Endoscopic full-thickness resection versus surgery for early colon cancer
Endoscopic THerapy Or Surgery for Early Colon Cancer (ETHOS)
PHASE3 · Norwegian Department of Health and Social Affairs · NCT06940947
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 | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 434 (estimated) |
| Sex | All |
| Sponsor | Norwegian Department of Health and Social Affairs (other gov) |
| Locations | 1 site (Gdansk) |
| Trial ID | NCT06940947 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Gdansk
- Medical University of Gdańsk — Gdansk, Poland (RECRUITING)
Study contacts
- Study coordinator: MICHAEL BRETTHAUER, MD PhD
- Email: michael.bretthauer@medisin.uio.no
- Phone: +4790132480
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Colon Cancer