EORTC GUIDELINES FOR WRITING PROTOCOLS FOR CLINICAL-TRIALS OF RADIOTHERAPY

The concept of a Master Protocol for phase III studies was raised at t he Steering Committee of the EORTC Radiotherapy Group, in order to mak e the work of the study coordinators easier, when writing protocols an d to give them more homogeneity. The Master Protocol defines and clari fies in a logical order the different steps which must be taken when d esigning a randomized trial - from the rationale to the references. It pays particular attention to eligibility criteria, volumes of interes t defined in agreement with ICRU Report 50 (gross tumor volume, clinic al target volume, planning target volume and organs at risk), simulati on procedure, treatment technique, normal tissue sparing, dose computa tion, equipment, dose specification (also in agreement with ICRU Repor t 50). Last but not least, the different procedures of quality assuran ce for protocols and patients are also defined (site visits, dummy run procedure, in vivo dosimetry, individual case review) to allow workin g plans to be made in advance. We are aware that this work is not exha ustive, but hope that the contents will be of help to those who are wr iting a protocol.