The goal of this application is to provide support for scientific leadership and clinical trial infrastructure within the Duke Cancer Institute in the development and conduct of clinical trials as part of the National Clinical Trials Network (NCTN). The studies will concentrate on definitive, randomized, late Phase clinical treatment and advanced imaging trials in oncology in association with multiple adult Network Groups. The award will further Duke's continued substantial accrual to clinical trials funded by the NCI, and specifically trials conducted across the entire National Clinical Trials Network (NCTN) as part of NCI's overall clinical research program for adults and children with cancer. An important focus will be an emphasis on trials in special populations, including under-served populations and rare tumors. The leadership of the 5 Principal Investigators named in the grant application, along with the faculty of the 9 NCI approved research programs at Duke and the Duke Central Cooperative Group Office will provide a strong and efficient backbone for NCTN clinical research scientific leadership and patient enrollment effort. Our continued participation as a member of the Alliance (formerly CALGB, ACOSOG and NCCTG), GOG, NSABP and RTOG (soon to be NRG), ACRIN (now ECOG-ACRIN) and enrollment in trials offered by all current adult NCI funded Cooperative Groups through the CTSU mechanism, gives Duke the experience and knowledge needed to lead and enroll in complex NCI funded research involving multiple cancers sites and treatment modalities. The definitive evaluation of newly developed therapies for cancer care including multi-modality treatments, combinations of novel agents, and molecularly-based treatment and advanced imaging approaches, will benefit patients and practitioners as well as the entire oncology research community. This grant will also help to foster an ideal environment to enhance multidisciplinary collaborations and develop the next generation of clinical investigators dedicated to cancer research. The support provided to Duke as a lead academic site will be leveraged against the significant scientific and clinical resources of the Duke Cancer Institute to provide robust participation in a nationally established clinical trial program.

Public Health Relevance

Participation of patients and investigators in NCTN clinical trials is vital to our understanding of the biology and treatment of cancer. Support of NCTN leadership activities of Duke Faculty and clinical research staff effort will help us maintain our high patient enrollment and robust scientific participation in clinical trials of national importane.

National Institute of Health (NIH)
National Cancer Institute (NCI)
Cooperative Clinical Research--Cooperative Agreements (U10)
Project #
Application #
Study Section
Special Emphasis Panel (ZCA1)
Program Officer
Mooney, Margaret M
Project Start
Project End
Budget Start
Budget End
Support Year
Fiscal Year
Total Cost
Indirect Cost
Duke University
Internal Medicine/Medicine
Schools of Medicine
United States
Zip Code
Morrison, Vicki A; McCall, Linda; Muss, Hyman B et al. (2018) The impact of actual body weight-based chemotherapy dosing and body size on adverse events and outcome in older patients with breast cancer: Results from Cancer and Leukemia Group B (CALGB) trial 49907 (Alliance A151436). J Geriatr Oncol 9:228-234
Sparano, Joseph A; Gray, Robert J; Makower, Della F et al. (2018) Adjuvant Chemotherapy Guided by a 21-Gene Expression Assay in Breast Cancer. N Engl J Med 379:111-121
Li, Daneng; McCall, Linda M; Hahn, Olwen M et al. (2018) Identification of risk factors for toxicity in patients with hormone receptor-positive advanced breast cancer treated with bevacizumab plus letrozole: a CALGB 40503 (alliance) correlative study. Breast Cancer Res Treat 171:325-334
Choueiri, Toni K; Hessel, Colin; Halabi, Susan et al. (2018) Cabozantinib versus sunitinib as initial therapy for metastatic renal cell carcinoma of intermediate or poor risk (Alliance A031203 CABOSUN randomised trial): Progression-free survival by independent review and overall survival update. Eur J Cancer 94:115-125
Vasu, Sumithira; Kohlschmidt, Jessica; Mrózek, Krzysztof et al. (2018) Ten-year outcome of patients with acute myeloid leukemia not treated with allogeneic transplantation in first complete remission. Blood Adv 2:1645-1650
Innocenti, Federico; Jiang, Chen; Sibley, Alexander B et al. (2018) Genetic variation determines VEGF-A plasma levels in cancer patients. Sci Rep 8:16332
Basch, Ethan; Dueck, Amylou C; Rogak, Lauren J et al. (2018) Feasibility of Implementing the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events in a Multicenter Trial: NCCTG N1048. J Clin Oncol :JCO2018788620
Wong, Yu-Ning; Manola, Judith; Hudes, Gary R et al. (2018) Phase 2 Study of Weekly Paclitaxel Plus Estramustine in Metastatic Hormone-Refractory Prostate Carcinoma: ECOG-ACRIN Cancer Research Group (E1898) Trial. Clin Genitourin Cancer 16:e315-e322
Gajra, Ajeet; McCall, Linda; Muss, Hyman B et al. (2018) The preference to receive chemotherapy and cancer-related outcomes in older adults with breast cancer CALGB 49907 (Alliance). J Geriatr Oncol 9:221-227
Tallarico, Michael; Foster, Jared C; Seisler, Drew et al. (2018) Frequency and impact of grade three or four toxicities of novel agents on outcomes of older patients with chronic lymphocytic leukemia and non-Hodgkin lymphoma (alliance A151611). J Geriatr Oncol 9:321-328

Showing the most recent 10 out of 31 publications