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Recruiting Not applicable

Timing to Minimally Invasive Surgery After Neoadjuvant Chemoradiotherapy for Rectal Cancer

NCT03465982 · tracked via the Priya Life Science Italy tracker
Phase
Not applicable
Started
2018-06-05
Last updated
2024-04-16

Condition(s) studied

Rectal Cancer

Investigational drug(s) / intervention(s)

Surgery after 8 weeks from chemoradiation treatmentSurgery after 12 weeks from chemoradiation treatment

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

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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) Exclusion Criteria: * Metastatic disease * Squamous carcinoma of the anal canal * 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 * Pregnancy * Unable to complete neoadjuvant treatment * Unable to give free informed consent * Previous radiation treatment on the pelvis * Inflammatory bowel disease * Hereditary colorectal disease * Previous tumors other than non-melanoma skin cancer, papillary or follicular thyroid cancer * Participation in another rectal cancer clinical trial relating to the topic of this trial

Primary outcome measure(s)

  • pathologic complete response (pCR) — 8-12 weeks
    Pathologic Complete response on cancer defined as absence of cancer cells on specimen

Trial sites (14)

FacilityCityRegionStatus
SS. Antonio e Biagio e Cesare Arrigo Hospital Alessandria AL Recruiting
Ospedale Gian Battista Morgagni - Luigi Pierantoni Forlì Forlì-Cesena Recruiting
Ospedale Civile Pietro Cosma Camposampiero Padua Recruiting
Ospedale Sacro Cuore Negrar Verona Recruiting
Ente Ecclesiastico ospedale generale Regionale Miulli Acquaviva delle Fonti Italy Suspended
Ospedale degli Infermi Biella Italy Recruiting
Istituto del Radio Olindo Alberti, Spedali Civili di Brescia Brescia Italy Recruiting
ASST Ospedale di Cremona Cremona Italy Recruiting
Azienda Ospedaliera Universitaria Careggi Florence Italy Recruiting
Ospedale Maggiore Policlinico Fondazione Ca' Granda Milan Italy Recruiting
Ospedale San Raffaele IRCCS Milan Italy Recruiting
Istituto Nazionale Tumori - IRCCS Fondazione G. Pascale Naples Italy Recruiting
Ospedale San Francesco Nuoro Italy Terminated
Azienda Ospedaliera San Giovanni - Addolorata Roma Italy Suspended
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03465982 on ClinicalTrials.gov ↗ ← All trials in Italy