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NCT03465982Recruiting

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

Source: ClinicalTrials.gov · Last updated 16 Apr 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
340 (estimated)
First submitted
23 Feb 2018
Start date
5 Jun 2018
Primary completion date
5 Jun 2025
Lead sponsor
Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
NCT number
NCT03465982

What you commit to

  • Study type: Interventional
  • Planned participants: 340
  • From 5 Jun 2018 to the primary completion date, 5 Jun 2025
  • 14 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous radiation treatment on the pelvis
  • Previous tumors other than non-melanoma skin cancer, papillary or follicular thyroid cancer

Other illness

  • Metastatic disease
  • 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
  • Inflammatory bowel disease
  • Hereditary colorectal disease
  • Participation in another rectal cancer clinical trial relating to the topic of this trial

Other

  • Squamous carcinoma of the anal canal
  • Pregnancy
  • Unable to complete neoadjuvant treatment
  • Unable to give free informed consent

Who the study is looking for

  • 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)

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (14)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Ente Ecclesiastico ospedale generale Regionale Miulli
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Acquaviva delle FontiItalySuspended
SS Antonio e Biagio e Cesare Arrigo Hospital
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AlessandriaItalyRecruiting
Ospedale degli Infermi
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BiellaItalyRecruiting
Istituto del Radio Olindo Alberti, Spedali Civili di Brescia
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BresciaItalyRecruiting
Ospedale Civile Pietro Cosma
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CamposampieroItalyRecruiting
ASST Ospedale di Cremona
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CremonaItalyRecruiting
Azienda Ospedaliera Universitaria Careggi
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FlorenceItalyRecruiting
Ospedale Gian Battista Morgagni - Luigi Pierantoni
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ForlìItalyRecruiting
Ospedale San Raffaele, IRCCS
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MilanItalyRecruiting
Ospedale Maggiore Policlinico Fondazione Ca' Granda
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MilanItalyRecruiting
Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale"
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NaplesItalyRecruiting
Ospedale Sacro Cuore
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NegrarItalyRecruiting
Ospedale San Francesco
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NuoroItalyTerminated
Azienda Ospedaliera San Giovanni Addolorata
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RomaItalySuspended

This page is information, not medical advice. Discuss any trial with your doctor.