Trials / Recruiting
RecruitingNCT06057350
Surgery Versus Endoscopic Resection for Incompletely Removed Early Colon CAnceR
Surgery Versus Endoscopic Resection for Incompletely Removed Early Colon CAnceR (SCAR)- a Randomized Controlled Trial
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 304 (estimated)
- Sponsor
- Norwegian Department of Health and Social Affairs · Other Government
- Sex
- All
- Age
- 40 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Tumor removal | Removal of incompletely removed early-stage colon cancer |
Timeline
- Start date
- 2023-10-27
- Primary completion
- 2031-09-01
- Completion
- 2033-09-01
- First posted
- 2023-09-28
- Last updated
- 2024-02-16
Locations
3 sites across 2 countries: Norway, Poland
Source: ClinicalTrials.gov record NCT06057350. Inclusion in this directory is not an endorsement.