Timing to Minimally Invasive Surgery After Neoadjuvant Chemoradiotherapy for Rectal Cancer
Condition(s) studied
Investigational drug(s) / intervention(s)
Surgery after 8 weeks from chemoradiation treatment: Minimally invasive surgery after 8 weeks from chemoradiation treatment
Surgery after 12 weeks from chemoradiation treatment: Minimally invasive surgery after 12 weeks from chemoradiation treatment
Study 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
Primary outcome measure(s)
- pathologic complete response (pCR) — 8-12 weeks
Pathologic Complete response on cancer defined as absence of cancer cells on specimen
Trial sites (14)
| Facility | City | Region | Status |
|---|---|---|---|
| SS. Antonio e Biagio e Cesare Arrigo Hospital | Alessandria | AL | Recruiting |
| Ospedale Gian Battista Morgagni - Luigi Pierantoni | Forlì | Forlì-Cesena | Recruiting |
| Ospedale Civile Pietro Cosma | Camposampiero | Padua | Recruiting |
| Ospedale Sacro Cuore | Negrar | Verona | 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 |
More Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria trials in Italy
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT03465982 on ClinicalTrials.gov ↗ ← All trials in Italy