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
- Diseases
- Colorectal cancer
- 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
Sites (14)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ente Ecclesiastico ospedale generale Regionale Miulli Coordinator of this site? Confirm its status | Acquaviva delle Fonti | Italy | Suspended |
| SS Antonio e Biagio e Cesare Arrigo Hospital Coordinator of this site? Confirm its status | Alessandria | Italy | Recruiting |
| Ospedale degli Infermi Coordinator of this site? Confirm its status | Biella | Italy | Recruiting |
| Istituto del Radio Olindo Alberti, Spedali Civili di Brescia Coordinator of this site? Confirm its status | Brescia | Italy | Recruiting |
| Ospedale Civile Pietro Cosma Coordinator of this site? Confirm its status | Camposampiero | Italy | Recruiting |
| ASST Ospedale di Cremona Coordinator of this site? Confirm its status | Cremona | Italy | Recruiting |
| Azienda Ospedaliera Universitaria Careggi Coordinator of this site? Confirm its status | Florence | Italy | Recruiting |
| Ospedale Gian Battista Morgagni - Luigi Pierantoni Coordinator of this site? Confirm its status | Forlì | Italy | Recruiting |
| Ospedale San Raffaele, IRCCS Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Ospedale Maggiore Policlinico Fondazione Ca' Granda Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale" Coordinator of this site? Confirm its status | Naples | Italy | Recruiting |
| Ospedale Sacro Cuore Coordinator of this site? Confirm its status | Negrar | Italy | Recruiting |
| Ospedale San Francesco Coordinator of this site? Confirm its status | Nuoro | Italy | Terminated |
| Azienda Ospedaliera San Giovanni Addolorata Coordinator of this site? Confirm its status | Roma | Italy | Suspended |
This page is information, not medical advice. Discuss any trial with your doctor.