3 OVERALL REVIEW CRITERIA AND IMPACT 3 FUNDING OPPORTUNITY ANNOUNCEMENT (FOA) SPECIFIC CRITERA 9 ORGANIZATION AND STRUCTURE 9 CLINICAL TRIALS RESEARCH PROGRAM 10 CANCER CARE DELIVERY RESEARCH PROGRAM 11 OPERATIONS/DATA MANAGEMENT CORE 12 ADDITIONAL REVIEW CRITERIA: 14 PROTECTIONS FOR HUMAN SUBJECTS 14 INCLUSION OF WOMEN, MINORITIES, AND CHILDREN 14 RESOURCE SHARING PLAN 14 BUDGET AND PERIOD OF SUPPORT 14 SPECIAL EMPHASIS PANEL ROSTER DESCRIPTION (provided by applicant): The Medical University of South Carolina/Hollings Cancer Center (MUSC/HCC), a National Cancer Institute (NCI)-designated cancer center since 2009, has been a long-standing NCI cooperative group participant and is well positioned to be a leading Minority/Underserved Community Site within the NCI's Community Oncology Research Program (NCORP). Originally a main member of CALGB (1985-2002), in 2002 MUSC/HCC became a main member of SWOG. In subsequent years, MUSC/HCC became a main member of COG, RTOG, ACoSOG, ACRIN, NSABP and is also an affiliate member of GOG. The overall growth in accrual across all of these NCI sponsored programs has been significant with 134 enrollments in the most recent annual reporting period, of which 28% were ethnic/racial minorities. A major asset that MUSC/HCC and its partnering sites - MUSC/HCC East Cooper, MUSC/HCC North Charleston, Ralph H. Johnson Veterans Administration Medical Center, MUSC/Hilton Head Breast Health Center, Georgetown Health System, and Self Regional Healthcare - bring to the NCORP is its demonstrable ability to reach an ethnic/minority cancer population (32% in its catchment area) and a federally designated underserved/rural cancer population (43% in its catchment area). Another major asset that MUSC/HCC brings to the NCORP program is its considerable expertise and leadership in the development and implementation of cancer disparities and cancer care delivery research (CCDR). MUSC/HCC investigators have a robust portfolio of NCI and other peer-reviewed funded initiatives in these focal areas, enrolling more than 500 individuals in the last year, and are poised to collaborate with NCORP research bases in the development and implementation of additional CCDR research. Finally, MUSC/HCC has invested considerable resources to its centralized clinical research operation. It is capable of managing a large portfolio of studies and has repeatedly demonstrated high quality compliance and data through its external audits during the past decade. The MUSC/HCC Clinical Trials Office will provide an effective and efficient infrastructure to support investigators and clinicians in implementing clinical trials and CCDR within the NCORP.
Establishing MUSC/HCC as a Minority/Underserved Community Site within the NCI's Community Oncology Research Program (NCORP) will provide greater emphasis and availability for residents and healthcare providers of South Carolina to participate in cancer prevention, control, screening, post treatment surveillance, cancer care delivery, treatment, and imaging research studies.
|West, Howard L; Moon, James; Wozniak, Antoinette J et al. (2018) Paired Phase II Studies of Erlotinib/Bevacizumab for Advanced Bronchioloalveolar Carcinoma or Never Smokers With Advanced Non-Small-cell Lung Cancer: SWOG S0635 and S0636 Trials. Clin Lung Cancer 19:84-92|
|Henry, N Lynn; Unger, Joseph M; Schott, Anne F et al. (2018) Randomized, Multicenter, Placebo-Controlled Clinical Trial of Duloxetine Versus Placebo for Aromatase Inhibitor-Associated Arthralgias in Early-Stage Breast Cancer: SWOG S1202. J Clin Oncol 36:326-332|
|Hussain, Maha; Tangen, Catherine M; Thompson Jr, Ian M et al. (2018) Phase III Intergroup Trial of Adjuvant Androgen Deprivation With or Without Mitoxantrone Plus Prednisone in Patients With High-Risk Prostate Cancer After Radical Prostatectomy: SWOG S9921. J Clin Oncol 36:1498-1504|
|Danilov, Alexey V; Li, Hongli; Press, Oliver W et al. (2017) Feasibility of interim positron emission tomography (PET)-adapted therapy in HIV-positive patients with advanced Hodgkin lymphoma (HL): a sub-analysis of SWOG S0816 Phase 2 trial. Leuk Lymphoma 58:461-465|
|Ravandi, Farhad; Othus, Megan; O'Brien, Susan M et al. (2016) US Intergroup Study of Chemotherapy Plus Dasatinib and Allogeneic Stem Cell Transplant in Philadelphia Chromosome Positive ALL. Blood Adv 1:250-259|
|Achille, Nicholas J; Othus, Megan; Phelan, Kathleen et al. (2016) Association between early promoter-specific DNA methylation changes and outcome in older acute myeloid leukemia patients. Leuk Res 42:68-74|
|Press, Oliver W; Li, Hongli; Schöder, Heiko et al. (2016) US Intergroup Trial of Response-Adapted Therapy for Stage III to IV Hodgkin Lymphoma Using Early Interim Fluorodeoxyglucose-Positron Emission Tomography Imaging: Southwest Oncology Group S0816. J Clin Oncol 34:2020-7|
|Ben-Josef, Edgar; Guthrie, Katherine A; El-Khoueiry, Anthony B et al. (2015) SWOG S0809: A Phase II Intergroup Trial of Adjuvant Capecitabine and Gemcitabine Followed by Radiotherapy and Concurrent Capecitabine in Extrahepatic Cholangiocarcinoma and Gallbladder Carcinoma. J Clin Oncol 33:2617-22|