Clinical Trial

TNT of SCRT+CAPOX vs SCRT+CAPOXIRI for Locally Advanced Rectal Cancer

Study acronym: ENSEMBLE
Recruiting Phase 3
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Summary
This trial is a multicenter randomized Phase III study to verify the superiority of short-course preoperative radiation (SCRT) and CAPOXIRI over SCRT and CAPOX as preoperative treatments for locally advanced rectal cancer.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2022-12-09; most recent amendment 2025-03-31.
Trial Details
NCT Number NCT05646511
Lead Sponsor National Cancer Center Hospital East
Collaborators: Japan Agency for Medical Research and Development
Conditions Locally Advanced Rectal Cancer
Enrollment 608 participants
Start Date 2022-11-21
Primary Completion 2029-12-31 (estimated)
Study Completion 2030-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-04-03