Approved BIQSFP-Funded Studies Associated with NCI clinical trials (03/01/2017):
| 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 | 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 | 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 |
| Imaging | Integrated | NRG-GI002 | II | A Phase II Clinical Trial Platform of Sensitization Utilizing Total Neoadjuvant Therapy (TNT) in Rectal 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