for specific designated … Continue reading ECOG-ACRIN EAY131-T

ECOG-ACRIN EAY131-U

Primary Category:

Treatment Protocols

Disease Category:

Molecular Profiling

Status:

Open

MATCH Treatment Subprotocol U: VS-6063 (defactinib) in Patients with Tumors with NF2 Loss   (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 … Continue reading ECOG-ACRIN EAY131-U

ECOG-ACRIN EAY131-V

Primary Category:

Treatment Protocols

Disease Category:

Molecular Profiling

Status:

Open

MATCH Treatment Subprotocol V: Phase II Study of Sunitinib in Patients with Tumors with cKIT Mutations (Excluding GIST, Renal Cell Carcinoma or Pancreatic Neuroendocrine Tumor)   (See required screening study ECOG-ACRIN EAY131) Open  to participants with results from one of the designated outside laboratories indicating a “rare variant that is an actionable Mutation of Interest … Continue reading ECOG-ACRIN EAY131-V

ECOG-ACRIN EAY131-W

Primary Category:

Treatment Protocols

Disease Category:

Molecular Profiling

Status:

Open

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) 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 406-237-5467, for … Continue reading ECOG-ACRIN EAY131-W

ECOG-ACRIN EAY131-X

Primary Category:

Treatment Protocols

Disease Category:

Molecular Profiling

Status:

Open

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) 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 … Continue reading ECOG-ACRIN EAY131-X

ECOG-ACRIN EAY131-Y

Primary Category:

Treatment Protocols

Disease Category:

Molecular Profiling

Status:

Temporarily Closed

MATCH Treatment Subprotocol Y: AZD5363 in Patients with Tumors with AKT 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 … Continue reading ECOG-ACRIN EAY131-Y

ECOG-ACRIN EAY131-Z1A

Primary Category:

Treatment Protocols

Disease Category:

Molecular Profiling

Status:

Temporarily Closed

MATCH Treatment Subprotocol Z1A: Binimetinib in Patients with Tumors (Other Than Melanoma) with NRAS Mutations   (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 406-237-5467, for the consent & for … Continue reading ECOG-ACRIN EAY131-Z1A

ECOG-ACRIN EAY131-Z1B

Primary Category:

Treatment Protocols

Disease Category:

Molecular Profiling

Status:

Open

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) Open  to participants with results from one of the designated outside laboratories indicating a “rare variant that is an actionable Mutation of Interest … Continue reading ECOG-ACRIN EAY131-Z1B

ECOG-ACRIN EAY131-Z1C

Primary Category:

Treatment Protocols

Disease Category:

Molecular Profiling

Status:

Open

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) Open  to participants with results from one of the designated outside laboratories indicating a “rare variant that is an actionable Mutation of Interest (aMOI) … Continue reading ECOG-ACRIN EAY131-Z1C

ECOG-ACRIN EAY131-Z1D

Primary Category:

Treatment Protocols

Disease Category:

Molecular Profiling

Status:

Temporarily Closed

MATCH Treatment Subprotocol Z1D: Nivolumab in Patients with Tumors with Mismatch Repair Deficiency (Excluding Colorectal Cancer)   (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 406-237-5467, for the consent & … Continue reading ECOG-ACRIN EAY131-Z1D

ECOG-ACRIN EAY131-Z1E

Primary Category:

Treatment Protocols

Disease Category:

Molecular Profiling

Status:

Open

MATCH Treatment Subprotocol Z1E: LOXO-101 in Patients with Tumors with NTRK Fusions (See required screening study ECOG-ACRIN EAY131) Open  to participants with results from one of the designated outside laboratories indicating a “rare variant that is an actionable Mutation of Interest (aMOI) for specific designated rare variant subprotocols. See Appendix XIV of the main protocol … Continue reading ECOG-ACRIN EAY131-Z1E

ECOG-ACRIN EAY131-Z1I

Primary Category:

Treatment Protocols

Disease Category:

Molecular Profiling

Status:

Open

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) 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 406-237-5467, for the consent … Continue reading ECOG-ACRIN EAY131-Z1I

ECOG-ACRIN NHLBI-MDS

Primary Category:

Cancer Control and Prevention Protocols

Disease Category:

Leukemia, Myelodysplastic Syndrome

Status:

Open

The National Myelodysplastic Syndromes (MDS) Study   Eligible for screening study DCP 001

ECOG-ACRIN PACCT-1

Primary Category:

Treatment Protocols

Disease Category:

Adjuvant Breast, Breast

Status:

