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A. Dimitrios Colevas, J. Martin Brown, Stephen Hahn, James Mitchell, Kevin Camphausen, C. Norman Coleman, For the Radiation Modifier Working Group of the National Cancer Institute, Development of Investigational Radiation Modifiers, JNCI: Journal of the National Cancer Institute, Volume 95, Issue 9, 7 May 2003, Pages 646–651, https://doi.org/10.1093/jnci/95.9.646
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Historically, clinically useful modifiers of radiation therapy have been conventional chemotherapeutic agents (e.g., 5-fluorouracil and thymidylate synthase inhibitors, cisplatin and related compounds, and taxanes) (1–4) administered on a schedule designed to optimize the interaction between the agent and radiation. The Cancer Therapy Evaluation Program (CTEP) and the Radiation Research Program (RRP) of the Division of Cancer Treatment and Diagnosis, National Cancer Institute, sponsored a meeting of the Radiation Modifier Working Group June 24–26, 2002, in Rosslyn, VA. The charge of the working group was to review and evaluate past and current preclinical and clinical approaches to the development of combination drug and radiation anticancer therapies and to provide practical guidelines for selecting evaluation criteria for radiation modifiers.
Additional potentially useful molecular targets for agents that modify the effects of radiation are emerging as our knowledge of the human genome and proteome continues to expand. Obstacles to development of such agents include the lack of interdisciplinary coordination, publicly available guidelines concerning what constitutes an interesting candidate for development, and up-to-date guidelines concerning appropriate and efficient pathways to define their clinical utilities. This workshop was convened as a cooperative effort between CTEP and RRP to both encourage and facilitate the development of molecular targets for radiation modification. Although the working group focused primarily on the development process as it relates to the mission of CTEP (5), this consensus statement is intended to provide a platform for the relevant governmental, academic, and pharmaceutical medical constituencies worldwide to discuss the development of radiation modifiers rather than define a rigid standard model of drug development in this arena.