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ACTIVE NOT RECRUITING
NCT03306901
NA

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

Sponsor: Samsung Medical Center

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

19 Years - 79 Years

Study Type

INTERVENTIONAL

Enrollment

240

Start Date

2017-10-20

Completion Date

2033-12-31

Last Updated

2024-05-23

Healthy Volunteers

No

Interventions

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)

Locations (9)

National Cancer Center

Goyang-si, South Korea

Pusan National University Hospital

Pusan, South Korea

Seoul National University Bundang Hospital

Seongnam, South Korea

Asan Medical Center

Seoul, South Korea

Gangnam Severance Hospital

Seoul, South Korea

Korea University Guro Hospital

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Seoul National University Hospital

Seoul, South Korea

Seoul St. Mary's Hospital

Seoul, South Korea