Status:
NOT_YET_RECRUITING
RAE Versus MIE in Patients With Esophageal Cancer After Neoadjuvant Therapy
Lead Sponsor:
Shanghai Chest Hospital
Conditions:
Surgical Procedure, Unspecified
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
This is a prospectively randomized controlled trial to compare RAMIE and MIE in the treatment for locally advanced ESCC after neoadjuvant therapy. According to previous studies, long-term survival aft...
Detailed Description
Neoadjuvant therapy followed by radical resection is the recommended treatment for locally advanced esophageal cancer, which could achieve a better R0 resection and overall survival. With the developm...
Eligibility Criteria
Inclusion
- Age ranges from 18 to 75 years;
- European Clinical Oncology Group Performance Status (ECOG PS) 0-2;
- Histological subtype of esophageal squamous cell carcinoma;
- Primary tumors are located at the intrathoracic esophagus;
- Pre-treatment stage as cT1b-4aN1-3M0, cT3N0M0 (AJCC/UICC 8th Edition);
- With neoadjuvant chemoradiotherapy, chemotherapy and immunotherapy;
- Without any anticancer therapy for other malignant diseases;
- Written informed consent.
Exclusion
- Cervical esophageal cancer and carcinoma of gastro-esophageal junction;
- Patients with unresectable or metastatic esophageal cancer;
- Histological subtype of esophageal non-squamous cell carcinoma;
- History of previous thoracic surgery;
- Patients with other malignant tumor (previous or current);
- Participation in another clinical trial during this study.
Key Trial Info
Start Date :
January 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT06012214
Start Date
January 1 2024
End Date
December 31 2028
Last Update
August 25 2023
Active Locations (1)
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1
Shanghai Chest Hospital, Shanghai Jiao Tong University
Shanghai, China, SH 21