Surgery Versus Endoscopic Resection for Incompletely Removed Early Colon CAnceR

NCT ID: NCT06057350

Last Updated: 2024-02-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 304 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-27
• Study Completion Date: 2033-09-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Surgery

Patients randomized to surgery are treated according to current guidelines with either open, laparoscopic or robotic surgical segmental bowel resection corresponding to lymphovascular drainage of the cancer.

Group Type: ACTIVE_COMPARATOR

Tumor removal

Intervention Type: PROCEDURE

Removal of incompletely removed early-stage colon cancer

EFTR (Endoscopic Full-Thickness Resection)

Patients randomised to EFTR are treated using devices approved for eFTR in the European Union and affiliated countries for the indication as applied in the trial. Before EFTR, the scar is identified and documented. The colonoscope is then removed, the EFTR device mounted, the colonoscope re-introduced, and eFTR performed.

Group Type: EXPERIMENTAL

Tumor removal

Intervention Type: PROCEDURE

Removal of incompletely removed early-stage colon cancer

Interventions

Tumor removal

Removal of incompletely removed early-stage colon cancer

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Men and women, age 40 years or older with endoscopic removal (snare or forceps polypectomy; endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) with R1 (resection margin <0.1mm23,40) or Rx resection margins of colon cancer (location proximal to the rectum (12 cm or more from the anal verge))
• No contraindication for colon surgery as deemed by the multidisciplinary tumor board (MTB) at the participating centre
• Absence of the following histopathological tumor features: poor differentiation, lymphovascular invasion, tumor budding grade B2-B3.
• No sign of disease beyond stage T1N0M0 on standard-of-care computed tomography imaging of the thorax, abdomen and pelvis41 and clinical evaluation
• Identifiable resection site with colonoscopy, either by visualizing a previously administered tattoo or by identification of a scar in the correct colon segment
• No other tumors or polyps larger than 10 mm in diameter in the colorectum at time of randomization
• Complete colonoscopy with adequate quality of bowel preparation (Boston Bowel Preparation Scale score ≤2 in all colonic segments) and photo or video documentation of the appendiceal orifice or ileocecal valve.
• No colonic strictures or severe diverticulosis.
• No prior CRC
• No other malignant disease which is not deemed cured
• No confirmed or suspected genetic cancer syndrome (10 or more adenomas/serrated lesions, adenomatous or serrated polyposis syndrome; Lynch or Lynch-like syndrome)
• No inflammatory bowel disease
• Written informed consent provided by before enrolment

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hôpital Edouard Herriot

OTHER

Sponsor Role: collaborator

Maria Sklodowska-Curie National Research Institute of Oncology

OTHER

Sponsor Role: collaborator

Nuovo Regina Margherita Hospital

OTHER

Sponsor Role: collaborator

Karolinska Institutet

OTHER

Sponsor Role: collaborator

Humanitas Clinical and Research Center

OTHER

Sponsor Role: collaborator

Medical University of Gdansk

OTHER

Sponsor Role: collaborator

Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role: collaborator

University Hospital, Akershus

OTHER

Sponsor Role: collaborator

Vestre Viken Hospital Trust

OTHER

Sponsor Role: collaborator

University Hospital of North Norway

OTHER

Sponsor Role: collaborator

Helse Stavanger HF

OTHER_GOV

Sponsor Role: collaborator

Oslo University Hospital

OTHER

Sponsor Role: collaborator

Norwegian Department of Health and Social Affairs

OTHER_GOV

Sponsor Role: lead

Responsible Party

Michael Bretthauer

Co-Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Vestre Viken Hospital

Oslo, Akershus, Norway

Site Status: RECRUITING

Akershus University Hospital

Oslo, , Norway

Site Status: RECRUITING

Maria Sklodowska-Curie National Research Institute of Oncology

Warsaw, , Poland

Site Status: RECRUITING

Countries

Norway; Poland

Central Contacts

Nastazja Pilonis, MD PhD

Role: CONTACT

nastazja@gmail.com

+48787863649

Michael Bretthauer, MD PhD

Role: CONTACT

michael.bretthauer@medisin.uio.no

+4790132480

Facility Contacts

Jens Aksel Nielsen, MD

Role: primary

Linn Bernklev, MD

Role: primary

Michal Kaminski, MD PhD

Role: primary

Other Identifiers

REK KULMU-B 613856

Identifier Type: -

Identifier Source: org_study_id