Cancer and Leukemia Group B

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Duke University Medical Center is currently completing its fourth grant cycle as a member of Cancer and Leukemia Group B (CALGB). Over the last two decades, Duke has consistently been one of the top five institutions in overall patient accrual. The goal and specific aims of the current application are to continue this high level of patient enrollment, combined with broad scientific participation by our faculty in the development of treatment trials and correlative science studies. An additional aim is to further develop our clinical trials organization by providing broad access to cancer clinical trials, not only at Duke, but also in underserved communities of North Carolina and research affiliates across the Southeast United States through our Duke Oncology Network (DON). In the current grant cycle, 866 patients were enrolled at Duke and nearly 1900 patients across the DON. This high level of clinical commitment to CALGB activities is matched by a high level of scientific participation by Duke Faculty. Particular areas of strength include Breast Cancer and Correlative Studies, Cancer in the Elderly, Leukemia/Lymphoma and Respiratory Cancer and Thoracic Surgery. Faculty recruitment has expanded our strength in all of these areas, as well as provided major growth in Gl and GU cancer programs. Duke faculty have made substantial contributions in CALGB biomarker based studies and genomic based treatment trials. To improve regulatory oversight and efficient use of resources, Duke cancer clinical trials have been reorganized into an Oncology Site Based Research (SBR) entity within the Cancer Center which includes CALGB activities. The SBR/ CALGB oversees disease and site specific clinical research teams at Duke and throughout DON, which includes 10 community sites in North Carolina, staffed by Duke faculty and research nurses, as well as 11 research affiliate sites. This organizational structure has been developed over the last 20 years under the direction of Dr. Jeffrey Crawford, who serves as the Principal Investigator of CALGB activities. Activities at Duke are further enhanced by the close interaction with the CALGB biostatistics and data management center headquartered at Duke, under the direction of Dr. Stephen George, who is also Director of Biostatistics at the Duke Comprehensive Cancer Center. In the next grant cycle, we propose to utilize these resources to further increase our patient enrollment on cooperative group clinical trials, enhance our scientific participation within the group and expand access to clinical trials for underserved populations. RELEVANCE (See instructions): Participation of patients and investigators in cooperative group clinical trials is vital to our understanding of the biology and treatment of cancer. Continued support of both CALGB activities and Duke University's participation in them will enable continued patient enrollment and scientific participation in cancer clinical trials of national importance.