Closed

Program for the Assessment of Clinical Cancer Tests (PACCT-1): Trial Assigning Individualized Options for Treatment: The TAILORx Trial   Ancillary study EL112LAB for the PACCT1 Trial has reached its accrual goal. Therefore, PACCT1 Step 3 registration (EL112LAB) will be closed to accrual effective Friday, July 3, 2015 at 5:00 pm EST.  (E5103 accrual remains open … Continue reading ECOG-ACRIN PACCT-1

GOG Foundation GOG-3015 / Y039523

Primary Category:

Treatment Protocols

Disease Category:

Gynecologic, Ovarian, Ovarian Metastatic

Status:

New, Open

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 Limited institution study: open only to Billings Clinic

NCI 9671

Primary Category:

Cancer Control and Prevention Protocols

Disease Category:

Molecular Profiling, Other

Status:

Closed

Exceptional Responders Pilot study: Molecular profiling of tumors from cancer patients who are exceptional responders   All cases must be provisionally approved by NCI, before enrollment.  Once a case is approved by NCI, then the IRB approval process takes place.  Due to the completion of accrual, new case proposal assignments to this protocol will be … Continue reading NCI 9671

NRG B-51

Primary Category:

Radiation Oncology, Treatment Protocols

Disease Category:

Breast, Breast Neoadjuvant

Status:

Open

Randomized Phase III Clinical Trial Evaluating Post-Mastectomy Chestwall and Regional Nodal XRT and Post-Lumpectomy Regional Nodal XRT in Patients with Positive Axillary Nodes Before Neoadjuvant Chemotherapy Who Convert to Pathologically Negative Axillary Nodes After Neoadjuvant Chemotherapy

NRG B-52

Primary Category:

Treatment Protocols

Disease Category:

Breast, Breast Neoadjuvant

Status:

Closed

A Randomized Phase III Trial Evaluating Pathologic Complete Response Rates in Patients with Hormone Receptor-Positive, HER2-Positive, Large Operable and Locally Advanced Breast Cancer Treated with Neoadjuvant Therapy of Docetaxel, Carboplatin, Trastuzumab, and Pertuzumab (TCHP) With or Without Estrogen Deprivation   B-52 will close to accrual, today, February 29, 2016, effective 8 pm EST. We realize that … Continue reading NRG B-52

NRG B-55

Primary Category:

Treatment Protocols

Disease Category:

Adjuvant Breast, Breast, Breast Neoadjuvant

Status:

Open

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  

NRG BN001

Primary Category:

Radiation Oncology, Treatment Protocols

Disease Category:

Brain

Status:

Closed

Randomized Phase II Trial of Hypofractionated Dose-Escalated Photon IMRT or Proton Beam Therapy versus Conventional Photon Irradiation with Concomitant and Adjuvant Temozolomide in Patients with Newly Diagnosed Glioblastoma The photon cohort of BN001 is closed to accrual at 5 PM EST Tuesday, December 20, because it has reached its accrual target.

NRG BN003

Primary Category:

Radiation Oncology, Treatment Protocols

Disease Category:

Brain

Status:

New, Open

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

NRG BR002

Primary Category:

Radiation Oncology, Treatment Protocols

Disease Category:

Breast, Breast Metastatic

Status:

Open

A Phase IIR/III Trial of Standard of Care Therapy with or without Stereotactic Body Radiotherapy (SBRT) and/or Surgical Ablation for Newly Oligometastatic Breast Cancer

NRG BR003

Primary Category:

Treatment Protocols

Disease Category:

Adjuvant Breast, Breast

Status:

Open

A Randomized Phase III Trial of Adjuvant Therapy Comparing Doxorubicin Plus Cyclophosphamide Followed by Weekly Paclitaxel with or without Carboplatin for Node Positive or High-Risk Node-Negative Triple-Negative Invasive Breast Cancer

NRG BR005

Primary Category:

Treatment Protocols

Disease Category:

Breast, Breast Neoadjuvant

Status:

New, Open

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

NRG CC001

Primary Category:

Radiation Oncology, Treatment Protocols

Disease Category:

Brain

Status:

Open

A Randomized Phase III Trial of Memantine and Whole-Brain Radiotherapy With or Without Hippocampal Avoidance in Patients With Brain Metastases Eligible for screening study DCP 001  

NRG CC002

Primary Category:

Cancer Control and Prevention Protocols

Disease Category:

Gynecologic

Status:

Closed

Pre-Operative Assessment and Post-Operative Outcomes of Elderly Women with Gynecologic Cancers   NRG CC002 is rapidly approaching its accrual goal (100 eligible patients undergoing primary cytoreduction). As a result, it is planned to close to accrual on Monday, November 2, 2015.  

