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Endoscopic Therapy Or Surgery for Early Colon Cancer (ETHOS)

N

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

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

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

Trial contacts and locations

0

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Central trial contact

MICHAEL BRETTHAUER, MD PhD

Data sourced from clinicaltrials.gov

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