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RECRUITING
NCT03465982
NA

Timing to Minimally Invasive Surgery After Neoadjuvant Chemoradiotherapy for Rectal Cancer

Sponsor: Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria

View on ClinicalTrials.gov

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

PROCEDURE

Surgery after 8 weeks from chemoradiation treatment

Minimally invasive surgery after 8 weeks from chemoradiation treatment

PROCEDURE

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