Bolla M, Bartelink H, Garavaglia G, Gonzalez D, Horiot J C, Johansson K A, van Tienhoven G, Vantongelen K, van Glabbeke M
Radiotherapy Department, C.H.U. BP 217, Grenoble, France.
Radiother Oncol. 1995 Jul;36(1):1-8. doi: 10.1016/0167-8140(95)01573-y.
The concept of a Master Protocol for phase III studies was raised at the Steering Committee of the EORTC Radiotherapy Group, in order to make the work of the study coordinators easier, when writing protocols and to give them more homogeneity. The Master Protocol defines and clarifies in a logical order the different steps which must be taken when designing a randomized trial--from the rationale to the references. It pays particular attention to eligibility criteria, volumes of interest defined in agreement with ICRU Report 50 (gross tumor volume, clinical target volume, planning target volume and organs at risk), simulation procedure, treatment technique, normal tissue sparing, dose computation, equipment, dose specification (also in agreement with ICRU Report 50). Last but not least, the different procedures of quality assurance for protocols and patients are also defined (site visits, dummy run procedure, in vivo dosimetry, individual case review) to allow working plans to be made in advance. We are aware that this work is not exhaustive, but hope that the contents will be of help to those who are writing a protocol.
在欧洲癌症研究与治疗组织（EORTC）放射治疗小组指导委员会上提出了三期研究主方案的概念，目的是在撰写方案时让研究协调员的工作更轻松，并使方案更具同质性。主方案以逻辑顺序定义并阐明了设计随机试验时必须采取的不同步骤——从理论依据到参考文献。它特别关注入选标准、与国际辐射单位与测量委员会（ICRU）第50号报告一致定义的感兴趣体积（大体肿瘤体积、临床靶体积、计划靶体积和危及器官）、模拟程序、治疗技术、正常组织保护、剂量计算、设备、剂量规范（同样与ICRU第50号报告一致）。最后但同样重要的是，还定义了方案和患者的不同质量保证程序（现场访问、模拟运行程序、体内剂量测定、个案审查），以便提前制定工作计划。我们意识到这项工作并不详尽，但希望其内容能对撰写方案的人有所帮助。
