Comparing Proton and Photon Chemoradiotherapy in Operable Esophageal Cancer International Randomized Phase III Study of Pre-Surgery Treatments

What this Trial Is About

Researchers are evaluating whether proton therapy PT can reduce treatment-related lung complications compared to standard photon therapy XT in patients with operable esophageal or gastro-esophageal junction cancer. This international, multicenter, phase III study compares neoadjuvant chemoradiotherapy using either photons or protons, aiming to improve outcomes by reducing damage to healthy tissues during radiation treatment. Participants receive neoadjuvant chemoradiotherapy with weekly carboplatin and paclitaxel for five cycles, combined with either photon or proton radiotherapy. Radiation doses are either 41.4 Gy in 23 fractions or 50.4 Gy in 28 fractions, given five days per week. Patients are randomly assigned to either the photon or proton therapy group, with treatment regimens standardized across centers. Surgery follows the chemoradiotherapy, with planned transthoracic esophagectomy or gastrectomy. During the study, patients undergo regular evaluations including imaging FDG PETCT, laboratory tests, and assessments of lung and cardiovascular health. Researchers monitor for lung complications from randomization until 90 days after surgery, as well as other outcomes like early and late toxicity, complications, cardiovascular events, treatment compliance, and survival over up to five years. The study involves careful follow-up to assess the safety and effects of each treatment approach.

PROton Versus Photon Therapy for Esophageal Cancer - a Trimodality Strategy