Endoscopic Therapy Or Surgery for Early Colon Cancer (ETHOS)

Norwegian Department of Health and Social Affairs

Status and phase: Not yet enrolling; Phase 3

Conditions: Colon Cancer

Treatments: Procedure: Surgery; Procedure: eFTR

Study type: Interventional

Funder types: Other

Identifiers

NCT06940947

840389

Details and patient eligibility

About

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.

Enrollment: 434 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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434 participants in 2 patient groups

eFTR

Experimental group

Description:

endoscopic full thickness resection

Treatment:

Procedure: eFTR

Surgery

Active Comparator group

Description:

standard-of-care surgery

Treatment:

Procedure: Surgery