Timing to Minimally Invasive Surgery After Neoadjuvant Chemoradiotherapy for Rectal Cancer

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.

Sex

All

Minimum age

18 Years

Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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
* Pregnancy
* Unable to complete neoadjuvant treatment
* Unable to give free informed consent
* Previous radiation treatment on the pelvis
* Inflammatory bowel disease
* Hereditary colorectal disease
* Previous tumors other than non-melanoma skin cancer, papillary or follicular thyroid cancer
* Participation in another rectal cancer clinical trial relating to the topic of this trial

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