Endoscopic Therapy Or Surgery for Early Colon Cancer

NCT06940947 | Recruiting Phase 3 DMC

• 1 other identifier: 840389
• Study Type: interventional
• Target: 434
• Locations: 1 country
• Sites: 1

Brief Summary

The trial is a randomized head-to-head comparison of the benefits, harms and burdens of endoscopic full-thickness resection (eFTR), a novel, minimally invasive endoscopic treatment modality, for early colon cancer as compared to standard-of-care surgery.

Conditions

Colon Cancer

Outcome Measures

Primary Outcomes (2)

• Rate of severe adverse events, re-admissions and deaths within 30 days

  co-primary short-term endpoint is the composite rate of rate of severe adverse events, re-admissions and deaths within 30 days following assigned treatment

  30 days

• Rate of cancer recurrence or CRC death after three years

  primary long-term endpoint of CRC death or cancer recurrence or sign of lymph nodes or distant metastases after three years

  3 years

Study Arms (2)

eFTR

EXPERIMENTAL

endoscopic full thickness resection

Procedure: eFTR

Surgery

ACTIVE COMPARATOR

standard-of-care surgery

Procedure: Surgery

Interventions

eFTR PROCEDURE

endoscopic full thickness resection

eFTR

Surgery PROCEDURE

standard-of-care surgery

Surgery

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Newly diagnosed biopsy-confirmed colon cancer (adenocarcinoma) with macroscopic suspicion of submucosal invasion considered removable by EFTR as deemed by the local multidisciplinary team (MDT) at the participating center
• Size ≤20 mm in diameter as deemed by the colonoscopist
• No presence of histopathological high-risk features in biopsy (high grade tumor growth, budding grade 2 or 3, or lymphovascular invasion)
• Patient eligible for surgical removal as deemed by the local MDT at the participating center
• Endoscopic images or video of the tumor
• No sign of disease beyond T2N0M0 on pre-treatment imaging, biopsy sampling, and radiographic and clinical evaluation
• No contraindication for any of the two treatment arms
• Written informed consent
• No prior or synchronous CRC
• No other malignancy which is not cured
• No more than 10 adenomas or serrated polyps
• No genetic cancer syndrome (adenomatous or serrated polyposis syndrome; Lynch or Lynch-like syndrome)
• No inflammatory bowel disease

Sponsors & Collaborators

• Norwegian Department of Health and Social Affairs: lead
• Medical University of Gdansk: collaborator
• Vestre Viken Hospital Trust: collaborator
• Medical Biometry and Epidemiology_- Universitätsklinikum Hamburg Eppendorf: collaborator
• Institute of Oncology in Warsaw: collaborator
• Karolinska Institutet: collaborator
• University Hospital, Limoges: collaborator
• University Hospital, Akershus: collaborator
• University of Roma La Sapienza: collaborator
• Hospital Clinic of Barcelona: collaborator
• Leuven University Medical Center: collaborator
• University Hospital, Ghent: collaborator
• Sørlandet Hospital: collaborator
• Northern Norway Regional Health Trust: collaborator
• Helse Stavanger HF: collaborator
• Haukeland University Hospital: collaborator
• St. Olavs Hospital: collaborator
• University of Oslo: collaborator
• Frontier Science Foundation: collaborator

Study Sites (1)

Medical University of Gdańsk

Gdansk, Poland

RECRUITING

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Central Study Contacts

MICHAEL BRETTHAUER, MD PhD

CONTACT

+4790132480; michael.bretthauer@medisin.uio.no

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 15, 2025
• First Posted: April 23, 2025
• Study Start: August 25, 2025
• Primary Completion (Estimated): September 1, 2033
• Study Completion (Estimated): September 1, 2033
• Last Updated: November 20, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share

Locations

PL (1)