Case Comprehensive Cancer Center NCTN Lead Academic Participating Site

PROJECT SUMMARY This project represents the comprehensive efforts of the oncology community at Case Western Reserve University School of Medicine and its three major teaching affiliate hospitals (University Hospitals, Cleveland Clinic, and MetroHealth) to participate as a Lead Academic Participating Site in the National Clinical Trials Network (NCTN). The NCTN, funded and directed by the National Cancer Institute (NCI), is the major consortium for performing federally-funded, national multicenter clinical trials that aim to improve outcomes for cancer patients. The emphasis of NCTN trials is late phase (phase III and relatively large Phase II) trials that address scientific questions that usually cannot be answered by other means such as a single-institution study or an industry company study. The results of these trials often set the standards of care for cancer treatment in the U.S. and the world. This includes clinical trials research in rare cancers and underrepresented populations. Our specific aims for this project are 1) to participate in NCTN trials with exceptionally high levels of accrual volume and quality of data generation and submission for approximately 240 new patients per year; 2) to serve the NCTN and the cancer community by providing scientific and administrative leadership in the (Cooperative) Groups that design and operate these NCTN clinical trials in the entire broad portfolio of cancers; in particular we are full members with many investigator leaders within NRG Oncology, ECOG-ACRIN and SWOG; and 3) to perform and present hypothesis-based, investigator-led research that benefits future NCTN research. This includes secondary clinical and biorepository translational analyses from NCTN data and pilot studies from our institution. We achieve these aims by assembling an outstanding core of investigators representing all the major cancer specialties (surgical, radiation, medical and diagnostic oncology) and disease sites (hematologic, lung, breast, gastrointestinal, genitourinary, brain, gynecologic and melanoma). We have also developed a robust infrastructure of clinical trials operations in support of the NCTN, including the centralized facilities at Case Western and the hospital-based clinical trials units. They ensure timely activation of, and education about, NCTN trials, accrual enhancement, regulatory management and a high quality of research procedures and data submission. Finally, a major priority is the recruitment, development and mentoring of new Case Western investigators' involvement within the NCTN, including their participation in the Groups' activities such as their semi-annual meetings and committee assignments.