Service de cancérologie-radiothérapie, hôpital Saint-Louis, université de Paris, 1, avenue Claude-Vellefaux, 75010 Paris, France.
IRCM Inserm U1194, Fédération universitaire d'oncologie radiothérapie Montpellier-Nîmes (Forom), Institut du cancer de Montpellier (ICM), université de Montpellier, 34000 Montpellier, France.
Cancer Radiother. 2022 Feb-Apr;26(1-2):104-107. doi: 10.1016/j.canrad.2021.11.011. Epub 2021 Dec 23.
The aim of this review is to present the specificities of clinical research in radiation oncology. Objectives are similar to all research in oncology: to improve the efficacy and to decrease toxic effects. Phase III trials remain the main methodology to demonstrate an improvement in efficiency, but phase I-II and registers are also important tools to validate an improvement in the therapeutic index with new technologies. In this article we discuss the special features of end-points, selection of population, and design for radiation oncology clinical trials. Quality control of delivered treatments is an important component of these protocols. Financial issues are also discussed, in the particular context of France.
本文旨在介绍放射肿瘤学临床研究的特点。其目标与肿瘤学的所有研究相似，即提高疗效，降低毒副作用。III 期临床试验仍然是证明疗效提高的主要方法，但 I-II 期临床试验和登记处也是验证新技术治疗指数改善的重要工具。本文讨论了放射肿瘤学临床试验终点、人群选择和设计的特点。治疗方案的质量控制是这些方案的一个重要组成部分。本文还讨论了法国特定背景下的财务问题。