NRG CC003

Primary Category:

Radiation Oncology

Disease Category:

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

Status:

Open

Randomized Phase II/III Trial of Prophylatic Cranial Irradiation With or Without Hippocampal Avoidance for Small Cell Lung Cancer Eligible for screening study DCP 001

NRG CC004

Primary Category:

Cancer Control and Prevention Protocols

Disease Category:

Breast, Gynecologic

Status:

New, Open

Phase II Double Blind Dose Finding Trial of Bupropion Versus Placebo for Sexual Desire in Women with Breast or Gynecologic Cancer

NRG G0225

Primary Category:

Cancer Control and Prevention Protocols

Disease Category:

Gynecologic

Status:

Open

Can Diet and Physical Activity Modulate Ovarian, Fallopian Tube and Primary Peritoneal Cancer Progression-Free Survival? Eligible for screening study DCP 001

NRG G0237

Primary Category:

Cancer Control and Prevention Protocols

Disease Category:

Other

Status:

Open

Comparative Analysis of CA-IX, p16, Proliferative Markers, and Human Papilloma Virus (HPV) in the Diagnosis of Significant Cervical Lesions in Patients with a Cytologic Diagnosis of Atypical Glandular Cells (AGC) Eligible for screening study DCP 001  

NRG G0238

Primary Category:

Radiation Oncology, Treatment Protocols

Disease Category:

Endometrial, Gynecologic

Status:

Open

A Randomized Trial of Pelvic Irradiation with or Without Concurrent Weekly Cisplatin in Patients with Pelvic-Only Recurrence of Carcinoma of the Uterine Corpus

NRG G0263

Primary Category:

Radiation Oncology, Treatment Protocols

Disease Category:

Cervical, Gynecologic

Status:

Open

Randomized Phase III Clinical Trial of Adjuvant Radiation Versus Chemoradiation in Intermediate Risk, Stage I/IIA Cervical Cancer Treated with Initial Radical Hysterectomy and Pelvic Lymphadenectomy  

NRG G0264

Primary Category:

Treatment Protocols

Disease Category:

Gynecologic, Ovarian

Status:

Open

A Randomized Phase II Trial of Paclitaxel and Carboplatin  Vs. Bleomycin, Etoposide, and Cisplatin For Newly Diagnosed Advanced Stage and Recurrent Chemonaive Sex Cord-Stromal Tumors of the Ovary

NRG G0270

Primary Category:

Radiation Oncology, Surgical Protocols, Treatment Protocols

Disease Category:

Gynecologic

Status:

Closed

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

NRG G0274

Primary Category:

Radiation Oncology, Treatment Protocols

Disease Category:

Cervical, Gynecologic

Status:

Closed

A Phase III Trial of Adjuvant Chemotherapy Following Chemoradiation as Primary Treatment for Locally Advanced Cervical Cancer Compared to Chemoradiation Alone:  The Outback Trial 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 … Continue reading NRG G0274

NRG G0281

Primary Category:

Treatment Protocols

Disease Category:

Gynecologic, Ovarian

Status:

Closed

A Randomized Phase II/III Study to Assess the Efficacy of Trametinib (GSK 1120212) in Patients with Recurrent or Progressive Low-Grade Serous Ovarian Cancer or Peritoneal Cancer   G0281 has met its target accrual goal in the U.S. and the study is no longer accepting any additional specimens for screening.  Closure notice to follow soon.  

NRG G0286B

Primary Category:

Treatment Protocols

Disease Category:

Endometrial, Endometrial Metastatic, Gynecologic

Status:

Open

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 The phase II portion of G0286B was reviewed and approved to progress to the phase III portion of the study. It will reopen effective December 5, 2016.

NRG GI002

Primary Category:

Radiation Oncology, Treatment Protocols

Disease Category:

Gastrointestinal, Rectal

Status:

Open

A Phase II Clinical Trial Platform of Sensitization Utilizing Total Neoadjuvant Therapy (TNT) in Rectal Cancer  

NRG GU001

Primary Category:

Radiation Oncology

Disease Category:

Bladder, Genitourinary

Status:

Closed

Randomized Phase II Trial of Postoperative Adjuvant IMRT Following  Cystectomy for pT3/pT4 Urothelial Bladder Cancer

NRG GU002

Primary Category:

Radiation Oncology, Treatment Protocols

Disease Category:

Genitourinary, Prostate

Status:

New, Open

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

NRG GU003

Primary Category:

Radiation Oncology, Treatment Protocols

Disease Category:

