Endoscopic Therapy Or Surgery for Early Colon Cancer

NCT ID: NCT06940947

Last Updated: 2025-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

434 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-25

Study Completion Date

2033-09-01

Brief Summary

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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.

Detailed Description

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Conditions

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Colon Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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eFTR

endoscopic full thickness resection

Group Type EXPERIMENTAL

eFTR

Intervention Type PROCEDURE

endoscopic full thickness resection

Surgery

standard-of-care surgery

Group Type ACTIVE_COMPARATOR

Surgery

Intervention Type PROCEDURE

standard-of-care surgery

Interventions

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eFTR

endoscopic full thickness resection

Intervention Type PROCEDURE

Surgery

standard-of-care surgery

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Gdansk

OTHER

Sponsor Role collaborator

Vestre Viken Hospital Trust

OTHER

Sponsor Role collaborator

Medical Biometry and Epidemiology_- Universitätsklinikum Hamburg Eppendorf

UNKNOWN

Sponsor Role collaborator

Institute of Oncology in Warsaw

UNKNOWN

Sponsor Role collaborator

Karolinska Institutet

OTHER

Sponsor Role collaborator

University Hospital, Limoges

OTHER

Sponsor Role collaborator

University Hospital, Akershus

OTHER

Sponsor Role collaborator

University of Roma La Sapienza

OTHER

Sponsor Role collaborator

Hospital Clinic of Barcelona

OTHER

Sponsor Role collaborator

Leuven University Medical Center

UNKNOWN

Sponsor Role collaborator

University Hospital, Ghent

OTHER

Sponsor Role collaborator

Sørlandet Hospital

UNKNOWN

Sponsor Role collaborator

Northern Norway Regional Health Trust

UNKNOWN

Sponsor Role collaborator

Helse Stavanger HF

OTHER_GOV

Sponsor Role collaborator

Haukeland University Hospital

OTHER

Sponsor Role collaborator

St. Olavs Hospital

OTHER

Sponsor Role collaborator

University of Oslo

OTHER

Sponsor Role collaborator

Frontier Science Foundation

UNKNOWN

Sponsor Role collaborator

Norwegian Department of Health and Social Affairs

OTHER_GOV

Sponsor Role lead

Responsible Party

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Michael Bretthauer

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Medical University of Gdańsk

Gdansk, , Poland

Site Status RECRUITING

Countries

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Poland

Central Contacts

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MICHAEL BRETTHAUER, MD PhD

Role: CONTACT

+4790132480

Facility Contacts

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Piotr Spychalski, MD PhD

Role: primary

Other Identifiers

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840389

Identifier Type: -

Identifier Source: org_study_id

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