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RECRUITING
NCT06057350
NA

Surgery Versus Endoscopic Resection for Incompletely Removed Early Colon CAnceR

Sponsor: Norwegian Department of Health and Social Affairs

View on ClinicalTrials.gov

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).

Official title: Surgery Versus Endoscopic Resection for Incompletely Removed Early Colon CAnceR (SCAR)- a Randomized Controlled Trial

Key Details

Gender

All

Age Range

40 Years - Any

Study Type

INTERVENTIONAL

Enrollment

304

Start Date

2023-10-27

Completion Date

2033-09

Last Updated

2024-02-16

Healthy Volunteers

No

Interventions

PROCEDURE

Tumor removal

Removal of incompletely removed early-stage colon cancer

Locations (3)

Vestre Viken Hospital

Oslo, Akershus, Norway

Akershus University Hospital

Oslo, Norway

Maria Sklodowska-Curie National Research Institute of Oncology

Warsaw, Poland