Clinical trial · Interventional
Endoscopic Therapy Or Surgery for Early Colon Cancer
Endoscopic THerapy Or Surgery for Early Colon Cancer (ETHOS)
NCT06940947CI-TRIAL-00097592ETHOSrecruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| eFTR | Procedure | — | UNRESOLVED |
| Surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- eFTR
- description
- endoscopic full thickness resection
- interventionNames
- Procedure: eFTR
- type
- ACTIVE_COMPARATOR
- label
- Surgery
- description
- standard-of-care surgery
- interventionNames
- Procedure: Surgery
Primary outcomes (2)
- measure
- Rate of severe adverse events, re-admissions and deaths within 30 days
- timeFrame
- 30 days
- description
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.