Phase 3 Study Comparing Proton Beam Therapy and Intensity Modulated Photon Radiotherapy for Treating Stage I to IVA Esophageal Cancer

What this Trial Is About

Researchers are comparing two types of radiation therapy, proton beam radiation therapy PBT and intensity modulated photon radiotherapy IMRT, to treat patients with stage I to IVA esophageal cancer. The study aims to find out whether PBT improves overall survival and causes fewer serious heart and lung side effects compared to IMRT. Additional goals include examining symptom burden, quality of life, tumor response, cost-effectiveness, hospitalization length, lymphocyte levels, and rates of treatment failures and complications. Participants are randomly assigned to one of two groups. One group receives PBT over 28 treatment sessions, five days a week for 5.5 weeks, combined with chemotherapy chosen by the patient and their doctor. The other group receives IMRT on the same schedule with similar chemotherapy options. After chemoradiation, patients may have surgery to remove the esophagus tumor if they are eligible. Throughout the study, blood samples and imaging scans PETCT or CT are collected. Participants are closely monitored during treatment and followed for up to eight years. Follow-up visits occur every 3 to 6 months for the first three years and annually thereafter. The study measures overall survival, heart and lung side effects, symptom changes, tumor response, hospitalization time, immune cell counts, and quality-adjusted life years. The study also collects biospecimens for future research on treatment complications and assesses economic factors related to each radiation therapy.

Comparing Proton Therapy to Photon Radiation Therapy for Esophageal Cancer