Status:
RECRUITING
Timing to Minimally Invasive Surgery After Neoadjuvant Chemoradiotherapy for Rectal Cancer
Lead Sponsor:
Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
Conditions:
Rectal Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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...
Detailed Description
PURPOSE To demonstrate if delayed timing of surgery after neoadjuvant chemoradiotherapy actually affects pathological complete response (pCR) and reflects on disease-free survival (DFS) and overall s...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 5 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 5 2029
Estimated Enrollment :
340 Patients enrolled
Trial Details
Trial ID
NCT03465982
Start Date
June 5 2018
End Date
June 5 2029
Last Update
April 16 2024
Active Locations (14)
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1
SS. Antonio e Biagio e Cesare Arrigo Hospital
Alessandria, AL, Italy, 15121
2
Ospedale Gian Battista Morgagni - Luigi Pierantoni
Forlì, Forlì-Cesena, Italy
3
Ospedale Civile Pietro Cosma
Camposampiero, Padua, Italy
4
Ospedale Sacro Cuore
Negrar, Verona, Italy