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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial population

Esophageal cancer patients, and pathologic-comfirmed pT1a-MM stage or pT1b stage

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • chemo-radiation

    Radiation

    different Chemo-radiotherapy regimen

Treatment groups

120 Participants
are divided into 3 treatment groups
Group A: Prophylactic chemoradiotherapy1 intervention
Group B: Intensive chemoradiotherapy1 intervention
Group C: Radical chemoradiotherapy1 intervention

Trial outcomes

Primary outcomes

1

Incidence of toxic events

esophageal stenosis, radiation pneumonitis, etc

Time frame
2026.2

Secondary outcomes

1

3-year overall survival

the time from randomization until death from any cause

Time frame
2029.1
2

3-year local-regional recurrence free survival

the time from randomization until local-regional recurrence

Time frame
2029.1

Other outcomes

Sponsors and contacts

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