Multicenter Cohort Study of ESD and Chemo-radiotherapy for High-risk Early-stage Esophageal Cancer

Recruiting

• Conditions: Esophagus Cancer
• Interventions: Radiation: chemo-radiation

• Registration Number: NCT06385717
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief Summary

This multicenter, prospective observational cohort study has the potential to optimize individualized chemoradiotherapy regimen for early-stage esophageal cancer patients who have received endoscopic submucosal dissection.

Detailed Description

Our study can further improve the local-regional lymph nodes control rate and alleviate the toxicity of chemoradiotherapy.

Study Timeline

• Status Verified: 2024-04
• Study First Submitted: 2024-04-11
• Study First Submitted QC: 2024-04-25
• Last Update Submitted: 2024-04-25
• Study First Posted: 2024-04-26
• Last Update Posted: 2024-04-26
• Study Start: 2024-05-01
• Primary Completion: 2026-01-31
• Study Completion: 2029-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• 1. Esophageal cancer patients who are pathologically confirmed as pT1a-MM stage or pT1b stage after endoscopic submucosal dissection； 2. No definite contraindications for chemo-radiotherapy； 3. Informed consent has been signed； 4. Refused surgery after endoscopic submucosal dissection.

Exclusion Criteria

• 1. Severe heart, brain, lung disease or renal dysfunction; 2. Previous history of other malignancies; 3. Prior radiation or chemotherapy 4. Researchers consider it inappropriate to participate in this experiment

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Radical chemoradiotherapy	chemo-radiation	Positive vertical margin or unknown margin
Prophylactic chemoradiotherapy	chemo-radiation	pT1a -MM and pT1b-SM1 without pathological risk factors
Intensive chemoradiotherapy	chemo-radiation	pT1b-SM2; pT1a -MM and pT1b-SM1 with pathological risk factors

Primary Outcome Measures

Name	Time	Method
Incidence of toxic events	2026.2	esophageal stenosis, radiation pneumonitis, etc

Secondary Outcome Measures

Name	Time	Method
3-year local-regional recurrence free survival	2029.1	the time from randomization until local-regional recurrence
3-year overall survival	2029.1	the time from randomization until death from any cause

Trial Locations

Locations (2)

The Second Affiliated Hospital of Zhejiang University School of Medicine; 🇨🇳 Hangzhou, Zhejiang, China

The Second Affiliated Hospital of Zhejiang University, School of Medicine; 🇨🇳 Hangzhou, China