Surgery Versus Endoscopic Resection for Incompletely Removed Early Colon CAnceR

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

• Treatment Side Effects
• Colorectal Cancer

Interventions

PROCEDURE

Tumor removal

Removal of incompletely removed early-stage colon cancer

Sponsors & Collaborators

• Hôpital Edouard Herriot

  collaborator OTHER

• Maria Sklodowska-Curie National Research Institute of Oncology

  collaborator OTHER

• Nuovo Regina Margherita Hospital

  collaborator OTHER

• Karolinska Institutet

  collaborator OTHER

• Humanitas Clinical and Research Center

  collaborator OTHER

• Medical University of Gdansk

  collaborator OTHER

• Universitätsklinikum Hamburg-Eppendorf

  collaborator OTHER

• University Hospital, Akershus

  collaborator OTHER

• Vestre Viken Hospital Trust

  collaborator OTHER

• University Hospital of North Norway

  collaborator OTHER

• Helse Stavanger HF

  collaborator OTHER_GOV

• Oslo University Hospital

  collaborator OTHER

• Norwegian Department of Health and Social Affairs

  lead OTHER_GOV

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

40 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-10-27

Primary Completion

2031-09-30

Completion

2033-09-30

Countries

• Norway
• Poland

Study Locations