Last updated on April 2019

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


Brief description of study

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 (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.

Detailed Study Description

  • Compare 3-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 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

Clinical Study Identifier: NCT03306901

Find a site near you

Start Over

National Cancer Center

Goyang-si, Korea, Republic of
  Connect »

Asan Medical Center

Seoul, Korea, Republic of
  Connect »

Gangnam Severance Hospital

Seoul, Korea, Republic of
  Connect »

Samsung Medical Center

Seoul, Korea, Republic of
  Connect »

Seoul St. Mary's Hospital

Seoul, Korea, Republic of
  Connect »

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


Receive Emails About New Clinical Trials!

Sign up for our FREE service to receive email notifications when clinical trials are posted in the medical category of interest to you.