Radiotherapy quality assurance in the PROTECT trial - a European randomised phase III-trial comparing proton and photon therapy in the treatment of patients with oesophageal cancer

Purpose:To present results from the trial radiotherapy quality assurance (RTQA) programme of the centres involved in the randomised phase-III PROton versus photon Therapy for esophageal Cancer - aTrimodality strategy (PROTECT)-trial, investigating the clinical effect of proton therapy (PT) vs. photon therapy (XT) for patients with oesophageal cancer. Materials and methods: The pre-trial RTQA programme consists of benchmark target and organ at risk (OAR) delineations as well as treatment planning cases, a facility questionnaire and beam output audits. Continuous on-trial RTQA with individual case review (ICR) of the first two patients and every fifth patient at each participating site is performed. Patient-specific QA is mandatory for all patients. On-site visits are scheduled after the inclusion of the first two patients at two associated PT and XT sites. Workshops are arranged annually for all PROTECT participants. Results: Fifteen PT/XT sites are enrolled in the trial RTQA programme. Of these, eight PT/XT sites have completed the entire pre-trial RTQA programme. Three sites are actively including patients in the trial. On-trial ICR was performed for 22 patients. For the delineation of targets and OARs, six major and 11 minor variations were reported, and for six patients, there were no remarks. One major and four minor variations were reported for the treatment plans. Three site visits and two annual workshops were completed. Interpretation: A comprehensive RTQA programme was implemented for the PROTECT phase III trial. All centres adhered to guidelines for pre-trial QA. For on-trial QA, major variations were primarily seen for target delineations (< 30%), and no treatment plans required re-optimisation.