NCT03465982

Timing to Minimally Invasive Surgery After Neoadjuvant Chemoradiotherapy for Rectal Cancer

Timing to Minimally Invasive Surgery After Neoadjuvant Chemoradiotherapy for Rectal Cancer: a Multicenter Randomised Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 340 (estimated)
• Sponsor: Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PURPOSE To demonstrate if delayed timing of surgery after neoadjuvant chemoradiotherapy actually affects pathological complete response (pCR) and reflects on disease-free survival (DFS) and overall survival (OS) rather than standard timing. Eight weeks are the current standard interval to surgery after neoadjuvant treatment, while 12 weeks represent the "minimum" longer time interval to determine further tumor modifications and the "a priori" choice to avoid hypothetical surgical detrimental effect (postoperative complications related to radiation therapy). Primary Endpoint * pCR Secondary Endpoints * DFS * OS * QoL (quality of Life) Site Eligibility The trial is a multicenter collaboration, involving all those centers able to provide the standard of cure for locally advanced rectal cancer. All the involved centers have to respect the following criteria: * Site able to perform robotic-assisted and standard laparoscopic rectal cancer surgery and TaTME (transanal total mesorectal excision) * Site able to provide a preoperative work up according to the work up criteria specified in this trial * Site able to provide standard neoadjuvant treatment, both chemo and radiation therapy, according to the criteria specified in this trial * Predicted capability to recruit a minimum of 15 patients per year to the trial. Randomization will take place after consent is obtained and after patients have completed their baseline patient reported questionnaires. Patient consent and randomization will take place as close to the date of start of the neoadjuvant treatment as possible and must be no more than 30 days prior to planned treatment.

Conditions

• Rectal Cancer

Interventions

Type	Name	Description
PROCEDURE	Surgery after 8 weeks from chemoradiation treatment	Minimally invasive surgery after 8 weeks from chemoradiation treatment
PROCEDURE	Surgery after 12 weeks from chemoradiation treatment	Minimally invasive surgery after 12 weeks from chemoradiation treatment

Timeline

• Start date: 2018-06-05
• Primary completion: 2025-06-05
• Completion: 2029-06-05
• First posted: 2018-03-15
• Last updated: 2024-04-16

Locations

14 sites across 1 country: Italy