Endoscopic full-thickness resection versus surgery for early colon cancer
Official title: Endoscopic THerapy Or Surgery for Early Colon Cancer (ETHOS)
Run by Norwegian Department of Health and Social Affairs · NCT06940947 · Data updated 2026-11-12
This test tries whether a minimally invasive endoscopic full-thickness resection (eFTR) works as well as standard surgery for people with newly diagnosed small (≤20 mm) early colon cancer who have no high-risk biopsy features.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Sex | All |
| Enrollment | 434 (estimated) |
| Sponsor | Norwegian Department of Health and Social Affairs Government |
| Locations | 1 site (Gdansk) |
| Status | Recruiting |
| Started | August 25, 2025 |
| Main results expected | September 1, 2033 |
| Study ends | September 1, 2033 |
| Registry record updated | November 20, 2025 |
| Trial ID | NCT06940947 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults with newly diagnosed biopsy-confirmed colon adenocarcinoma ≤20 mm without high‑risk histologic features, judged removable by eFTR by a local multidisciplinary team and otherwise eligible for surgery.
✕Probably not a fit
Patients with tumors larger than 20 mm, biopsy signs of high‑risk features, evidence of disease beyond T2N0M0, genetic cancer syndromes, prior or synchronous colorectal cancer, or other active uncured malignancies are unlikely to benefit from eFTR in this trial.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a randomized phase 3 head-to-head comparison of endoscopic full-thickness resection (eFTR) versus standard surgical resection for early colon cancer. The trial randomizes eligible patients to either the minimally invasive eFTR procedure or conventional surgery and compares benefits, harms, and patient burden. Eligible tumors are small (≤20 mm) adenocarcinomas without high‑risk histologic features and are selected by a local multidisciplinary team after imaging and biopsy. Participating centers in Europe collect procedural, oncologic, and patient-centered outcome data to compare short- and mid-term results.
Why it matters
Potential benefit: If successful, eFTR could provide similar cancer control with a less invasive procedure, shorter recovery, and fewer surgery-related complications for properly selected patients.
How similar studies have gone: Small case series and feasibility studies have demonstrated that eFTR can remove selected small colon cancers with good short-term outcomes, but randomized phase 3 comparisons with surgery are novel.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Medical University of Gdańsk
Gdansk, Poland Recruiting
Study contacts
- Study coordinator: MICHAEL BRETTHAUER, MD PhD
- Email: michael.bretthauer@medisin.uio.no
- Phone: +4790132480
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.