TiMiSNAR (Timing to Minimally Invasive Surgery after Neoadiuvant chemoRadiotherapy for rectal cancer) is a randomized, parallel-controlled perspective multicentric trial that compares the standard interval vs a delayed interval of 4 weeks after neoadjuvant treatment for surgery in the curative treatment of rectal cancer. 340 patients will be enrolled equally divided into two arms who will undergo surgery after 8 vs 12 weeks after radiochemotherapy treatment. The enrolment interval will be 5 years and the follow-up will end 5 years after the last patient is included in the study.
|wdt_ID||STANDARD INTERVAL TIME||DELAYED INTERVAL TIME|
|1||170 pts||170 pts|
|2||surgery will be performed after 8 weeks (non-extended timing)||surgery will be performed after 12 weeks (extended timing)|
Structure of the study
TiMiSNAR is a NO-profit study organized by SS. Antonio and Biagio and Cesare Arrigo Hospital of Alessandria- Italy (Coordinator Center).
To ensure robust coordination between the various participating centres, the TiMiSNaR study will be organised on aHub-Sitemodel, so that individual participating centres will send their data to the coordinator center. Every single centre is a hub and has its own autonomy. All individual hubs must send the data to the Coordinator Center, which is the primary investigator.
Clinical Pathway of the Trial
- Long course neoadjuvant treatment (chemotherapy – radiotherapy)
- Minimally invasive surgery (standard laparoscopic, robotic and transanal surgery – TaTME)
- Follow up 30 days after surgery
- Follow up at 6 months
- Annual follow-up up to 5 years after surgery
Purpose of the Study
The TiMiSNAR aims to demonstrate whether the longer time interval can affect the complete pathological response and surgical and oncological outcome.