This project is to support the Case Comprehensive Cancer Center (Case CCC) of Case Western Reserve University (CWRU) as a Lead Academic Participating Site in the newly reorganized National Clinical Trials Network (NCTN). The NCTN is a national consortium of Cooperative Groups, Academic and Community institutions, and National Core Facilities working with the NCI to perform practice-changing clinical trials in oncology. This is primarily in the form of Phase 1 and III prospective multicenter trials, and the correlative scientific work associated with these trials. Our role is to promote and support the mission of the NCTN to improve outcomes for patients with cancer, through the following specific aims: 1. to accrue large numbers of patients to NCTN trials, regardless of which Cooperative Group is the coordinating center, with exemplary efficiency and data quality. This includes contributions of detailed biological specimens and cancer imaging/technical data. We have demonstrated a high level of success in this endeavor over several decades within the former cooperative group system, and will continue and further expand upon this productivity. 2. To provide leadership to the NCTN Cooperative Groups and their operations centers, as well as NCI oversight and advisory committees related to clinical trials research. Our faculty members have been and will continue to serve as study chairs, co-chairs, translational research collaborators, committee members and co-investigators for a broad range of clinical trials research within the NCTN system. 3. To collaborate with other members of the NCTN community on innovative, hypothesis-based research that will lead to practice-changing clinical trials. This includes working on bio specimens/translational analyses and clinical secondary analyses from NCTN clinical trials, as well as developing and performing pilot studies that may lead to future late-stage NCTN research (the latter is via collaboration with the Case CCC Developmental Therapeutics Program and the Phase I clinical trials effort (U01CA062502).
Large, federally-funded multicenter national clinical trials are critical to developing practice-changing improvements in cancer care. This is particularly important for addressing questions that are understudied by the private sector, such as advances in surgery, radiation therapy and radiology, and research on rare types of cancer. The participation of major university-based medical centers such as ours will help the national clinical trials system to answer clinical research questions of great importance to improving the quantity and quality of survival of people with cancer.