NCT03306901

Chemoradiotherapy Versus Esophagectomy After Endoscopic Resection for Superficial Esophageal Squamous Cell Carcinoma

A Randomized Multicenter Noninferiority Trial Comparing Chemoradiotherapy Versus Esophagectomy After Endoscopic Submucosal Dissection for Superficial Esophageal Squamous Cell Carcinoma (ASSURE)

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: Samsung Medical Center · Academic / Other
• Sex: All
• Age: 19 Years – 79 Years
• Healthy volunteers: Not accepted

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. After 5 years, annual follow-up is scheduled up to 10 years after randomization. We will analyze the results primarily with the intention-to-treatment(ITT) analysis, and then secondarily with the per-protocol(PP) analysis as well.

Detailed description

* Compare 1-year, 2-year, 3-year, 5-year, 6-year, 7-year, 8-year, 9-year, 10-year overall survival between concurrent chemoradiotherapy and esophagectomy among patients who require additional treatment for esophageal squamous cell carcinoma endoscopically resected but found to have pT1b (submucosal invasion) or lymphovascular invasion * Compare 1-year, 2-year, 3-year, 5-year, 6-year, 7-year, 8-year, 9-year, 10-year disease-free survival between concurrent chemoradiotherapy and esophagectomy in the same study population * Compare quality of life between concurrent chemoradiotherapy and esophagectomy in the same study population * Compare treatment-related adverse event between concurrent chemoradiotherapy and esophagectomy in the same study population

Conditions

• Esophageal Cancer

Interventions

Type	Name	Description
PROCEDURE	Esophagectomy	Ivor Lewis esophagectomy or McKeown esophagectomy and systematic lymphadenectomy
DRUG	5-fluorouracil	3,200 \~ 4,000mg/m2 intravenously for 4 to 5 days.
DRUG	Cisplatin	45\~60mg intravenously over 1 hour on day 1
RADIATION	Radiation therapy	45 Gy irradiation (5 days a week for 5 weeks)

Timeline

• Start date: 2017-10-20
• Primary completion: 2025-12-31
• Completion: 2033-12-31
• First posted: 2017-10-11
• Last updated: 2024-05-23

Locations

9 sites across 1 country: South Korea