Funded Studies

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Approved BIQSFP-Funded Studies Associated with NCI clinical trials (10/31/16):

Type of Study Integral/ Integrated NCTN*/NCORP Protocol ID Phase Protocol Title
Biomarker Integral Alliance
A011106
 (ACOSOG Z11103)
II-III Alternate Approaches for Clinical Stage II & III Estrogen Receptor+Breast Cancer Neoadjuvant Treatment (ALTernate) Study
Biomarker Integrated

Alliance
A011401

III Randomized Phase III Trial Evaluating the Role of Weight Loss In Adjuvant Treatment of Overweight and Obese Women with Early Breast Cancer
Imaging Integral Alliance
A021302
II Impact of Early FDG-PET Directed Intervention on Preoperative Therapy for Locally Advanced Gastric Cancer: A Random Assignment Phase II Study
Imaging Integrated Alliance
A031201
III Phase III Trial of MDV3100 vs. MDV3100 and Abiraterone and Prednisone for Castration Resistant Metastatic Prostate Cancer
Biomarker Integral Alliance
A041501
III A Phase III Trial to Evaluate the Efficacy of the Addition of Inotuzumab Ozogamicin to Frontline Therapy in Young Adults (Ages 16-39 years) with Newly Diagnosed Precursor B-Cell ALL
Biomarker Integral Alliance
A051301
III A Randomized Phase III Study of Ibrutinib During and Following Autologous Stem Cell Transplantation versus Placebo in Patients with Relapsed or Refractory Diffuse Large-Cell Lymphoma of the Activated-B-Cell Subtype
Biomarker Integral Alliance
A071102
II-III Randomized Trial of ABT-888 or Placebo in Combination with Adjuvant Temozolomide in Newly Diagnosed GBM with MGMT Promoter Hypermethylation
Biomarker Integral Alliance
A151216
II-III Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial (ALCHEMIST)
Biomarker Integral & Integrated Alliance
CALGB 30801
III A Randomized Phase III Double Blind Trial Evaluating Selective COX-2 Inhibition in COX-2 Expressing Advanced Non-Small Cell Lung Cancer
Biomarker + Imaging Integral Alliance
CALGB 80803
II A Randomized, Phase 2 Trial of PET Scan-Directed Combined Modality Therapy in Esophageal Cancer
Biomarker Integral Alliance
NCCTG N0577
III Phase III Intergroup Study of Radiotherapy versus Temozolomide Alone versus Radiotherapy with Concomitant and Adjuvant Temozolomide for Patients with 1p/19q Codeleted Anaplastic Glioma
Biomarker Integrated NRG
GOG0186
II A Randomized Phase II Study of NCI Supplied Cabozantinib (NSC #761968 IND #116059) Versus Weekly Paclitaxel (NSC #673089) in the Treatment of Persistent or Recurrent Epithelial Ovarian,
Fallopian Tube or Primary Peritoneal Cancer
Biomarker Integrated ECOG-ACRIN
E1512
II A Randomized Phase II Trial of Erlotinib, Cabozantinib, or Erlotinib plus Cabozantinib as 2nd or 3rd Line Therapy in Patients with EGFR Wild-Type NSCLC
Biomarker Integrated Alliance
A091201
II Randomized Phase II Study Comparing the MET Inhibitor Cabozantinib to Temozolomide/Dacarbazine in Ocular Melanoma
Biomarker Integrated Alliance
A031203
II 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
Biomarker Integral COG
AALL08B1/
AALL1131
Treatment of Newly Diagnosed High-Risk B-precursor Acute Lymphoblastic Leukemia (MRD Bridge Funding)
QOL Integrated COG
 AALL0932
QOL Longitudinal assessment of vincristine-associated peripheral neuropathy
QOL-Imaging Integrated COG
AALL1131
QOL Incidence & Natural History of Osteonecrosis (ON)   
(PARENT STUDY: Treatment of Newly Diagnosed High-Risk B-precursor Acute Lymphoblastic Leukemia)
Biomarker Integral COG
AALL1231
III A Phase 3 Randomized Trial Investigating Bortezomib (PS-341, Velcade) on a Modified Augmented BFM (ABFM) Backbone in Newly Diagnosed T-cell Acute Lymphoblastic Leukemia (T-ALL) and T-cell Lymphoblastic Lymphoma (T-LL)
Biomarker Integral & Integrated COG
AALL1331
III Risk-Stratified Randomized Phase III Testing of Blinatumomab (IND# 100135, NSC# 765986) in First Relapse of Childhood B-Lymphoblastic Leukemia (B-ALL)
Biomarker Integral COG
AALL1631
III International Phase III Trial in Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ ALL) Testing Imatinib in Combination with Two Different Cytotoxic Chemotherapy Backbones
Biomarker Integral & Integrated COG
AAML0531
III A Phase III Randomized Trial of Gemtuzumab Ozogamicin Mylotarg® Combined with Conventional Chemotherapy for De Novo Acute Myeloid Leukemia (AML) in Children, Adolescents, and Young Adults
Biomarker Integral & Integrated COG
AAML1031
III A Phase III Randomized Trial for Patients with de novo AML Using Bortezomib and Lestaurtinib for Patients with FLT3 ITD
Biomarker Integral COG
AAML1531
III Risk-Stratified Therapy for Acute Myeloid Leukemia in Down Syndrome
QOL-Biomarker Integrated COG
ACCL0933
QOL Prospective Evaluation of Galactomannan and (1→3)-β-D-glucan Assays as Diagnostic Tools for Invasive Fungal Infection in Children with Acute Myeloid Leukemia Receiving Fungal Prophylaxis
QOL-Biomarker Integrated COG
ACCL0934