Genitourinary, Prostate

Status:

New, Open

A Randomized Phase III Trial of Hypofractionated Post-Prostatectomy Radiation Therapy (HYPORT) versus Conventional Post-Prostatectomy Radiation Therapy (COPORT)  

NRG GY003

Primary Category:

Treatment Protocols

Disease Category:

Gynecologic, Ovarian

Status:

Closed

Phase II Randomized Trial of Nivolumab with or without Ipilimumab in Patients with Persistent or Recurrent Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancer   NRG-GY003 has met its first stage accrual goal and is temporarily closed to patient entry effective October 7, 2015. A decision about re-opening this study will be made when analysis … Continue reading NRG GY003

NRG GY004

Primary Category:

Treatment Protocols

Disease Category:

Gynecologic, Ovarian

Status:

Open

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

NRG GY005

Primary Category:

Treatment Protocols

Disease Category:

Gynecologic, Ovarian

Status:

Temporarily Closed

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) NRG-GY005: Will temporarily closed to accrual at 5:00 PM ET on June 16, 2017.

NRG GY006

Primary Category:

Radiation Oncology, Treatment Protocols

Disease Category:

Cervical, Gynecologic

Status:

Open

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

NRG GY008

Primary Category:

Treatment Protocols

Disease Category:

Endometrial, Gynecologic

Status:

Temporarily Closed

A Phase II Evaluation of Copanlisib (BAY 80-6946) (IND#130822), A Selective Inhibitor of PI3KCA, in Patients with Persistent or Recurrent Endometrial Carcinoma Harboring PIK3CA Hotspot Mutations Effective immediately, no additional patients will be accepted for PIK3CA mutation screening for NRG-GY008. The stage 1 target accrual is close to being met.

NRG GY011

Primary Category:

Surgical Protocols

Disease Category:

Endometrial, Gynecologic

Status:

New, Open

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  

NRG HN002

Primary Category:

Radiation Oncology, Treatment Protocols

Disease Category:

Head and Neck

Status:

Closed

A Randomized Phase II Trial for Patients with p16 Positive, Non-Smoking Associated, Locoregionally Advanced Oropharyngeal Cancer Closed effective 02/07/17.  Accrual goal met.

NRG LU001

Primary Category:

Radiation Oncology, Treatment Protocols

Disease Category:

Lung, Lung - Non-Small Cell

Status:

Closed

Randomized Phase II Trial of Concurrent Chemoradiotherapy +/- Metformin HCL in Locally Advanced NSCLC LU001 is closed effective December 15, 2016 because it has reached its accrual target.

NRG LU002

Primary Category:

Radiation Oncology, Treatment Protocols

Disease Category:

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

Status:

Open

Maintenance Systemic Therapy Versus Consolidative Stereotactic Body Radiation Therapy (SBRT) Plus Maintenance Systemic Therapy for Limited Metastatic Non-Small Cell Lung Cancer (NSCLC): A Randomized Phase II/III Trial  

NRG R0534

Primary Category:

Radiation Oncology, Treatment Protocols

Disease Category:

Genitourinary, Prostate, Prostate Recurrent

Status:

Closed

A Phase III Trial of Short Term Androgen Deprivation with Pelvic Lymph Node or Prostate Bed Only Radiotherapy (SPPORT) in Prostate Cancer Patients with a Rising PSA After Radical Prostatectomy 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 R0631

Primary Category:

Radiation Oncology, Treatment Protocols

Disease Category:

Other

Status:

Closed

Phase II/III Study of Image-Guided Radiosurgery/SBRT for Localized Spine Metastasis Eligible for screening study DCP 001 R0631 will close to accrual at 5 PM EST on Friday, August 4, 2017, because the phase III component has reached its accrual target.

NRG R0724

Primary Category:

Radiation Oncology, Treatment Protocols

Disease Category:

Cervical, Gynecologic

Status:

Open

Phase III Randomized Study of Concurrent Chemotherapy and Pelvic Radiation Therapy with or without Adjuvant Chemotherapy in High-Risk Patients with Early-Stage Cervical Carcinoma Following Radical Hysterectomy  

NRG R0815

Primary Category:

Radiation Oncology, Treatment Protocols

Disease Category:

Genitourinary, Prostate

Status:

Closed

A Phase III Prospective Randomized Trial of Dose-Escalated Radiotherapy with or without Short-Term Androgen Deprivation Therapy for Patients with Intermediate-Risk Prostate Cancer   R0815 will close to accrual at 5 PM EST on Monday, March 7, 2016, because the study has reached its accrual target.

