NCT06940947 Endoscopic Therapy Or Surgery for Early Colon Cancer
| NCT ID | NCT06940947 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Norwegian Department of Health and Social Affairs |
| Condition | Colon Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 434 participants |
| Start Date | 2025-08-25 |
| Primary Completion | 2033-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 434 participants in total. It began in 2025-08-25 with a primary completion date of 2033-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 colon cancer as compared to standard-of-care surgery.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06940947 clinical trial?
This trial is open to participants of all sexes, studying Colon Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06940947 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 434 participants.
Is NCT06940947 currently recruiting?
Yes, NCT06940947 is actively recruiting participants. Contact the research team at michael.bretthauer@medisin.uio.no for enrollment information.
Where is the NCT06940947 trial being conducted?
This trial is being conducted at Gdansk, Poland.
Who is sponsoring the NCT06940947 clinical trial?
NCT06940947 is sponsored by Norwegian Department of Health and Social Affairs. The trial plans to enroll 434 participants.
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