Davis J Bernard, Reiner Béatrice, Dusserre Andrée, Giraud Jean-Yves, Bolla Michel
Radiation Oncology, University Hospital Zurich, Ramistrasse 100, 8091, Zurich, Switzerland.
Radiother Oncol. 2002 Jul;64(1):65-73. doi: 10.1016/s0167-8140(02)00143-3.
A dry run of a clinical trial (EORTC 22911) is presented in which 12 centres have participated. These are the centres which have contributed the largest number of patients to the trial.
Each participating centre received data from a suitable patient. Investigators were asked to plan and 'treat' the patient according to the protocol guidelines and return the data for evaluation of compliance.
The results show that compliance to the protocol guidelines was generally good. There were a few minor deviations in the dose and fractionation schedule, in the volume reduction for the booster dose and in the dose prescription point. None of these deviations will affect the outcome of the study. The most important observation is the large inter-centre variation in target volumes.
The results of this study underlines the need for a strict definition of the target volume and the adoption of the ICRU 50 recommendations in future protocols.
介绍了一项临床试验（EORTC 22911）的预演，有12个中心参与其中。这些是为该试验贡献患者数量最多的中心。
每个参与中心接收来自一名合适患者的数据。要求研究者根据方案指南对患者进行规划和“治疗”，并返回数据以评估依从性。
结果表明，对方案指南的依从性总体良好。在剂量和分割方案、增强剂量的体积减少以及剂量处方点方面存在一些小偏差。这些偏差均不会影响研究结果。最重要的观察结果是靶体积在各中心之间存在很大差异。
本研究结果强调了在未来方案中严格定义靶体积并采用ICRU 50建议的必要性。