NRG R0848

Primary Category:

Radiation Oncology, Treatment Protocols

Disease Category:

Gastrointestinal, Pancreatic

Status:

Open

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

NRG R0912

Primary Category:

Radiation Oncology, Treatment Protocols

Disease Category:

Thyroid

Status:

Closed

A Randomized Phase II Study of Concurrent Intensity Modulated Radiation Therapy (IMRT), Paclitaxel and Pazopanib (NSC 737754)/Placebo, for the Treatment of Anaplastic Thyroid Cancer R0912 is closed to accrual effective December 30, 2016 because it has reached its accrual target.  

NRG R0920

Primary Category:

Radiation Oncology, Treatment Protocols

Disease Category:

Head and Neck

Status:

Open

A Phase III Study of Postoperative Radiation Therapy (IMRT) +/- Cetuximab for Locally-Advanced Resected Head and Neck Cancer

NRG R0924

Primary Category:

Radiation Oncology, Treatment Protocols

Disease Category:

Genitourinary, Prostate

Status:

Open

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.)

NRG R1008

Primary Category:

Radiation Oncology, Treatment Protocols

Disease Category:

Head and Neck

Status:

Open

A Randomized Phase II/Phase III Study of Adjuvant Concurrent Radiation and Chemotherapy Versus Radiation Alone in Resected High-Risk Malignant Salivary Gland Tumors  

NRG R1010

Primary Category:

Radiation Oncology, Treatment Protocols

Disease Category:

Esophageal, Gastrointestinal

Status:

Closed

A Phase III Trial Evaluating the Addition of Trastuzumab to Trimodality Treatment of HER2-Overexpressing Esophageal Adenocarcinoma   R1010 will close to STEP 1 registration at 5 PM EST on Tuesday, November 10, 2015, because the study has reached its accrual target.  STEP 2 registration will remain open and all eligible patients determined to be HER2 positive will … Continue reading NRG R1010

NRG R1201

Primary Category:

Radiation Oncology, Treatment Protocols

Disease Category:

Gastrointestinal, Pancreatic

Status:

Closed

A Phase II Randomized Trial Evaluating the Addition of High or Standard Intensity Radiation to Gemcitabine and Nab-Paclitaxel for Locally Advanced Pancreatic Cancer   R1201 is permanently closed to accrual, effective immediately, June 30, 2016. After an accrual assessment by CTEP it was determined that the trial would not be completed within a reasonable timeframe per … Continue reading NRG R1201

NRG R1203

Primary Category:

Radiation Oncology, Treatment Protocols

Disease Category:

Cervical, Endometrial, Gynecologic

Status:

Closed

A Randomized Phase III Study of Standard vs. IMRT Pelvic Radiation for Post-Operative Treatment of Endometrial and Cervical Cancer (TIME-C)   NRG 1203 closed to accrual at 5 PM EST Thursday, August 27, 2015 because it had reached its accrual target.

NRG R1205

Primary Category:

Radiation Oncology, Treatment Protocols

Disease Category:

Brain

Status:

Closed

Randomized Phase II Trial of Concurrent Bevacizumab and Re-Irradiation Versus Bevacizumab Alone As Treatment for Recurrent Glioblastoma   R1205 will close to accrual at 5 PM EST Thursday, April 28th, 2016, because it has reached its accrual target.

NRG R1306

Primary Category:

Radiation Oncology, Treatment Protocols

Disease Category:

Lung, Lung - Non-Small Cell

Status:

Temporarily Closed

A Randomized Phase II Study of Individualized Combined Modality Therapy for Stage III Non-Small Cell Lung Cancer (NSCLC) Accrual of new patients must be suspended until the IRB of record has approved Amendment 8. To be reviewed at the September 8, 2017 IRB Meeting.

SWOG 8811 (S1206)

Primary Category:

Radiation Oncology, Treatment Protocols

Disease Category:

Lung, Lung - Non-Small Cell

Status:

New, Open

A Dose Finding Study Followed by Phase II Randomized, Placebo-Controlled Study of Veliparib (ABT-888) Added to Chemoradiotherapy with Carboplatin and Paclitaxel for Unresectable Stage III Non-Small Cell Lung Cancer (NSCLC)

SWOG S0819

Primary Category:

Treatment Protocols

Disease Category:

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

Status:

Closed

A Randomized, Phase III Study Comparing Carboplatin/Paclitaxel or Carboplatin/Paclitaxel/Bevacizumab with or without Concurrent Cetuximab in Patients with Advanced Non-Small Cell Lung Cancer (NSCLC)   Protocol permanently closed to accrual on May 1st, 2015 due to DSMB recommendations.

