Timing of Surgery After Chemoradiotherapy for Rectal Cancer
Timing to Minimally Invasive Surgery After Neoadjuvant Chemoradiotherapy for Rectal Cancer: a Multicenter Randomised Controlled Trial
This study is testing if having robotic or standard surgery for rectal cancer 8 weeks or 12 weeks after treatment helps patients do better in the long run.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 340 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria Academic / other |
| Drugs / interventions | radiation |
| Locations | 14 sites (Alessandria, AL and 13 other locations) |
| Trial ID | NCT03465982 on ClinicalTrials.gov |
What this trial studies
This trial compares the outcomes of robotic-assisted or standard laparoscopic rectal cancer surgery performed either 8 weeks or 12 weeks after neoadjuvant chemoradiotherapy. It aims to determine if delaying surgery affects the rate of pathological complete response (pCR) and improves disease-free survival (DFS) and overall survival (OS). The study will enroll 332 patients across multiple centers, with a follow-up period extending 5 years after the last patient is randomized. Participants will be randomized after providing consent and completing baseline questionnaires.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with locally advanced rectal cancer eligible for neoadjuvant chemoradiation and minimally invasive surgery.
Not a fit: Patients with metastatic disease or other types of rectal cancer, such as squamous carcinoma, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and survival rates for patients with rectal cancer.
How similar studies have performed: Previous studies have explored timing in surgical interventions for rectal cancer, but this specific comparison of 8 vs. 12 weeks is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Alessandria, AL and 13 other locations
- SS. Antonio e Biagio e Cesare Arrigo Hospital — Alessandria, Al, Italy (Recruiting)
- Ospedale Gian Battista Morgagni - Luigi Pierantoni — Forlì, Forlì-Cesena, Italy (Recruiting)
- Ospedale Civile Pietro Cosma — Camposampiero, Padua, Italy (Recruiting)
- Ospedale Sacro Cuore — Negrar, Verona, Italy (Recruiting)
- Ente Ecclesiastico ospedale generale Regionale Miulli — Acquaviva delle Fonti, Italy (Suspended)
- Ospedale degli Infermi — Biella, Italy (Recruiting)
- Istituto del Radio Olindo Alberti, Spedali Civili di Brescia — Brescia, Italy (Recruiting)
- ASST Ospedale di Cremona — Cremona, Italy (Recruiting)
- Azienda Ospedaliera Universitaria Careggi — Florence, Italy (Recruiting)
- Ospedale Maggiore Policlinico Fondazione Ca' Granda — Milan, Italy (Recruiting)
- Ospedale San Raffaele IRCCS — Milan, Italy (Recruiting)
- Istituto Nazionale Tumori - IRCCS Fondazione G. Pascale — Naples, Italy (Recruiting)
- Ospedale San Francesco — Nuoro, Italy (Terminated)
- Azienda Ospedaliera San Giovanni - Addolorata — Roma, Italy (Suspended)
Study contacts
- Study coordinator: Igor Monsellato, MD
- Email: igor.monsellato@ospedale.al.it
- Phone: +390131206506
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.