NCT06057350

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).

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
304

participants targeted

Target at P75+ for not_applicable

Timeline
89mo left

Started Oct 2023

Longer than P75 for not_applicable

Geographic Reach
2 countries

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress26%
Oct 2023Sep 2033

First Submitted

Initial submission to the registry

August 12, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 28, 2023

Completed
29 days until next milestone

Study Start

First participant enrolled

October 27, 2023

Completed
7.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2031

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2033

Last Updated

February 16, 2024

Status Verified

February 1, 2024

Enrollment Period

7.9 years

First QC Date

August 12, 2023

Last Update Submit

February 15, 2024

Conditions

Treatment Side EffectsColorectal Cancer

Outcome Measures

Primary Outcomes (2)

  • Severe adverse events

    Rate of severe adverse events classified as grade III to V according to the Clavien Dindo classification within 30-days after study treatment

    30 days

  • CRC recurrence or sign of lymph nodes or distant metastases

    Rate of CRC recurrence or sign of lymph nodes or distant metastases

    3 years

Secondary Outcomes (11)

  • CRC recurrence or sign of lymph nodes or distant metastases at 1 year after study treatment

    1 year

  • CRC recurrence or sign of lymph nodes or distant metastases at 5 years after study treatment

    5 years

  • CRC survival and overall survival at 1,3 and 5 years after study treatment

    1, 3, 5 years

  • Rate of severe adverse events classified as grade III to V according to the Clavien Dindo classification within 1 year after study treatment

    1 year

  • Rate of mild and moderate adverse events classified as grade I and II according to the Clavien Dindo classification at 30 days after study treatment

    30 days

  • +6 more secondary outcomes

Other Outcomes (1)

  • Cost-effectiveness

    5 years

Study Arms (2)

Surgery

ACTIVE COMPARATOR

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.

Procedure: Tumor removal

EFTR (Endoscopic Full-Thickness Resection)

EXPERIMENTAL

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.

Procedure: Tumor removal

Interventions

Tumor removalPROCEDURE

Removal of incompletely removed early-stage colon cancer

EFTR (Endoscopic Full-Thickness Resection)Surgery

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Vestre Viken Hospital

Oslo, Akershus, 1346, Norway

RECRUITING

Akershus University Hospital

Oslo, Norway

RECRUITING

Maria Sklodowska-Curie National Research Institute of Oncology

Warsaw, 02-781, Poland

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Central Study Contacts

Nastazja Pilonis, MD PhD

CONTACT

+48787863649nastazja@gmail.com

Michael Bretthauer, MD PhD

CONTACT

+4790132480michael.bretthauer@medisin.uio.no

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Co-Principal Investigator

Study Record Dates

First Submitted

August 12, 2023

First Posted

September 28, 2023

Study Start

October 27, 2023

Primary Completion (Estimated)

September 1, 2031

Study Completion (Estimated)

September 1, 2033

Last Updated

February 16, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

NO(2)PL(1)