Chemoradiotherapy Versus Esophagectomy After Endoscopic Resection for Superficial Esophageal Squamous Cell Carcinoma
Status:
Recruiting
Trial end date:
2025-12-31
Target enrollment:
Participant gender:
Summary
This is a randomized noninferiority multicenter trial. Patients will be stratified according
to the participating hospital. Patients will be randomized to one of the treatment arms.
Arm A: Patients will receive surgical resection, including Ivor Lewis esophagectomy or
McKeown esophagectomy and systematic lymphadenectomy.
Arm B: Patients will receive 5-fluorouracil (5-FU) and cisplatin-based chemotherapy
concurrently with radiotherapy. Patients will receive cisplatin (45~60mg/m2) intravenously
over 1 hour on day 1 and receive 5-FU (3,200 ~ 4,000mg/m2) intravenously for 4 to 5 days.
Treatment will repeat every 3 weeks for 2 courses. Patients will receive a total of 45 Gy
irradiation (5 days a week for 5 weeks).
Patients will be followed at 3 and 6 months after randomization, then every 6 months for
following 2 and half years (up to 3 years after randomization), and 4 and 5 years after
randomization.