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Timing to Minimally Invasive Surgery After Neoadjuvant Chemoradiotherapy for Rectal Cancer
Sponsor: Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
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.
Official title: Timing to Minimally Invasive Surgery After Neoadjuvant Chemoradiotherapy for Rectal Cancer: a Multicenter Randomised Controlled Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
340
Start Date
2018-06-05
Completion Date
2029-06-05
Last Updated
2024-04-16
Healthy Volunteers
No
Conditions
Interventions
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
Locations (14)
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
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