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Recruiting NCT06385717

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

— Observational Esophagus Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: chemo-radiation.
Who it may be relevant to
Registry conditions: Esophagus Cancer. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Multicenter Cohort Study of Chemo-radiotherapy After Endoscopic Submucosal Dissection for High-risk Early-stage Esophageal Cancer

Overview

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.

Interventions

  • Radiation chemo-radiation
    different Chemo-radiotherapy regimen

Primary outcome measures

  • Incidence of toxic events [Time frame: 2026.2]
Secondary outcome measures (2)
  • 3-year overall survival [Time frame: 2029.1]
  • 3-year local-regional recurrence free survival [Time frame: 2029.1]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 2 centers
  • The Second Affiliated Hospital of Zhejiang University School of Medicine — Hangzhou
  • The Second Affiliated Hospital of Zhejiang University, School of Medicine — Hangzhou

Identifiers

NCT: NCT06385717 · ZhejiangU

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