Surgery Versus Endoscopic Resection for Incompletely Removed Early Colon CAnceR
Condition(s) studied
Investigational drug(s) / intervention(s)
Tumor removal: Removal of incompletely removed early-stage colon cancer
Study summary
Randomized head-to-head comparison trial among patients who have undergone incomplete endoscopic resection of early colon cancer to evaluate the benefits, harms and burdens, as well as the ecological footprint and cost-effectiveness of endoscopic full thickness resection (eFTR), a minimally invasive endoscopic treatment with a colonoscope, as compared to standard-of-care surgery.
Co-primary endpoints are
* Rate of severe adverse events classified as grade III to V according to the Clavien Dindo classification within 30-days after study treatment
* CRC recurrence or sign of lymph nodes or distant metastases at 3 years after randomization comparing the two treatment groups (eFTR versus surgery).
Eligibility
Primary outcome measure(s)
- Severe adverse events — 30 days
Rate of severe adverse events classified as grade III to V according to the Clavien Dindo classification within 30-days after study treatment - CRC recurrence or sign of lymph nodes or distant metastases — 3 years
Rate of CRC recurrence or sign of lymph nodes or distant metastases
Trial sites (3)
| Facility | City | Region | Status |
|---|---|---|---|
| Vestre Viken Hospital | Oslo | Akershus | Recruiting |
| Akershus University Hospital | Oslo | Norway | Recruiting |
| Maria Sklodowska-Curie National Research Institute of Oncology | Warsaw | Poland | Recruiting |
More Norwegian Department of Health and Social Affairs trials in Poland
Other trials for the same condition
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 NCT06057350 on ClinicalTrials.gov ↗ ← All trials in Poland