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Recruiting NCT06940947

Endoscopic Therapy Or Surgery for Early Colon Cancer

Phase III Interventional Colon Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: eFTR, Surgery.
Who it may be relevant to
Registry conditions: Colon Cancer. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Poland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Endoscopic THerapy Or Surgery for Early Colon Cancer (ETHOS)

Overview

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.

Interventions

  • Procedure eFTR
    endoscopic full thickness resection
  • Procedure Surgery
    standard-of-care surgery

Primary outcome measures

  • Rate of severe adverse events, re-admissions and deaths within 30 days [Time frame: 30 days]
  • Rate of cancer recurrence or CRC death after three years [Time frame: 3 years]

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 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Poland · 1 center
  • Medical University of Gdańsk — Gdansk

Identifiers

NCT: NCT06940947 · 840389

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