EORTC guidelines for writing protocols for clinical trials of radiotherapy

摘要: The concept of a Master Protocol for phase III studies was raised at the Steering Committee EORTC Radiotherapy Group, in order to make work study coordinators easier, when writing protocols and give them more homogeneity. defines clarifies logical different steps which must be taken designing randomized trial - from rationale references. It pays particular attention eligibility criteria, volumes interest defined agreement with ICRU Report 50 (gross tumor volume, clinical target planning volume organs risk), simulation procedure, treatment technique, normal tissue sparing, dose computation, equipment, specification (also 50). Last but not least, procedures quality assurance patients are also (site visits, dummy run vivo dosimetry, individual case review) allow working plans made advance. We aware that this is exhaustive, hope contents will help those who protocol.