Timing to Minimally Invasive Surgery After Neoadjuvant Chemoradiotherapy for Rectal Cancer
Recruiting · NCT03465982 · Interventional (participants receive a specific treatment) · Lead sponsor: Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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
Where it is running
14 locations listed.
- Ente Ecclesiastico ospedale generale Regionale Miulli - Acquaviva delle Fonti, Italy
- Ospedale degli Infermi - Biella, Italy
- Istituto del Radio Olindo Alberti, Spedali Civili di Brescia - Brescia, Italy
- ASST Ospedale di Cremona - Cremona, Italy
- Azienda Ospedaliera Universitaria Careggi - Florence, Italy
- Ospedale Maggiore Policlinico Fondazione Ca' Granda - Milan, Italy
- Ospedale San Raffaele IRCCS - Milan, Italy
- Istituto Nazionale Tumori - IRCCS Fondazione G. Pascale - Naples, Italy
- Ospedale San Francesco - Nuoro, Italy
- Azienda Ospedaliera San Giovanni - Addolorata - Roma, Italy
- SS. Antonio e Biagio e Cesare Arrigo Hospital - Alessandria, AL, Italy
- Ospedale Gian Battista Morgagni - Luigi Pierantoni - Forlì, Forlì-Cesena, Italy
- Ospedale Civile Pietro Cosma - Camposampiero, Padua, Italy
- Ospedale Sacro Cuore - Negrar, Verona, Italy