The Radiation Therapy Oncology Group (RTOG) is committed to its role as a Research Base for the Community Clinical Oncology Program (CCOP). This application documents the progress and future plans of the RTOG Cancer Prevention and Control (CPC) program including the development of CPC clinical trials and oversight of CCOP participation in the Group's cancer treatment studies. This application also documents the involvement of RTOG's non-CCOP members in CPC studies. The major focus of RTOG's CPC program is the development of protocols to evaluate novel interventions that decrease or prevent treatment-related acute and late toxicities. These studies reflect the principle that a decrease in toxicity can allow more aggressive therapy and improve outcome. The CPC program is also charged to reduce patient suffering through improved palliation, reduced late tissue effects and a reduced rate of second malignancies. Since the majority of radiotherapy patients are treated in the community setting, CCOP members are essential to the successful implementation of the CPC program. The participation of community-based investigators has also afforded RTOG the opportunity to observe how well new therapies and new technologies, such as radiosurgery and intensity modulated radiation therapy (IMRT), can transfer to the community and for CCOP members to evaluate their effectiveness and morbidity. This application divides the proposed CPC activities into four sections: interventions to decrease patient suffering symptom management;prevention and reduction of late effects to cancer therapy;chemoprevention of second malignancies;and, integrative oncology - complementary and alternative medicine (CAM). The symptom management studies will continue to dominate the CPC activities;the late effects program will study the role of cytokine profiles in predicting late effects;the chemoprevention program will address the potential of a Cox-2 inhibitor as a chemoprevention agent;and the integrative oncology program will continue to conduct rigorous controlled studies to document the effectiveness of CAM for radiation therapy patients. The CPC program is directed by the RTOG Vice-Chair for CPC, as well Chairs for each section and a CPC Steering Committee. The CCOP Membership Committee evaluates the CCOPs to assure adherence to all NCI requirements. The RTOG Administrative, Protocol Development and Regulatory Compliance, Quality Assurance, Data Management, and Statistical Units are utilized in the development and monitoring of CPC trials, and RTOG quality assurance procedures, including on-site audits, are applied to the CCOPs. The goal of the RTOG CCOP program is to design and implement CDC studies and to integrate community institutions into RTOG's scientific program.
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