A Prospective Randomized Controlled Clinical Study Comparing Radical Chemoradiotherapy Alone and Combined With Consolidation Chemotherapy for Non-surgical Esophageal Squamous Cell Carcinoma

What this Trial Is About

Researchers are evaluating treatments for esophageal squamous cell carcinoma, focusing on patients who cannot have surgery or refuse it. This phase III, multicenter, prospective randomized controlled study compares radical chemoradiotherapy alone versus combined with consolidation chemotherapy, aiming to observe and compare survival times and side effects. The study targets tumors classified from stage T2N0M0 to TxNxM0 according to the 2017 AJCC staging criteria. Participants are assigned to one of two groups. Group A receives radical chemoradiotherapy, which includes concurrent chemotherapy using Lipusu T and Cisplatin DDP over two cycles, alongside intensity modulated radiotherapy. Group B receives the same initial treatment followed by four cycles of consolidation chemotherapy after a rest period of 2 to 3 weeks. Radiotherapy doses range from 50 to 60 Gy using conventional fractionation. During the study, participants undergo assessments for overall survival at 3 and 5 years, as well as progression-free survival, objective response rate, disease control rate, side effects, and quality of life. Researchers monitor safety, side effects, and treatment responses over the course of the study, which lasts several years. Participants are followed closely to evaluate these outcomes and the impact of treatments on their health.

Comparison of Chemoradiotherapy and Chemoradiotherapy Combined With Consolidation Chemotherapy for ESCC