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
Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
340 participants
Jun 5, 2018
INTERVENTIONAL
Conditions
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 Criteria9
- 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 Criteria12
- 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
Interventions
Minimally invasive surgery after 8 weeks from chemoradiation treatment
Minimally invasive surgery after 12 weeks from chemoradiation treatment
Locations(14)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT03465982