Actively Recruiting
Surgery Versus Endoscopic Resection for Incompletely Removed Early Colon CAnceR
Led by Norwegian Department of Health and Social Affairs · Updated on 2024-02-16
304
Participants Needed
3
Research Sites
513 weeks
Total Duration
On this page
Sponsors
N
Norwegian Department of Health and Social Affairs
Lead Sponsor
H
Hôpital Edouard Herriot
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 footprint and cost-effectiveness of endoscopic full thickness resection (eFTR), a minimally invasive endoscopic treatment with a colonoscope, as compared to standard-of-care surgery. Co-primary endpoints are * Rate of severe adverse events classified as grade III to V according to the Clavien Dindo classification within 30-days after study treatment * CRC recurrence or sign of lymph nodes or distant metastases at 3 years after randomization comparing the two treatment groups (eFTR versus surgery).
CONDITIONS
Official Title
Surgery Versus Endoscopic Resection for Incompletely Removed Early Colon CAnceR
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women 40 years or older with incomplete endoscopic removal of early colon cancer in the colon (not rectum)
- No contraindications for colon surgery as confirmed by a tumor board
- No poor tumor features such as poor differentiation, lymphovascular invasion, or high-grade tumor budding
- No disease beyond stage T1N0M0 on CT scans and clinical exam
- Able to identify the removal site with colonoscopy
- No other tumors or polyps larger than 10 mm in the colon at randomization
- Complete colonoscopy with good bowel preparation and documentation
- No colonic strictures or severe diverticulosis
- No prior colorectal cancer
- No other active malignant diseases
- No confirmed or suspected genetic cancer syndromes (including Lynch syndrome and polyposis syndromes)
- No inflammatory bowel disease
- Provided written informed consent
You will not qualify if you...
- Not meeting all inclusion criteria
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Vestre Viken Hospital
Oslo, Akershus, Norway, 1346
Actively Recruiting
2
Akershus University Hospital
Oslo, Norway
Actively Recruiting
3
Maria Sklodowska-Curie National Research Institute of Oncology
Warsaw, Poland, 02-781
Actively Recruiting
Research Team
N
Nastazja Pilonis, MD PhD
CONTACT
M
Michael Bretthauer, MD PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here