RAE Versus MIE in Patients With Esophageal Cancer After Neoadjuvant Therapy - Trial NCT06012214
Access comprehensive clinical trial information for NCT06012214 through Pure Global AI's free database. This phase not specified trial is sponsored by Shanghai Chest Hospital and is currently Not yet recruiting. The study focuses on Surgical Procedure, Unspecified. Target enrollment is 300 participants.
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Study Focus
Sponsor & Location
Shanghai Chest Hospital
Timeline & Enrollment
N/A
Jan 01, 2024
Dec 31, 2028
Primary Outcome
overall survival
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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06012214
Non-Device Trial