RecruitingNot ApplicableNCT03465982

Timing to Minimally Invasive Surgery After Neoadjuvant Chemoradiotherapy for Rectal Cancer

Timing to Minimally Invasive Surgery After Neoadjuvant Chemoradiotherapy for Rectal Cancer: a Multicenter Randomised Controlled Trial


Sponsor

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

Enrollment

340 participants

Start Date

Jun 5, 2018

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This international study is comparing two different timing strategies for surgery in rectal cancer patients who have finished their pre-surgery chemotherapy and radiation treatment: waiting the standard 7–8 weeks versus waiting longer (11–12 weeks), to see which gives the best chance of the tumor shrinking completely before removal. **You may be eligible if...** - You are over 18 years old - You have been diagnosed with rectal cancer (adenocarcinoma) confirmed by biopsy - Your cancer is located in the lower or middle part of the rectum (within 15 cm of the anal opening) - Your cancer has not spread to distant organs (no metastases) - You are eligible for minimally invasive (laparoscopic or robotic) surgery - You are eligible for pre-surgery chemotherapy and radiation treatment **You may NOT be eligible if...** - Your cancer has spread to other organs - You have anal canal squamous carcinoma (a different type of cancer) - You have inflammatory bowel disease or hereditary colorectal cancer - You are pregnant - You have previously had pelvic radiation - You have participated in another rectal cancer trial on the same topic Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURESurgery after 8 weeks from chemoradiation treatment

Minimally invasive surgery after 8 weeks from chemoradiation treatment

PROCEDURESurgery 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

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NCT03465982


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