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
Metastatic disease
Squamous carcinoma of the anal canal
Synchronous colorectal tumors requiring multi-segment surgical resection (n.b. a benign lesion within the resection field in addition to the main cancer would not exclude a patient)
History of psychiatric or addictive disorder or other medical condition that, in the opinion of the investigator, would preclude the patient from meeting the trial requirements
Parallel
Surgery after 8 weeks from chemoradiation treatment
Procedure/SurgeryMinimally invasive surgery after 8 weeks from chemoradiation treatment
Surgery after 12 weeks from chemoradiation treatment
Procedure/SurgeryMinimally invasive surgery after 12 weeks from chemoradiation treatment
pathologic complete response (pCR)
Pathologic Complete response on cancer defined as absence of cancer cells on specimen
DFS
Disease Free survival
OS
Overall Survival
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