Surgery Versus Endoscopic Resection for Incompletely Removed Early Colon CAnceR

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 dis

Trial Details

NCT ID
NCT06057350
Phase
NA
Sponsor
Norwegian Department of Health and Social Affairs
Status
RECRUITING
Cancer Type
Colorectal Cancer
Interventions
  • Tumor removal
Locations (sample)
  • Oslo, Akershus, Norway
  • Oslo, Norway|59.91273,10.74609
  • Warsaw, Poland|52.22977,21.01178

Key Eligibility Criteria

  • Men and women, age 40 years or older with endoscopic removal (snare or forceps polypectomy; endoscopic mucosal resection (EMR) or endoscopic submuc…
  • No contraindication for colon surgery as deemed by the multidisciplinary tumor board (MTB) at the participating centre
  • Absence of the following histopathological tumor features: poor differentiation, lymphovascular invasion, tumor budding grade B2-B3.
  • No sign of disease beyond stage T1N0M0 on standard-of-care computed tomography imaging of the thorax, abdomen and pelvis41 and clinical evaluation

For full eligibility, visit ClinicalTrials.gov.

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