Timing to Minimally Invasive Surgery After Neoadjuvant Chemoradiotherapy for Rectal Cancer
NCT03465982
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.
Eligibility
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
Conditions2
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NCT03465982