Endoscopic Therapy Or Surgery for Early Colon Cancer
Recruiting
Phase 3Interventional Study
Colon Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
434 (estimated)
Sponsor
Norwegian Department of Health and Social Affairs · Government
Who this trial is looking for
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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.
Trial Locations
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City
State
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Status
Eligibility 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 colonoscopis…
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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