New scope procedure may replace surgery for early colon cancer
NCT ID NCT06940947
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study compares a new, less invasive treatment called endoscopic full-thickness resection (eFTR) to standard surgery for early colon cancer. About 434 adults with small, early-stage colon tumors will be randomly assigned to one of the two treatments. The goal is to see if eFTR is as safe and effective as surgery, with fewer side effects and a lower chance of cancer coming back.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 434 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2025
- Expected to finish
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Sep 2033
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a government body.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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Children (under 18), adults (18 to 64) and older adults (65 and over)
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Medical University of Gdańsk
RECRUITINGGdansk, Poland
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