QOL

Prospective Surveillance of Resistance in Colonizing Bacteria from Stool or Perirectal Swab Cultures and in Bacterial Isolates from Sterile Site Cultures in Pediatric Patients Receiving Levofloxacin for Acute Leukemia
Biomarker Integral COG
ACNS1422
II A Phase II Study of Reduced Therapy for Newly Diagnosed Average-Risk WNT-Driven Medulloblastoma Patients
Imaging Integral COG
AHOD1331
III A Randomized Phase III Study of Brentuximab vedotin (Bv, IND #117117) for Newly Diagnosed High Risk Classical Hodgkin Lymphoma (cHL) in Children and Adolescents
Biomarker Integral COG
ANBL1232
III Utilizing Response-and Biology-Based Factors to Guide Therapy in Patients with Non-High-Risk Neuroblastoma
Biomarker Integral COG
ANBL1531
III A Phase III Study of 131IMetaiodobenzylguanidine (131I-MIBG) or Crizotinib Added to Standard Therapy for Children with Newly Diagnosed High-Risk Neuroblastoma (NBL)
Biomarker Integrated COG
ARST13431
III A Randomized Phase III Study of Vincristine, Dactinomycin, Cyclophosphamide (VAC) Alternating with Vincristine and Irinotecan (VI) Versus VAC/VI Plus Temsirolimus (TEM) in Patients with Intermediate Risk (IR) Rhabdomyosarcoma (RMS)
Biomarker Integral COG
ASCT1221
II Randomized Phase II Study Comparing Two Different Conditioning Regimens Prior to Allogeneic Hematopoietic Cell Transplantation (HCT) for Children with Juvenile Myelomonocytic Leukemia (JMML)
Biomarker Integral & Integrated ECOG
E1910
III A Phase III Randomized Trial of Blinatumomab for Newly Diagnosed bcr-abl Negative B Acute Lymphoblastic Leukemia in Adults
Biomarker Integral ECOG-ACRIN
EA1131
III A Randomized Phase III Post-Operative Trial of Platinum Based Chemotherapy Vs. Observation in Patients with Residual Triple-Negative Breast Cancer Following Neoadjuvant Chemotherapy
Biomarker Integrated ECOG-ACRIN
EA1412
II Randomized Phase II Open Label Study of RCHOP with and without Lenalidomide in Newly Diagnosed Diffuse Large B Cell Lymphoma (DLBCL)
Biomarker Integral ECOG-ACRIN
EA2132
II Randomized Phase I/II Study Of mFOLFOX6 +/- AMG 337 in the First Line Treatment of Patients with Her2Neu Negative and High c-Met Expressing Advanced Esophagogastric and Gastroesophageal Junction (GEJ) Adenocarcinoma
Biomarker Integral ECOG-ACRIN
EA3132
II 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)
Biomarker Integral & Integrated ECOG-ACRIN
EA4151
III 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
QOL Integrated GOG
UC0604
(GOG 0249)
III A Phase III Trial of Pelvic Radiation Therapy vs. Vaginal Cuff Brachytherapy Followed by Paclitaxel/Carboplatin Chemotherapy in Patients with High Risk Early Stage Endometrial Carcinoma
Biomarker Integral NRG
NRG-BN001
(RTOG 1326)
II Randomized Phase II Trial of Hypofractionated Dose-Escalated Particle Beam Therapy Versus Conventional Photon Irradiation with Concomitant and Adjuvant Temozolomide in Patients with Newly Diagnosed GBM
CEA Integrated NRG
NRG-CC003
II-III Randomized Phase II/III Trial of Prophylactic Cranial Irradiation with or without Hippocampal Avoidance (HA) for Small Cell Lung Cancer (SCLC)
Biomarker Integral

NRG
NRG-HN001
(RTOG 1305)  

