RAE Versus MIE in Patients With Esophageal Cancer After Neoadjuvant Therapy

NCT06012214 · tracked via the Priya Life Science China tracker

Sponsor

Shanghai Chest Hospital

Phase

Not applicable

Started

2024-01-01

Last updated

2023-08-25

Condition(s) studied

Surgical Procedure, Unspecified

Investigational drug(s) / intervention(s)

ROBOTIC-ASSISTED ESOPHAGECTOMY

ROBOTIC-ASSISTED ESOPHAGECTOMY: Comparison between robotic and conventional minimally invasive esophagectomy

Study 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 after RAMIE seemed to be at least comparable to MIE or open esophagectomy. Therefore, the RAMIE-2 study was designed as a non-inferiority trial, which was based on the hypothesis that the 5-year overall survival of patients who received RAMIE is uncompromised to MIE. To achieve the primary endpoint, 260 cases will be recruited in our hospital. Based on the volume of esophagectomy (1000 cases/year) and the proportion of patients with neoadjuvant therapy (50%) in our institution, approximately 10 patients will be enrolled for each group per month for this trial. The study will be performed in accordance with the principles of the Declaration of Helsinki and Good Clinical Practice Guidelines. Written informed consent will be obtained from each participant. The flow chart of this trial is also presented.

Eligibility

Sex

ALL

Min age

18 Years

Max age

75 Years

Healthy volunteers

Inclusion Criteria: 1. Age ranges from 18 to 75 years; 2. European Clinical Oncology Group Performance Status (ECOG PS) 0-2; 3. Histological subtype of esophageal squamous cell carcinoma; 4. Primary tumors are located at the intrathoracic esophagus; 5. Pre-treatment stage as cT1b-4aN1-3M0, cT3N0M0 (AJCC/UICC 8th Edition); 6. With neoadjuvant chemoradiotherapy, chemotherapy and immunotherapy; 7. Without any anticancer therapy for other malignant diseases; 8. Written informed consent. Exclusion Criteria: 1. Cervical esophageal cancer and carcinoma of gastro-esophageal junction; 2. Patients with unresectable or metastatic esophageal cancer; 3. Histological subtype of esophageal non-squamous cell carcinoma; 4. History of previous thoracic surgery; 5. Patients with other malignant tumor (previous or current); 6. Participation in another clinical trial during this study.

Primary outcome measure(s)

overall survival — up to 5 years
defined as the time from the date of surgery to the day of death or to the last follow-up.

Trial sites (1)

Facility	City	Region	Status
Shanghai Chest Hospital, Shanghai Jiao Tong University	Shanghai	China

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06012214 on ClinicalTrials.gov ↗ ← All trials in China