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July 2014

NRG Oncology CPAC Report J. Tate Thigpen, MD NRG Oncology Deputy Group Chair Concept Prioritization& Conduct. July 2014. CPAC Composition Group Chairs (3) Group Deputy Chairs (6) Statistical Leaders (3) Functions RSC Approved Study Prioritization Oversight of A ctive Trials

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July 2014

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  1. NRG Oncology CPAC ReportJ. Tate Thigpen, MDNRG Oncology Deputy Group Chair Concept Prioritization& Conduct July 2014

  2. CPAC • Composition • Group Chairs (3) • Group Deputy Chairs (6) • Statistical Leaders (3) • Functions • RSC Approved Study Prioritization • Oversight of Active Trials • Oversight of Analysis, Publication Process

  3. Breast Cancer: NSABP B-55 BIG 6-13 [OlmpiA] 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. Active 7/3/2014 Principal Investigators Charles Geyer, Jr., MD, Judy Garber, MD

  4. Breast Cancer: NRG BR001 A Phase 1 Study of Stereotactic Body Radiotherapy (SBRT) for the Treatment of Multiple Metastases Pre-Activation 6/30/2014 Principal InvestigatorSteven Chmura, MD

  5. Head & Neck Cancer: NRG HN001 Randomized Phase II and Phase III Studies of Individualized Treatment for Nasopharyngeal Carcinoma Based on Biomarker Epstein Barr Virus (EBV) Deoxyribonucleic Acid (DNA). Active 4/21/2014PI Principal Investigator Nancy Lee, MD.

  6. Sarcoma: ARST1321 PazopanibNeoadjuvant Trial in Non-Rhabdomyosarcoma Soft Tissue Sarcomas (PAZNTIS): A Phase II/III Randomized Trial of Preoperative Chemoradiation or Preoperative Radiation Plus or Minus Pazopanib (NSC# 737754, IND# 118613) Pre-Activated 7/7/2014 Principal Investigators Aaron Weiss, DO (COG) Yen-Lin Chen, MD (NRG)

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