Proton Versus Photon Tender

Grant agreement ID 101008134Start date 1 July 2021End date 30 June 2027Overall budget 4 763 73375 ObjectiveThe aim of PROTECT-trial is to compare the clinical outcome of proton therapy PT and conventional radiotherapy in a randomized study and to use the data and experience to advance the field of evidence-based medicine in PT. A randomized trial with 396 patients is planned involving 13 recruiting units and 34 institutions from nine European countries in an accrual period of three years. All involved PT centers have state-of-the-art equipment including pencil beam scanning and volumetric image guidance. The endpoints will include side effects tumor control survival and health economics aspects. PROTECT-trial will use experience from the trial combined with parallel experience from other trial methodologies to create a consensus model for the selection of patients both for referral for standard PT and for enrollment in clinical trials. This model will be based on esophageal cancer but will have wider implications which can be used in all European countries and for other cancer types. PROTECT-trial will result in new evidence for the role of PT in cancer management. PROTECT-trial will advance the quality of care for trimodality management of esophageal cancer. The large trial will provide statistically robust results at a high level of clinical evidence and will allow a successful trial to trigger an international change in clinical practice. If the PROTECT trial is positive PT will become a standard option for a large patient population. The patients will recover faster from their treatment and live a better life with fewer side effects and more years at work. The results will have high relevance for other cancer types where protons also lower the dose to sensitive normal tissues. Notably PROTECT-trial will actively engage with patients providers payers and other stakeholders to design and report the study. Finally PROTECT-trial will contribute with Health Technology Assessment and provide economic evidence of high relevance to reimbursement decisions in Europe.