Villigen

Researchers are evaluating proton therapy compared to standard photon therapy in patients with operable esophageal or gastro-esophageal junction cancer. This international, open-label phase III trial aims to test whether proton therapy can reduce treatment-related lung complications compared to photon therapy. Patients eligible for surgery receive neoadjuvant chemoradiotherapy using either radiation method alongside the same chemotherapy regimen. Participants receive weekly chemotherapy with carboplatin and paclitaxel for 5 weeks. Radiation is delivered either as 41.4 Gy in 23 fractions or 50.4 Gy in 28 fractions, five days per week. Patients are randomized 1:1 to either proton or photon radiation therapy before referral to the appropriate treatment center. The radiation dose regimen is predetermined by each proton center and its assigned photon centers. During the study, participants undergo assessments including PET/CT scans and laboratory tests to confirm eligibility and monitor health. Researchers measure lung complications from the time of randomization until 90 days post-surgery. Follow-up includes monitoring for safety and treatment effects, with surgeries planned as transthoracic esophagectomy or gastrectomy. The study tracks adherence to treatment and follow-up procedures throughout the trial period.