Comparison of Chemoradiotherapy Followed by Planned Surgery Versus Chemoradiotherapy With Surgery as Needed for Treating Locally Advanced Esophageal Squamous Cell Carcinoma

What this Trial Is About

Researchers are comparing two treatment approaches for patients with resectable locally advanced squamous cell carcinoma of the esophagus. The trial aims to assess overall survival, quality of life, and eating restrictions after different chemoradiotherapy and surgery strategies. This phase III, randomized, open-label study hopes to guide future clinical practice for this condition. One group receives neoadjuvant chemoradiotherapy followed by planned esophagectomy. Radiotherapy is delivered in 1.8 Gy fractions five days a week for 23 sessions, combined with weekly carboplatin and paclitaxel chemotherapy. The second group undergoes definitive chemoradiotherapy with surveillance esophagectomy is performed only if cancer remains or recurs. Radiotherapy in this group follows one of two dosing schedules, combined with one of three chemotherapy regimens including carboplatin-paclitaxel, cisplatin-5-fluorouracil, or FOLFOX. Participants are monitored for overall survival three years after randomization, and their global health-related quality of life and eating restrictions one year after starting treatment. Additional assessments include quality of life evaluations up to five years, event-free survival, relapse rates, treatment side effects, surgical complications, and nutritional outcomes. The study involves repeated evaluations and follow-up over several years to capture long-term effects of the treatments.

Chemoradiotherapy Followed by Planned Surgery or by Surveillance and Surgery Only When Needed for Oesophageal Cancer