Timing to Minimally Invasive Surgery After Neoadjuvant Chemoradiotherapy for Rectal Cancer
Recruiting now · Not applicable
Conditions studied: Rectal Cancer
In brief
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.
Key facts
- Study ID
- NCT03465982
- Run by
- Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
- People needed
- 340
- Starts
- 2018-06-05
- Expected to finish
- 2029-06-05
- Last updated by the study team
- 2024-04-16
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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
- Ospedale Civile Pietro Cosma — Camposampiero, Padua, Italy (enrolling)
- SS. Antonio e Biagio e Cesare Arrigo Hospital — Alessandria, AL, Italy (enrolling)
- Ospedale Gian Battista Morgagni - Luigi Pierantoni — Forlì, Forlì-Cesena, Italy (enrolling)
- Ospedale Sacro Cuore — Negrar, Verona, Italy (enrolling)
- Ospedale degli Infermi — Biella, Italy (enrolling)
- Istituto del Radio Olindo Alberti, Spedali Civili di Brescia — Brescia, Italy (enrolling)
- ASST Ospedale di Cremona — Cremona, Italy (enrolling)
- Azienda Ospedaliera Universitaria Careggi — Florence, Italy (enrolling)
- Ospedale Maggiore Policlinico Fondazione Ca' Granda — Milan, Italy (enrolling)
- Ospedale San Raffaele IRCCS — Milan, Italy (enrolling)
- Istituto Nazionale Tumori - IRCCS Fondazione G. Pascale — Naples, Italy (enrolling)
- Ente Ecclesiastico ospedale generale Regionale Miulli — Acquaviva delle Fonti, Italy
- Azienda Ospedaliera San Giovanni - Addolorata — Roma, Italy
- Ospedale San Francesco — Nuoro, Italy
Full record on ClinicalTrials.gov
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