SWOG S0820

Primary Category:

Cancer Control and Prevention Protocols

Disease Category:

Colon, Gastrointestinal

Status:

Open

A Double Blind Placebo-Controlled Trial of Eflornithine and Sulindac to Prevent Recurrence of High Risk Adenomas and Second Primary Colorectal Cancers in Patients with Stage 0-III Colon Cancer, Phase III- Preventing Adenomas of the Colon with Eflornithine and Sulindac (PACES) Eligible for screening study DCP 001

SWOG S0919

Primary Category:

Treatment Protocols

Disease Category:

Acute Myeloid Leukemia, Leukemia

Status:

Closed

A Phase II Study of Idarubicin and Ara-C in Combination with Pravastatin for Poor-Risk Acute Myelogenous Leukemia (AML) S0919 will be permanently closed to accrual effective September 15, 2017 at 11:59 p.m. Pacific.

SWOG S0931

Primary Category:

Treatment Protocols

Disease Category:

Genitourinary, Renal

Status:

Closed

EVEREST: EVErolimus for Renal Cancer Ensuing Surgical Therapy, A Phase III Study   S0931 has met its accrual goal and will permanently close to accrual effective September 15, 2016 at 11:59 p.m. Pacific Time.

SWOG S1001

Primary Category:

Treatment Protocols

Disease Category:

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

Status:

Closed

A Phase II Trial of PET-Directed Therapy for Limited Stage Diffuse Large B-Cell Lymphoma (DLBCL)   S1001 will be permanently closed to accrual for Step 1 Registration effective June 1, 2016 at 11:59 p.m. PST.

SWOG S1007

Primary Category:

Treatment Protocols

Disease Category:

Adjuvant Breast, Breast

Status:

Closed

A Phase III, Randomized Clinical Trial of Standard Adjuvant Endocrine Therapy +/- Chemotherapy in Patients with 1-3 Positive Nodes, Hormone Receptor-Positive and HER2-Negative Breast Cancer with Recurrence Score (RS) of 25 or Less. RxPONDER: A Clinical Trial Rx for Positive Node, Endocrine Responsive Breast Cancer   S1007 will be permanently closed to accrual for Step 1 … Continue reading SWOG S1007

SWOG S1201

Primary Category:

Treatment Protocols

Disease Category:

Esophageal, Esophageal Metastatic, Gastrointestinal, Stomach, Stomach Metastatic

Status:

Closed

A Randomized Phase II Pilot Study Prospectively Evaluating Treatment for Patients Based on ERCC1(Excision Repair Cross-Complementing 1) for Advanced/Metastatic Esophageal, Gastric or Gastroesophageal Junction (GEJ) Cancer

SWOG S1203

Primary Category:

Treatment Protocols

Disease Category:

Acute Myeloid Leukemia, Leukemia

Status:

Closed

A Randomized Phase III Study of Standard Cytarabine Plus Daunorubicin (7+3) Therapy or Idarubicin with High Dose Cytarabine (IA) Versus IA with Vorinostat (NSC-701852) (IA+V) in Younger Patients with Previously Untreated Acute Myeloid Leukemia (AML)   S1203 is fast-approaching its accrual goal and will permanently close to accrual effective November 4, 2015 at 11:59 pm Pacific Time.

SWOG S1204

Primary Category:

Cancer Control and Prevention Protocols

Disease Category:

Cancer Care Delivery

Status:

Closed

A Sero-Epidemiologic Survey and Cost-Effectiveness Study of Screening for Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV) Among Newly Diagnosed Cancer Patients   (Open only to Billings Clinic) Closed effective 02/15/17.  Accrual goal met.

SWOG S1207

Primary Category:

Treatment Protocols

Disease Category:

Adjuvant Breast, Breast

Status:

Open

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

SWOG S1216

Primary Category:

Treatment Protocols

Disease Category:

Genitourinary, Prostate, Prostate Metastatic

Status:

Closed

A Phase III Randomized Trial Comparing Androgen Deprivation Therapy + TAK-700 with Androgen Deprivation Therapy + Bicalutamide in Patients with Newly Diagnosed Metastatic Hormone Sensitive Prostate Cancer S1216 has met its accrual goal and will permanently close to accrual effective July 15, 2017 at 11:59 p.m. Pacific.