II-III Randomized Phase II and Phase III Studies of Individualized Treatment for Nasopharyngeal Carcinoma Based on Biomarker Epstein Barr Virus (EBV) Deoxyribonucleic Acid (DNA)
Imaging Integrated NRG
NRG-HN002
(RTOG 1221)
II A Randomized Phase II Trial of Reduced-Dose IMRT with Weekly Cisplatin versus Mildly Accelerated Reduced-Dose IMRT Alone for p16 Positive, Non-Smoking Associated Oropharyngeal Cancer
QOL Integrated NRG
NSABP-MA32.F
III Biobehavioral Mechanisms of Fatigue in Patients Treated on MA 32: A Phase III Randomized Trial of the Effect of Metformin versus Placebo on Recurrence and Survival in Early Stage Breast Cancer (A Phase III Clinical Trial Comparing Adjuvant Sunitinib Malate to Placebo in Women with Residual Invasive Breast Cancer Following Neoadjuvant Chemotherapy)
Imaging Integrated NRG
RTOG 0825/
ACRIN 6686
III Phase III Double-Blind Placebo-Controlled Trial of Conventional Concurrent Chemoradiation and Adjuvant Temozolomide Plus Bevacizumab Versus Conventional Concurrent Chemoradiation and Adjuvant Temozolomide in Patients with Newly Diagnosed Glioblastoma
Biomarker Integral NRG
RTOG 1010
III A Phase III Trial Evaluating the Addition of Trastuzumab to Trimodality Treatment of HER2 Overexpressing Esophageal Adenocarcinoma
Biomarker Integral NRG
RTOG 1016
II-III Phase II-III Trial of Moderate De-Escalation of Chemotherapy and Radiation in Favorable Risk, Locally Advanced, HPV-Associated Oropharynx Cancer
Biomarker Integral NRG
RTOG 1201
II A SMAD4-driven Phase II Randomized Trial of High Versus Standard Intensity Local or Systemic Therapy for Unresectable Pancreatic Cancer
Biomarker Integral NRG
RTOG 1216
II-III Randomized Phase II/III Trial of Surgery and Postoperative Radiation Delivered with Concurrent Cisplatin Versus Docetaxel Versus Cetuximab and Docetaxel for High-Risk Squamous Cell Cancer of the Head and Neck
Biomarker Integral & Integrated SWOG
S0819
III A Randomized , Phase 3 Study Comparing Carboplatin/ Paclitaxel/ Bevacizumab with or without Concurrent Cetuximab in Patients with Advanced Non-Small Cell Lung Cancer (NSCLC)
Biomarker Integral SWOG
S1007
III A Phase III, Randomized Clinical Trial of Standard Adjuvant, Endocrine Therapy +/- Chemotherapy in Patients with 1-3 Positive Nodes, Hormone-responsive and HER2-negative Breast Cancer According to Recurrence Score (RS)
Biomarker Integral SWOG
S1201
II A Randomized Phase II Pilot Study Prospectively Assigning Treatment for Patients Based on ERCC1 for Advanced/Metastatic Gastric Cancer or Gastroesophageal (GE) Junction Cancer
Biomarker Integrated SWOG
S1300
II A Randomized, Phase II Trial of Crizotinib Plus Pemetrexed Versus Pemetrexed Monotherapy in ALK-Positive Non-Squamous NSCLC Patients who have Progressed Systemically after Previous Clinical Benefit from Crizotinib Monotherapy
Biomarker Integral & Integrated SWOG
S1314
II A Randomized Phase II Study of CO-eXpression ExtrapolatioN (COXEN)-Directed Neoadjuvant Chemotherapy for Localized, Muscle-Invasive Bladder Cancer
Biomarker Integral & Integrated SWOG
S1416
II Randomized Phase II Trial of Cisplatin +/- Veliparib in Metastatic TNBC and gBRCAm
Biomarker Integrated SWOG
S1500
II A Biomarker Analysis of MET Alterations and Papillary Subtype in S1500: A Randomized, Phase II trial of MET Inhibitors in Metastatic Papillary Kidney Cancer
Biomarker Integrated SWOG
S1513
II Randomized Phase II Study of 2nd Line Therapy with FOLFIRI with or without PARP Inhibitor Veliparib (ABT-888) in Metastatic Pancreatic Cancer
Biomarker Integrated SWOG
S1602
III A Randomized Trial to Evaluate (1) the Influence of BCG Strain Differences, and (2) T-cell Priming with Intradermal BCG Before Intravesical Therapy—for BCG-Naïve High-Grade Non-Muscle Invasive Bladder Cancer
Imaging Integral SWOG
S1608
II Randomized Phase II Trial in High-Risk Relapsed Refractory Follicular Lymphoma
Biomarker Integral SWOG
S1612
II-III A Randomized Phase II/III Trial of “Novel Therapeutic(s)” Versus Azacitidine in Newly Diagnosed Patients with Acute Myeloid Leukemia Age 60 or Older
Biomarker Integral SWOG
S1613
II Randomized Phase II study of Pertuzumab and Trastuzumab compared to Cetuximab and Irinotecan in Advanced/ Metastatic Colorectal Cancer (mCRC) with HER2 Amplification

* Formerly Cooperative Groups/CCOPs

updated 10/31/2016