This application supports the participation of the University of the Chicago Comprehensive Cancer Center (UCCCC) as a Lead Academic Participating Site in the National Clinical Trials Network (NCTN). The NCTN develops and performs state-of-the-art early and late stage clinical trials for the treatment of adults with cancer. UCCCC is a long-standing member of the Alliance for Clinical Trials in Oncology, the Radiation Therapy Oncology Group, and the Gynecologic Oncology Group. The UCCCC will provide multi-disciplinary scientific and administrative leadership in the design of innovative and potentially practice-changing clinical trials within the NCTN. UCCCC faculty members will contribute to the NCTN as operational leaders, committee chairs, committee vice-chairs, committee leaders, and study chairs, and as members of NCI Advisory and Scientific Committees. Preliminary studies performed by UCCCC investigators at the University of Chicago through the U0l Phase 1 Cooperative Agreement and the N0I Phase 1 Clinical Trials Contract will be brought to the NCTN for large scale testing. Laboratories at the University of Chicago will perform correlative studies that will support NCTN trials. University of Chicago senior faculty will mentor young investigators to become future leaders in the NCTN. The UCCCC has the infrastructure for the initiation and conduct of a wide spectrum of clinical trials, supported through the Cancer Clinical Trials Office (CCTO), a formal Core Facility of the Cancer Center Support Grant, which manages the regulatory activities for all adult cancer-related clinical trials. The NCTN Lead Academic Participating Site Program activities at UCCCC will be coordinated by a Steering Committee of 4 Principal Investigators who represent medical, surgical, radiation, and gynecologic oncology, and 2 senior administrative leaders in the UCCCC. The Steering Committee will oversee the NCTN Coordinating Center in the Cancer Clinical Trials Office, which will provide centralized regulatory oversight and data quality contro support for the implementation, quality execution of, and efficient accrual to, NCTN trials across the Network. UCCCC will collaborate with the Network Group Operations Centers and the associated Network Group Statistics and Data Management Centers to achieve the research goals of the NCTN program. The UCCCC will thus provide a mechanism for robust accrual to trials across the NCTN, with participation across all tumor types, including trials for rare cancer and in a diverse patient population, at UCCCC and 9 /Affiliate institutions.
NCTN trials set the standards for cancer treatment in the United States and across the world. The significant recent advances in the basic sciences cannot benefit patients unless new treatments are proven safe and beneficial in the clinical setting, UCCCC will contribute to the goals of the NCTN by providing the scientific leadership to develop trials that have a significant impact on treatment and the infrastructure to effectively accrue to clinical trials across the NCTN.