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

Esophagus Cancer Clinical Trial

— ESCORT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06385717
• Other study ID #: ZhejiangU
• Status: Recruiting
• Start date: May 1, 2024
• Est. completion date: January 31, 2029

Study information

• Verified date: April 2024
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Jing Xu, MD
• Phone: 0086-0571-87783521
• Email: jing_xu[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: January 31, 2029
• Est. primary completion date: January 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Esophageal Neoplasms
• Esophagus Cancer

Intervention

Radiation:
• chemo-radiation
different Chemo-radiotherapy regimen

Locations

Country	Name	City	State
China	The Second Affiliated Hospital of Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	The Second Affiliated Hospital of Zhejiang University, School of Medicine	Hangzhou

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of toxic events	esophageal stenosis, radiation pneumonitis, etc	2026.2
Secondary	3-year overall survival	the time from randomization until death from any cause	2029.1
Secondary	3-year local-regional recurrence free survival	the time from randomization until local-regional recurrence	2029.1