NCT06057350 Surgery Versus Endoscopic Resection for Incompletely Removed Early Colon CAnceR
| NCT ID | NCT06057350 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Norwegian Department of Health and Social Affairs |
| Condition | Treatment Side Effects |
| Study Type | INTERVENTIONAL |
| Enrollment | 304 participants |
| Start Date | 2023-10-27 |
| Primary Completion | 2031-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 304 participants in total. It began in 2023-10-27 with a primary completion date of 2031-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06057350 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, studying Treatment Side Effects. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06057350 currently recruiting?
Yes, NCT06057350 is actively recruiting participants. Contact the research team at nastazja@gmail.com for enrollment information.
Where is the NCT06057350 trial being conducted?
This trial is being conducted at Oslo, Norway, Oslo, Norway, Warsaw, Poland.
Who is sponsoring the NCT06057350 clinical trial?
NCT06057350 is sponsored by Norwegian Department of Health and Social Affairs. The trial plans to enroll 304 participants.