Clinical Trial

Timing to Minimally Invasive Surgery After Neoadjuvant Chemoradiotherapy for Rectal Cancer

Study acronym: TiMiSNAR
Recruiting
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Record status
This record was last updated April 16, 2024 (before its estimated June 5, 2025 completion). Its status may not reflect the trial's current state.
Summary
The trial is a multicenter, prospective, randomized controlled, unblinded, parallel-group trial comparing standard and delayed surgery after neoadjuvant chemoradiotherapy for the curative treatment of rectal cancer. Three-hundred and thirty-two patients will be randomized on an equal basis to either robotic-assisted/standard laparoscopic rectal cancer surgery after 8 weeks or robotic-assisted/standard laparoscopic rectal cancer surgery after 12 weeks. The recruiting interval will be of 5 years and the follow-up period will end 5 years after the last patient is randomized.
Protocol Amendment History 20 amendments
This ClinicalTrials.gov record has been amended 20 times since 2018-03-08; most recent amendment 2024-04-15.
Status change: Not Yet Recruiting → Recruiting 2018-06-06
Trial Details
NCT Number NCT03465982
Lead Sponsor Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
Conditions Rectal Cancer
Enrollment 340 participants
Start Date 2018-06-05
Primary Completion 2025-06-05 (estimated)
Study Completion 2029-06-05 (estimated)
Updated on ClinicalTrials.gov 2024-04-16