RecruitingPhase 3NCT06940947

Endoscopic Therapy Or Surgery for Early Colon Cancer

Endoscopic THerapy Or Surgery for Early Colon Cancer (ETHOS)

Sponsor

Norwegian Department of Health and Social Affairs

Enrollment

434 participants

Start Date

Aug 25, 2025

Study Type

INTERVENTIONAL

Conditions

Colon Cancer

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

Inclusion Criteria13

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