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

NCT06385717 | Recruiting

• 1 other identifier: ZhejiangU
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 2

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.

Conditions

Esophagus Cancer

Keywords

esophagus cancer; radio-chemotherapy; ESD

Outcome Measures

Primary Outcomes (1)

• Incidence of toxic events

  esophageal stenosis, radiation pneumonitis, etc

  2026.2

Secondary Outcomes (2)

• 3-year overall survival

  2029.1

• 3-year local-regional recurrence free survival

  2029.1

Study Arms (3)

Prophylactic chemoradiotherapy

pT1a -MM and pT1b-SM1 without pathological risk factors

Radiation: chemo-radiation

Intensive chemoradiotherapy

pT1b-SM2; pT1a -MM and pT1b-SM1 with pathological risk factors

Radiation: chemo-radiation

Radical chemoradiotherapy

Positive vertical margin or unknown margin

Radiation: chemo-radiation

Interventions

chemo-radiation RADIATION

different Chemo-radiotherapy regimen

Intensive chemoradiotherapy; Prophylactic chemoradiotherapy; Radical chemoradiotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• \. 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.

You may not qualify if:

• \. 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

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (2)

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310000, China

RECRUITING

The Second Affiliated Hospital of Zhejiang University, School of Medicine

Hangzhou, China

NOT YET RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

pathological tissue

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Officials

• Jing Xu, MD

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  STUDY CHAIR

Central Study Contacts

Jing Xu, MD

CONTACT

0086-0571-87783521; jing_xu@zju.edu.cn

Qichun Wei, PHD

CONTACT

0086-0571-87783521; qichun_wei@zju.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2024
• First Posted: April 26, 2024
• Study Start: May 1, 2024
• Primary Completion: January 31, 2026
• Study Completion (Estimated): January 31, 2029
• Last Updated: April 26, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)