Status:
RECRUITING
Surgery Versus Endoscopic Resection for Incompletely Removed Early Colon CAnceR
Lead Sponsor:
Norwegian Department of Health and Social Affairs
Collaborating Sponsors:
Hôpital Edouard Herriot
Maria Sklodowska-Curie National Research Institute of Oncology
Conditions:
Treatment Side Effects
Colorectal Cancer
Eligibility:
All Genders
40+ years
Phase:
NA
Brief Summary
Randomized head-to-head comparison trial among patients who have undergone incomplete endoscopic resection of early colon cancer to evaluate the benefits, harms and burdens, as well as the ecological ...
Eligibility Criteria
Inclusion
- Men and women, age 40 years or older with endoscopic removal (snare or forceps polypectomy; endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) with R1 (resection margin \<0.1mm23,40) or Rx resection margins of colon cancer (location proximal to the rectum (12 cm or more from the anal verge))
- No contraindication for colon surgery as deemed by the multidisciplinary tumor board (MTB) at the participating centre
- Absence of the following histopathological tumor features: poor differentiation, lymphovascular invasion, tumor budding grade B2-B3.
- No sign of disease beyond stage T1N0M0 on standard-of-care computed tomography imaging of the thorax, abdomen and pelvis41 and clinical evaluation
- Identifiable resection site with colonoscopy, either by visualizing a previously administered tattoo or by identification of a scar in the correct colon segment
- No other tumors or polyps larger than 10 mm in diameter in the colorectum at time of randomization
- Complete colonoscopy with adequate quality of bowel preparation (Boston Bowel Preparation Scale score ≤2 in all colonic segments) and photo or video documentation of the appendiceal orifice or ileocecal valve.
- No colonic strictures or severe diverticulosis.
- No prior CRC
- No other malignant disease which is not deemed cured
- No confirmed or suspected genetic cancer syndrome (10 or more adenomas/serrated lesions, adenomatous or serrated polyposis syndrome; Lynch or Lynch-like syndrome)
- No inflammatory bowel disease
- Written informed consent provided by before enrolment
Exclusion
- all who do not fulfill inclusion criteria
Key Trial Info
Start Date :
October 27 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2033
Estimated Enrollment :
304 Patients enrolled
Trial Details
Trial ID
NCT06057350
Start Date
October 27 2023
End Date
September 1 2033
Last Update
February 16 2024
Active Locations (3)
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1
Vestre Viken Hospital
Oslo, Akershus, Norway, 1346
2
Akershus University Hospital
Oslo, Norway
3
Maria Sklodowska-Curie National Research Institute of Oncology
Warsaw, Poland, 02-781