Status:
RECRUITING
Endoscopic Therapy Or Surgery for Early Colon Cancer
Lead Sponsor:
Norwegian Department of Health and Social Affairs
Collaborating Sponsors:
Medical University of Gdansk
Vestre Viken Hospital Trust
Conditions:
Colon Cancer
Eligibility:
All Genders
Phase:
PHASE3
Brief Summary
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...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Newly diagnosed biopsy-confirmed colon cancer (adenocarcinoma) with macroscopic suspicion of submucosal invasion considered removable by EFTR as deemed by the local multidisciplinary team (MDT) at the participating center
- Size ≤20 mm in diameter as deemed by the colonoscopist
- No presence of histopathological high-risk features in biopsy (high grade tumor growth, budding grade 2 or 3, or lymphovascular invasion)
- Patient eligible for surgical removal as deemed by the local MDT at the participating center
- Endoscopic images or video of the tumor
- No sign of disease beyond T2N0M0 on pre-treatment imaging, biopsy sampling, and radiographic and clinical evaluation
- No contraindication for any of the two treatment arms
- Written informed consent
- No prior or synchronous CRC
- No other malignancy which is not cured
- No more than 10 adenomas or serrated polyps
- No genetic cancer syndrome (adenomatous or serrated polyposis syndrome; Lynch or Lynch-like syndrome)
- No inflammatory bowel disease
Exclusion
Key Trial Info
Start Date :
August 25 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2033
Estimated Enrollment :
434 Patients enrolled
Trial Details
Trial ID
NCT06940947
Start Date
August 25 2025
End Date
September 1 2033
Last Update
November 20 2025
Active Locations (1)
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1
Medical University of Gdańsk
Gdansk, Poland