Timing to Minimally Invasive Surgery After Neoadjuvant Chemoradiotherapy for Rectal Cancer: a Multicenter Randomised Controlled Trial
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.
• Age \>18 years
• cT3/4N0/+M0 confirmed on CT-scan, MRI (stratification for T3a-b-c-d) 3
• Tumor starting from the distal or medium rectum (even those crossing the peritoneal reflection at distal margin, within 15 cm from the anal margin)
• Histologically-proven adenocarcinoma of the rectum
• Eligible for a resective surgery with TME (low anterior resection, intersphincteric resection, abdominoperineal resection)
• Eligible for resection by minimally-invasive surgery (standard or robotic-assisted laparoscopic procedure, all robotic systems will be accepted)
• Eligible for chemoradiation treatment
• Able to give written informed consent
• Capable of completing required questionnaires at time of consent (provided questionnaires are available in a language spoke fluently by the participant)