Actively Recruiting
Endoscopic Therapy Or Surgery for Early Colon Cancer
Led by Norwegian Department of Health and Social Affairs · Updated on 2025-11-20
434
Participants Needed
1
Research Sites
418 weeks
Total Duration
On this page
Sponsors
N
Norwegian Department of Health and Social Affairs
Lead Sponsor
M
Medical University of Gdansk
Collaborating Sponsor
AI-Summary
What this Trial Is About
The trial is a randomized head-to-head comparison of the benefits, harms and burdens of endoscopic full-thickness resection (eFTR), a novel, minimally invasive endoscopic treatment modality, for early colon cancer as compared to standard-of-care surgery.
CONDITIONS
Official Title
Endoscopic Therapy Or Surgery for Early Colon Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Newly diagnosed biopsy-confirmed colon cancer (adenocarcinoma) with suspicion of submucosal invasion removable by eFTR as judged by local team
- Tumor size 20 mm or less in diameter
- No high-risk features in biopsy such as high grade tumor growth, budding grade 2 or 3, or lymphovascular invasion
- Patient eligible for surgical removal as judged by local team
- Endoscopic images or video of the tumor available
- No sign of disease beyond T2N0M0 stage on imaging, biopsy, and clinical evaluation
- No contraindications for either treatment arm
- Written informed consent provided
- No prior or simultaneous colorectal cancer
- No other uncured malignancy
- No more than 10 adenomas or serrated polyps
- No genetic cancer syndromes such as adenomatous or serrated polyposis syndrome or Lynch syndrome
- No inflammatory bowel disease
You will not qualify if you...
- Presence of histopathological high-risk features in biopsy (high grade tumor growth, budding grade 2 or 3, or lymphovascular invasion)
- Disease stage beyond T2N0M0
- Contraindications for either treatment arm
- Prior or synchronous colorectal cancer
- Other uncured malignancies
- More than 10 adenomas or serrated polyps
- Genetic cancer syndromes (adenomatous or serrated polyposis syndrome; Lynch or Lynch-like syndrome)
- Inflammatory bowel disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Medical University of Gdańsk
Gdansk, Poland
Actively Recruiting
Research Team
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