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Clinical Trials in Poland / NCT06940947
Recruiting Phase 3

Endoscopic Therapy Or Surgery for Early Colon Cancer

NCT06940947 · tracked via the Priya Life Science Poland tracker
Sponsor
Norwegian Department of Health and Social Affairs
Phase
Phase 3
Started
2025-08-25
Last updated
2025-11-20

Condition(s) studied

Colon Cancer

Investigational drug(s) / intervention(s)

eFTRSurgery

eFTR: endoscopic full thickness resection

Surgery: standard-of-care surgery

Study summary

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.

Eligibility

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Rate of severe adverse events, re-admissions and deaths within 30 days — 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
  • Rate of cancer recurrence or CRC death after three years — 3 years
    primary long-term endpoint of CRC death or cancer recurrence or sign of lymph nodes or distant metastases after three years

Trial sites (1)

FacilityCityRegionStatus
Medical University of Gdańsk Gdansk Poland Recruiting

More Norwegian Department of Health and Social Affairs trials in Poland

Surgery Versus Endoscopic Resection for Incompletely Removed Early Colon CAnceR Recruiting

Other trials for the same condition

Study of Treatment With Intensified Omeprazole Treatment to Prevent High Output Stoma 1 Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06940947 on ClinicalTrials.gov ↗ ← All trials in Poland