The Comprehensive Cancer Center of Wake Forest University (CCCWFU) Community Clinical Oncology Program (CCOP) Research Base was funded in 9/99 (retroactive to 6/99) for three years. This application describes the administrative structure, including safety and monitoring procedures and clinical research activities of the Research Base for its five-year competitive renewal as a control/treatment CCOP Research Base. Participants in the Research Base include three CCOPs (Southeast Cancer Control Consortium, Winston-Salem, NC; Upstate Carolina CCOP, Spartanburg, SC; Greenville CCOP, Greenville SC) and four non-CCOP Prevention Members (East Carolina University, Greenville, NC; High Point Regional Health System, High Point, NC; InterCommunity Cancer Center, Rome, GA; WakeMed System, Cary, NC. The geographic region covered by these three CCOPs and four Prevention Members includes seven states (NC, SC, VA, WV, KY, TN, GA) with a population of approximately 12 million people, one-quarter of whom are minorities (60% minorities in coastal NC communities), served by 28 cancer centers. It is anticipated that an additional 3-6 CCOPs and Minority-Based CCOPs will join the CCCWFU CCOP Research Base by 12/01. Active and developing clinical trials of the Research Base are described in the application. In cancer control, there are 4 active and 13 developing studies, focusing on the following areas: complimentary and alternative medicine, symptom management, and quality of life, particularly in the setting of cancer related fatigue, anorexia/weight loss, depression, hot flashes, cognition and chemoprevention. In cancer treatment, there are 6 active and 7 developing studies, focusing on complementary, alternative, and conventional therapies primarily in lung, pancreas, and brain cancer. The spectrum of clinical research studies offered by the CCCWFU CCOP Research Base is complementary to, rather than competitive with, the cancer control/treatment protocols offered by the Cooperative Group Research Bases. Under the direction of Principal Investigator Edward G. Shaw, M.D., the Clinical Research Management administrative structure of the CCCWFU, and key leadership from the CCCWFU, CCOPs, and Prevention Members, the CCCWFU CCOP Research Base is fulfilling its primary goal of providing state-of-the-art intervention oriented clinical research studies in cancer prevention/control to CCOPs and patients (including minorities) in the Southeast United States.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Cooperative Clinical Research--Cooperative Agreements (U10)
Project #
3U10CA081851-06S3
Application #
7275780
Study Section
Special Emphasis Panel (ZCA1)
Program Officer
Kelaghan, Joseph
Project Start
1999-09-07
Project End
2007-05-31
Budget Start
2004-08-28
Budget End
2007-05-31
Support Year
6
Fiscal Year
2006
Total Cost
$1,573,363
Indirect Cost
Name
Wake Forest University Health Sciences
Department
Radiation-Diagnostic/Oncology
Type
Schools of Medicine
DUNS #
937727907
City
Winston-Salem
State
NC
Country
United States
Zip Code
27157
Datta, Mridul; Shaw, Edward G; Lesser, Glenn J et al. (2018) A Randomized Double-Blind Placebo-Controlled Trial of Fruit and Vegetable Concentrates on Intermediate Biomarkers in Head and Neck Cancer. Integr Cancer Ther 17:115-123
Lawrence, J A; Griffin, L; Balcueva, E P et al. (2016) A study of donepezil in female breast cancer survivors with self-reported cognitive dysfunction 1 to 5 years following adjuvant chemotherapy. J Cancer Surviv 10:176-84
Minasian, Lori M; Tangen, Catherine M; Wickerham, D Lawrence (2015) Ongoing Use of Data and Specimens From National Cancer Institute-Sponsored Cancer Prevention Clinical Trials in the Community Clinical Oncology Program. Semin Oncol 42:748-63
Greven, Kathryn M; Case, L Douglas; Nycum, Lawrence R et al. (2015) Effect of ArginMax on sexual functioning and quality of life among female cancer survivors: results of the WFU CCOP Research Base Protocol 97106. J Community Support Oncol 13:87-94
Rapp, Stephen R; Case, L Doug; Peiffer, Ann et al. (2015) Donepezil for Irradiated Brain Tumor Survivors: A Phase III Randomized Placebo-Controlled Clinical Trial. J Clin Oncol 33:1653-9
Peiffer, Ann M; Leyrer, C Marc; Greene-Schloesser, Dana M et al. (2013) Neuroanatomical target theory as a predictive model for radiation-induced cognitive decline. Neurology 80:747-53
Spigel, David R; Ervin, Thomas J; Ramlau, Rodryg A et al. (2013) Randomized phase II trial of Onartuzumab in combination with erlotinib in patients with advanced non-small-cell lung cancer. J Clin Oncol 31:4105-14
O'Flaherty, Joseph T; Wooten, Rhonda E; Samuel, Michael P et al. (2013) Fatty acid metabolites in rapidly proliferating breast cancer. PLoS One 8:e63076
Vitolins, Mara Z; Griffin, Leah; Tomlinson, W Vic et al. (2013) Randomized trial to assess the impact of venlafaxine and soy protein on hot flashes and quality of life in men with prostate cancer. J Clin Oncol 31:4092-8
Lesser, Glenn J; Case, Doug; Stark, Nancy et al. (2013) A randomized, double-blind, placebo-controlled study of oral coenzyme Q10 to relieve self-reported treatment-related fatigue in newly diagnosed patients with breast cancer. J Support Oncol 11:31-42

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