Funded Studies

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Approved BIQSFP-Funded Studies Associated with NCI clinical trials (12/29/15):

Type of StudyFY ApprovedIntegral/ IntegratedNCTN Group/ NCORP* Study NumberPhaseConcept TitleCancer Site
Biomarker 2015 Integral SWOG S1416 II Randomized Phase II Trial of Cisplatin +/- Veliparib in Metastatic TNBC and gBRCAm Breast
Cost-Effectiveness Analysis (CEA) 2015 (n/a) 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) Lung
Biomarker 2015 Integral COG AAML1531 III Risk-Stratified Therapy for Acute Myeloid Leukemia in Down Syndrome Leukemia
Biomarker 2015 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 Lymphoma
Imaging 2014 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 Gastric
Biomarker 2014 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 Breast
Biomarker 2014 Integral COG AALL0931/ AALL1131 III Treatment of Newly Diagnosed High-Risk B-precursor Acute Lymphoblastic Leukemia (MRD Bridge Funding) Pediatric Leukemia
Imaging 2014 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 Lymphoma
Biomarker 2014 Integral 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 Glioblastoma
Biomarker 2014 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 Glioblastoma
Biomarker 2014 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) Lymphoma/ Leukemia
Biomarker 2013 Integrated ECOG 1412 II Randomized Phase II Open Label Study of RCHOP with and without Lenalidomide in Newly Diagnosed Diffuse Large B Cell Lymphoma   (DLBCL) Lymphoma
Biomarker 2013 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) Pediatric Leukemia
Biomarker 2013 Integral Alliance A151216 II-III Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial (ALCHEMIST) Lung
Biomarker 2013 Integral & Integrated SWOG 1314 II A Randomized Phase II Study of CO-eXpression ExtrapolatioN (COXEN)-Directed Neoadjuvant Chemotherapy for Localized, Muscle-Invasive Bladder Cancer Bladder
Biomarker 2013 Integral 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)
Biomarker 2013 Integrated COG ANBL1232 III Utilizing Response-and Biology-Based Factors to Guide Therapy in Patients with Non-High-Risk Neuroblastoma Pediatric Neuroblastoma
Biomarker 2013 Integrated SWOG 1300 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 Lung
Imaging 2013 Integrated RTOG 1221 (NRG-HN002) 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 Oropharynx
Biomarker 2013 Integrated CABOZANTINIB STUDIES (GOG0186 + E1512 + A091201 + A031203) II Measurement of MET/IHC Across Patients with Ovarian, RCC, NSCLC, and Ocular Melanoma Cancers Ovarian, RCC, Lung, OM
Biomarker 2013 Integrated RTOG 1201 II A SMAD4-driven Phase II Randomized Trial of High Versus Standard Intensity Local or Systemic Therapy for Unresectable Pancreatic Cancer Pancreas
Biomarker 2012 Integral & Integrated ECOG 1910 III A Phase III Randomized Trial of Blinatumomab for Newly Diagnosed bcr-abl Negative B Acute Lymphoblastic Leukemia in Adults ALL
Imaging 2012 Integrated Alliance A031201 III Phase III Trial of MDV3100 vs. MDV3100 and Abiraterone and Prednisone for Castration Resistant Metastatic Prostate Cancer Prostate
Biomarker 2012 Integral 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 Head & Neck
Biomarker 2012 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) Pediatric JMML
Biomarker 2012 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 Gastric/GE junction
Biomarker 2011 Integral Alliance A011106 (ACOSOG Z11103) II-III Alternate Approaches for Clinical Stage II & III Estrogen Receptor + Breast Cancer Neoadjuvant Treatment (ALTernate) Study Breast
Biomarker + Imaging 2011 Integral CALGB 80803 II A Randomized, Phase 2 Trial of PET Scan-Directed Combined Modality Therapy in Esophageal Cancer Esophageal
Biomarker 2011 Integral 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 Oropharynx
Biomarker 2011 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 Pediatric ACL
Biomarker 2011 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 Pediatric ACL
Imaging 2011 Integrated COG AALL 1131 QOL Incidence & Natural History of Osteonecrosis (ON) + Longitudinal, Computerized Assessment of Neurocognitive Functioning in Children with High-Risk Acute Lymphoblastic Leukemia (PARENT STUDY: Treatment of Newly Diagnosed High-Risk B-precursor Acute Lymphoblastic Leukemia) Pediatric ALL
Biomarker 2010 Integral & Integrated SWOG 0819 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) Lung
Biomarker 2010 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) Breast
QOL 2010 Integrated COG AALL 0932 QOL Longitudinal assessment of vincristine-associated peripheral neuropathy Pediatric ALL
Biomarker 2010 Integral & Integrated COG AAML 1031 III A Phase III Randomized Trial for Patients with de novo AML using Bortezomib and Lestaurtinib for patients with FLT3 ITD Pediatric AML
Imaging 2010 Integrated 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 Glioblastoma
Biomarker 2010 Integral RTOG 1010 III A Phase III Trial Evaluating the Addition of Trastuzumab to Trimodality Treatment of HER2 Overexpressing Esophageal Adenocarcinoma Esophageal
Biomarker 2010 Integral 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 Glioma
Biomarker 2009 Integral & Integrated 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 Lung
Biomarker 2008 Integral 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 Pediatric AML
QOL 2010 Integrated NSABP MA-32F 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) Breast
QOL 2008 Integrated GOG UC0604

(GOG 0249)

III A Phase III Trial of Pelvic Radiation Therapy vs. Vaginal Cuff Brachytherapy Followed by Paclitaxed/Carboplatin Chemotherapy in Patients with High Risk Early Stage Endometrial Carcinoma Uterine

*Formerly Cooperative Groups/CCOPs