Actively Recruiting
Phase III Trial Comparing Chemoradiotherapy with and without Prophylactic Irradiation for Early-Stage Esophageal Squamous Cell Carcinoma
Led by National Cancer Center, Japan · Updated on 2025-05-22
280
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating whether modified chemoradiotherapy with elective nodal irradiation can reduce locoregional recurrence in patients with clinical T1bN0M0 esophageal squamous cell carcinoma that cannot be fully removed by salvage endoscopic resection, while preserving the esophagus without affecting overall survival. This is a randomized controlled Phase III trial focused on this specific stage of esophageal cancer. The trial compares two chemoradiotherapy regimens one with elective nodal irradiation and one with involved field irradiation. Both use chemotherapy drugs 5-FU and CDDP given on specified days, combined with radiotherapy delivered in fractions totaling either 50.4 Gy or 60 Gy. The study aims to assess the impact of adding prophylactic irradiation to the standard local field treatment. Participants will undergo clinical evaluations including imaging and endoscopy to diagnose and monitor the cancer. Major outcomes measured include progression-free survival, overall survival, complete response rate, esophagectomy-free survival, adverse events, and long-term toxicity. The primary analysis will occur five years after the last patient enrollment, allowing comprehensive monitoring of treatment effects and safety over time.
CONDITIONS
Brief Title
A Randomized Controlled Trial Evaluating of Prophylactic Irradiation in CRT for cT1bN0M0 ESCC
Research Team
M
Motoo Nomura, MD/PhD
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
