Endoscopic Therapy Or Surgery for Early Colon Cancer

Recruiting now · Phase 3

Conditions studied: Colon Cancer

In brief

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.

Key facts

Study ID

NCT06940947

Run by

Norwegian Department of Health and Social Affairs

People needed

434

Starts

2025-08-25

Expected to finish

2033-09-01

Last updated by the study team

2025-11-20

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 is running

• Medical University of Gdańsk — Gdansk, Poland (enrolling)

Full record on ClinicalTrials.gov

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