SWOG S1222

Primary Category:

Treatment Protocols

Disease Category:

Breast, Breast Metastatic

Status:

Closed

Fulvestrant Alone Versus Fulvestrant and Everolimus Versus Fulvestrant, Everolimus and Anastrozole:  A Phase III Randomized Placebo-Controlled Trial in Postmenopausal Patients with Hormone-Receptor Positive Stage IV Breast Cancer   S1222 will be permanently closed effective October 15, 2015 due to poor accrual.

SWOG S1304

Primary Category:

Treatment Protocols

Disease Category:

Multiple Myeloma

Status:

Closed

A Phase II Randomized Study Comparing Two Doses of Carfilzomib (NSC-756640) with Dexamethasone for Multiple Myeloma Patients with Relapsed or Refractory Disease   S1304 was temporarily closed to accrual on November 6, 2015. It was anticipated that the study would be re-opened to accrual (subsequent to an accrual target increase due to a higher than anticipated ineligibility rate). … Continue reading SWOG S1304

SWOG S1314

Primary Category:

Treatment Protocols

Disease Category:

Bladder, Genitourinary

Status:

Open

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

SWOG S1320

Primary Category:

Treatment Protocols

Disease Category:

Melanoma

Status:

Open

A Randomized Phase II Trial of Intermittent Versus Continuous Dosing of Dabrafenib (NSC-763760) and Trametinib (NSC-763093) in BRAF V600E/K Mutant Melanoma

SWOG S1400

Primary Category:

Treatment Protocols

Disease Category:

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

Status:

Open

A Biomarker-Driven Master Protocol for Previously Treated Squamous Cell Lung Cancer   Please see new required training for S1400, Revision #3 Training, training must be completed at each site prior to registering any new patients.  The training is posted on the S1400 main study page on the SWOG website as well.

SWOG S1400A

Primary Category:

Treatment Protocols

Disease Category:

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

Status:

Closed

A Phase II Study of MEDI4736 for Previously Treated Patients with Stage IV Squamous Cell Lung Cancer and No Matching Biomarkers (Lung-MAP Sub-Study)   (See required screening study SWOG S1400)   Permanent Closure of S1400A, Arm 2-Docetaxel due to FDA approval of nivolumab. Permanent closure of sub-study due to a revised trial design.

SWOG S1400B

Primary Category:

Treatment Protocols

Disease Category:

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

Status:

Closed

A Phase II Study of GDC-0032 (Taselisib) for Previously Treated PI3K Positive Patients with Stage IV Squamous Cell Lung Cancer (Lung-MAP Sub-Study) (See required screening study SWOG S1400) S1400B is closed to accrual effective December 12, 2016, as the study did not meet teh criterion for the interim futility analysis.

SWOG S1400C

Primary Category:

Treatment Protocols

Disease Category:

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

Status:

Closed

A Phase II Study of Palbociclib for Previously Treated Cell Cycle Gene Alteration Positive Patients with Stage IV Squamous Cell Lung Cancer (Lung-MAP Sub-Study)   (See required screening study SWOG S1400)   Permanent closure of Arm 2 ONLY due to a revised trial design. S1400C will be permanently closed to accrual, effective September 1, 2016, as … Continue reading SWOG S1400C

SWOG S1400D

Primary Category:

Treatment Protocols

Disease Category:

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

Status:

Closed

A Phase II Study of AZD4547 for Previously Treated FGFR-Positive Patients with Stage IV Squamous Cell Lung Cancer (Lung-MAP Sub-Study)   (See required screening study SWOG S1400)   Effective 11:59 p.m. Pacific Time on October 31, 2016, the following sub-study will be permanently closed to accrual, as the study did not meet the criterion for … Continue reading SWOG S1400D

SWOG S1400E

Primary Category:

Treatment Protocols

Disease Category:

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

Status:

Closed

A Phase II/III Randomized Study of Rilotumumab Plus Erlotinib Versus Erlotinib as Second Line Therapy for C-MET Positive Patients with Stage IV Squamous Cell Lung Cancer (Lung-Map Sub-Study)   (See required screening study SWOG S1400)

SWOG S1400G

Primary Category:

Treatment Protocols

Disease Category:

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

Status:

Open

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)

SWOG S1400I

Primary Category:

Treatment Protocols

Disease Category:

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

Status:

Open

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)   (See required screening study SWOG S1400)

SWOG S1403

Primary Category:

Treatment Protocols

Disease Category:

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

Status:

Open

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)

SWOG S1404

Primary Category:

Treatment Protocols

Disease Category:

Melanoma

Status:

Closed

A Phase III Randomized Trial Comparing Physician/Patient Choice of High Dose Interferon or Ipilimumab to MK-3475 (Pembrolizumab) in Patients with High Risk Resected Melanoma 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.

