Ireland
--:--IST
Recruiting Not applicable

Surgery Versus Endoscopic Resection for Incompletely Removed Early Colon CAnceR

NCT06057350 · tracked via the Priya Life Science Poland tracker
Sponsor
Norwegian Department of Health and Social Affairs
Phase
Not applicable
Started
2023-10-27
Last updated
2024-02-16

Condition(s) studied

Treatment Side EffectsColorectal Cancer

Investigational drug(s) / intervention(s)

Tumor removal

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

Sex
ALL
Min age
40 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Men and women, age 40 years or older with endoscopic removal (snare or forceps polypectomy; endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) with R1 (resection margin \<0.1mm23,40) or Rx resection margins of colon cancer (location proximal to the rectum (12 cm or more from the anal verge)) * 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 * Identifiable resection site with colonoscopy, either by visualizing a previously administered tattoo or by identification of a scar in the correct colon segment * No other tumors or polyps larger than 10 mm in diameter in the colorectum at time of randomization * Complete colonoscopy with adequate quality of bowel preparation (Boston Bowel Preparation Scale score ≤2 in all colonic segments) and photo or video documentation of the appendiceal orifice or ileocecal valve. * No colonic strictures or severe diverticulosis. * No prior CRC * No other malignant disease which is not deemed cured * No confirmed or suspected genetic cancer syndrome (10 or more adenomas/serrated lesions, adenomatous or serrated polyposis syndrome; Lynch or Lynch-like syndrome) * No inflammatory bowel disease * Written informed consent provided by before enrolment Exclusion Criteria: * all who do not fulfill inclusion criteria

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)

FacilityCityRegionStatus
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

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 NCT06057350 on ClinicalTrials.gov ↗ ← All trials in Poland