Comparing surgery and radiation for early-stage esophageal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase III trial aims to compare the effectiveness of esophagectomy versus chemoradiation in patients with clinical stage N0 and pathological stage T1b esophageal squamous cell carcinoma following endoscopic submucosal dissection. It is a multi-center, randomized trial that includes two treatment arms: one receiving esophagectomy and the other receiving chemoradiation. Additionally, there is a registry arm for patients and surgeons who prefer not to be randomized. The primary goal is to assess the 5-year overall survival rate between the two treatment options, while secondary outcomes include quality of life and relapse-free survival rates.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Biopsy proven with esophageal squamous cell cancer.
* Clinical N0 stage diagnosed by imaging examinations.
* Pathological T1b stage confirmed by endoscopic submucosal dissection.
* Age: 18-75.
* Tumor located at the thorax.
* Performance status Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
* Written informed consent.

Exclusion Criteria:

* Prior intervention treatment before endoscopic submucosal resection.
* Inability to accept any treatment component.
* Prior intervention (surgery, chemoradiation, et al.) for other primary tumor disease.
* Distant metastasis.
* The circumference of the lumen over 3/4
* Main tumor size \> 5cm assessed by endoscopy
* Inability to understand the informed consent.

Where it's running

• Shanghai Chest Hospital, Shanghai Jiao Tong University
  Shanghai, China Recruiting
• The First Affiliated Hospital of Nanchang University
  Nanchang, Jiangxi, China Active not recruiting
• Changhai Hospital, The Second Military Medical University
  Shanghai, China Active not recruiting
• Ruijin Hospital, Shanghai Jiao Tong University, School of Medicine
  Shanghai, China Active not recruiting
• Zhongshan Hospital, Fudan University
  Shanghai, China Active not recruiting
• Tianjin Medical University Cancer Institute and Hospital
  Tianjin, China Active not recruiting

Study contacts

• Principal investigator: Zhigang Li, MD, PhD — Shanghai Chest Hospital of Shanghai Jiao Tong University
• Study coordinator: Zhigang Li, MD
• Email: dr_lizhigang@163.com
• Phone: 18960619260

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.