SWOG S1415CD

Primary Category:

Cancer Control and Prevention Protocols

Disease Category:

Cancer Care Delivery

Status:

Open

A Pragmatic Trial Evaluating a Colony Stimulating Factor Intervention in Standing Orders and the Effectiveness of Colony Stimulating Factor Use as Prophylaxis for Patients Receiving Chemotherapy with Intermediate Risk for Febrile Neutropenia   Limited site participation.  Open only to Billings Clinic and Bozeman Health Eligible for screening study DCP 001

SWOG S1416

Primary Category:

Treatment Protocols

Disease Category:

Breast, Breast Metastatic

Status:

Open

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  

SWOG S1417CD

Primary Category:

Cancer Control and Prevention Protocols

Disease Category:

Cancer Care Delivery

Status:

Open

Implementation of a Prospective Financial Impact Assessment Tool in Patients with Metastatic Colorectal Cancer   Eligible for screening study DCP 001

SWOG S1500

Primary Category:

Treatment Protocols

Disease Category:

Renal, Renal Metastatic

Status:

Open

A Randomized, Phase II Efficacy Assessment of Multiple MET Kinase Inhibitors (Cabozantinib [NSC #761968], Crizotinib [NSC #749005], Savolitinib [NSC #785348], and Sunitinib [NSC #736511]) in Metastatic Papillary Renal Carcinoma (PAPMET)  

SWOG S1505

Primary Category:

Treatment Protocols

Disease Category:

Gastrointestinal, Pancreatic

Status:

Open

A Randomized Phase II Study of Perioperative mFOLFIRINOX versus Gemcitabine/nab-Paclitaxel as Therapy for Resectable Pancreatic Adenocarcinoma

SWOG S1507

Primary Category:

Treatment Protocols

Disease Category:

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

Status:

Open

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  

SWOG S1512

Primary Category:

Treatment Protocols

Disease Category:

Melanoma

Status:

Open

A Phase II and Pilot Trial of PD-1 Blockade with MK-3475 (Pembrolizumab) in Patients with Resectable or Unresectable Desmoplastic Melanoma (DM)  

SWOG S1513

Primary Category:

Treatment Protocols

Disease Category:

Gastrointestinal, Pancreatic, Pancreatic Metastatic

Status:

Open

Randomized Phase II Study of 2nd Line FOLFIRI versus Modified FOLFIRI with PARP Inhibitor ABT-888 (Veliparib) (NSC-737664) in Metastatic Pancreatic Cancer  

SWOG S1602

Primary Category:

Treatment Protocols

Disease Category:

Bladder, Genitourinary

Status:

Open

A Phase III Randomized Trial to Evaluate the Influence of BCG Strain Differences and T Cell Priming with Intradermal BCG Before Intravesical Therapy for BCG-Naïve High-Grade Non-Muscle Invasive Bladder Cancer

SWOG S1605

Primary Category:

Treatment Protocols

Disease Category:

Bladder, Genitourinary

Status:

Open

Phase II Trial of Atezolizumab in BCG-Unresponsive Non-Muscle Invasive Bladder Cancer  

SWOG S1608

Primary Category:

Treatment Protocols

Disease Category:

Follicular Lymphoma, Lymphoma, Non-Hodgkin Lymphoma

Status:

New, Open

Randomized Phase II Trial in Early Relapsing or Refractory Follicular Lymphoma  

SWOG S1609

Primary Category:

Treatment Protocols

Disease Category:

Molecular Profiling

Status:

Temporarily Closed

DART: Dual Anti-CTLA-4 and Anti-PD-1 Blockade in Rare Tumors Temporary Closure of Cohort 32, Effective 6/26/17, 5:00pm PT (Cohort 32: Tumor of unknown primary (Cancer of Unknown Primary; CuP)) Temporary Closure of Cohort 23, Effective 6/22/17, 5:00pm PT (Cohort 23: Neuroendocrine carcinoma including carcinoid of the lung) Temporary Closure of Cohort 9, Effective 6/15/17, 5:00pm … Continue reading SWOG S1609

SWOG S1616

Primary Category:

Treatment Protocols

Disease Category:

Melanoma, Metastatic Melanoma

Status:

New, Open

A Phase II Randomized Study of Nivolumab (NSC-748726) with Ipilimumab (NSC-732442) OR Ipilimumab Alone in Advanced Melanoma Patients Refractory to an Anti-PD-1 or Anti PD-L1 Agent

TEST ACCORDION

Primary Category:

Cancer Control and Prevention Protocols

Disease Category:

Brain

Status:

Open

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