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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Esophagus Cancer
• Intervention / Treatment: Radiation: chemo-radiation

Detailed Description

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

• Study Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

• Study Contact: Name: Jing Xu, MD; Phone Number: 0086-0571-87783521; Email: jing_xu@zju.edu.cn
• Study Contact Backup: Name: Qichun Wei, PHD; Phone Number: 0086-0571-87783521; Email: qichun_wei@zju.edu.cn

Study Locations

• China
  • Hangzhou, China
    • Not yet recruiting
    • The Second Affiliated Hospital of Zhejiang University, School of Medicine
    • Contact: Jing Xu; Phone Number: 0086-0571-87783521; Email: jing_xu@zju.edu.cn
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • Recruiting
      • The Second Affiliated Hospital of Zhejiang University School of Medicine
      • Contact: Jing Xu, MD; Phone Number: 0086-0571-87783521; Email: jing_xu@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Prophylactic chemoradiotherapy; pT1a -MM and pT1b-SM1 without pathological risk factors	Radiation: chemo-radiation; different Chemo-radiotherapy regimen
Intensive chemoradiotherapy; pT1b-SM2; pT1a -MM and pT1b-SM1 with pathological risk factors	Radiation: chemo-radiation; different Chemo-radiotherapy regimen
Radical chemoradiotherapy; Positive vertical margin or unknown margin	Radiation: chemo-radiation; different Chemo-radiotherapy regimen

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of toxic events	esophageal stenosis, radiation pneumonitis, etc	2026.2

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
3-year overall survival	the time from randomization until death from any cause	2029.1
3-year local-regional recurrence free survival	the time from randomization until local-regional recurrence	2029.1

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Investigators: Study Chair: Jing Xu, MD, Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): January 31, 2026
• Study Completion (Estimated): January 31, 2029

Study Registration Dates

• First Submitted: April 11, 2024
• First Submitted That Met QC Criteria: April 25, 2024
• First Posted (Actual): April 26, 2024

Study Record Updates

• Last Update Posted (Actual): April 26, 2024
• Last Update Submitted That Met QC Criteria: April 25, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: esophagus cancer; radio-chemotherapy; ESD
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Esophageal Neoplasms
• Other Study ID Numbers: ZhejiangU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No