Synopsis

TIMING TO MINIMALLY INVASIVE SURGERY AFTER NEOADJUVANT CHEMORADIOTHERAPY FOR RECTAL CANCER: A MULTICENTER RANDOMIZED CONTROLLED TRIAL

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.

 

 


 

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

 

    1. Long course neoadjuvant treatment (chemotherapy – radiotherapy)
    2. Minimally invasive surgery (standard laparoscopic, robotic and transanal surgery – TaTME)
    3. Follow up 30 days after surgery
    4. Follow up at 6 months
    5. Annual follow-up up to 5 years after surgery

 


 

Trial algorithm

 

 


 

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.

 

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