Endoscopic Therapy Or Surgery for Early Colon Cancer

Recruiting Phase 3 Interventional 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.
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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
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About This Trial

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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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…
Contacts

MICHAEL BRETTHAUER, MD PhD

+4790132480

michael.bretthauer@medisin.uio.no

CONTACT