Actively Recruiting
Timing to Minimally Invasive Surgery After Neoadjuvant Chemoradiotherapy for Rectal Cancer
Led by Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria · Updated on 2024-04-16
340
Participants Needed
14
Research Sites
574 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Timing to Minimally Invasive Surgery After Neoadjuvant Chemoradiotherapy for Rectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age >18 years
- Clinical stage cT3 or cT4 N0/+ M0 confirmed by CT scan or MRI
- Tumor located in the distal or middle rectum within 15 cm from the anal margin
- Histologically confirmed adenocarcinoma of the rectum
- Eligible for resective surgery with total mesorectal excision (low anterior, intersphincteric, or abdominoperineal resection)
- Eligible for minimally invasive surgery (standard or robotic-assisted laparoscopic procedure)
- Eligible for chemoradiation treatment
- Able to provide written informed consent
- Able to complete required questionnaires in a fluent language at consent time
You will not qualify if you...
- Metastatic disease
- Squamous carcinoma of the anal canal
- Synchronous colorectal tumors requiring multi-segment surgical resection
- History of psychiatric or addictive disorder or other medical conditions precluding trial participation
- Pregnancy
- Unable to complete neoadjuvant treatment
- Unable to provide free informed consent
- Previous pelvic radiation treatment
- Inflammatory bowel disease
- Hereditary colorectal disease
- Previous tumors except non-melanoma skin cancer or certain thyroid cancers
- Participation in another rectal cancer clinical trial related to this topic
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 14 locations
1
SS. Antonio e Biagio e Cesare Arrigo Hospital
Alessandria, AL, Italy, 15121
Actively Recruiting
2
Ospedale Gian Battista Morgagni - Luigi Pierantoni
Forlì, Forlì-Cesena, Italy
Actively Recruiting
3
Ospedale Civile Pietro Cosma
Camposampiero, Padua, Italy
Actively Recruiting
4
Ospedale Sacro Cuore
Negrar, Verona, Italy
Actively Recruiting
5
Ente Ecclesiastico ospedale generale Regionale Miulli
Acquaviva delle Fonti, Italy
Suspended
6
Ospedale degli Infermi
Biella, Italy
Actively Recruiting
7
Istituto del Radio Olindo Alberti, Spedali Civili di Brescia
Brescia, Italy
Actively Recruiting
8
ASST Ospedale di Cremona
Cremona, Italy
Actively Recruiting
9
Azienda Ospedaliera Universitaria Careggi
Florence, Italy
Actively Recruiting
10
Ospedale Maggiore Policlinico Fondazione Ca' Granda
Milan, Italy
Actively Recruiting
11
Ospedale San Raffaele IRCCS
Milan, Italy
Actively Recruiting
12
Istituto Nazionale Tumori - IRCCS Fondazione G. Pascale
Naples, Italy
Actively Recruiting
13
Ospedale San Francesco
Nuoro, Italy
Terminated
14
Azienda Ospedaliera San Giovanni - Addolorata
Roma, Italy
Suspended
Research Team
I
Igor Monsellato, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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