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Recruiting

NCT Number: NCT06940947

Endoscopic Therapy Or Surgery for Early Colon Cancer

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.

Recruiting

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Key information

Conditions

Colon Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Medical University of Gdańsk

Gdansk, Poland

Location status: Recruiting

Location contact

Piotr Spychalski, MD PhD

CONTACT

[email protected]

90132480

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

eFTR

Procedure

endoscopic full thickness resection

Surgery

Procedure

standard-of-care surgery

Primary outcomes

  1. Rate of severe adverse events, re-admissions and deaths within 30 days

    Time frame: 30 days

    co-primary short-term endpoint is the composite rate of rate of severe adverse events, re-admissions and deaths within 30 days following assigned treatment

  2. Rate of cancer recurrence or CRC death after three years

    Time frame: 3 years

    primary long-term endpoint of CRC death or cancer recurrence or sign of lymph nodes or distant metastases after three years

Study contacts

Contact information is provided by the study sponsor or research team.

MICHAEL BRETTHAUER, MD PhD

CONTACT

[email protected]

+4790132480

Sponsors and collaborators

Lead sponsor

Norwegian Department of Health and Social Affairs

Other Gov

Collaborators

  • Frontier Science Foundation
  • Haukeland University Hospital
  • Helse Stavanger HF
  • Hospital Clinic of Barcelona
  • Institute of Oncology in Warsaw
  • Karolinska Institutet
  • Leuven University Medical Center
  • Medical University of Gdansk
  • Northern Norway Regional Health Trust
  • Sorlandet Hospital HF
  • St. Olavs Hospital
  • University Hospital, Akershus
  • University Hospital, Ghent
  • University Hospital, Limoges
  • University of Oslo
  • University of Roma La Sapienza
  • Universitätsklinikum Hamburg-Eppendorf
  • Vestre Viken Hospital Trust

Registry information

Official study title

Endoscopic THerapy Or Surgery for Early Colon Cancer (ETHOS)

Acronym: ETHOS

Important dates

Study start
2025
Primary completion
2033
Study completion
2033
First posted
Apr 23, 2025
Registry last updated
Nov 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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