Surgery Versus Endoscopic Resection for Incompletely Removed Early Colon CAnceR

Not Applicable

Recruiting

• Conditions: Treatment Side Effects; Colorectal Cancer
• Interventions: Procedure: Tumor removal

• Registration Number: NCT06057350
• Lead Sponsor: Norwegian Department of Health and Social Affairs

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-08-12
• Study First Submitted QC: 2023-09-21
• Study First Posted: 2023-09-28
• Study Start: 2023-10-27
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-15
• Last Update Posted: 2024-02-16
• Primary Completion: 2031-09
• Study Completion: 2033-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 304

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

Exclusion Criteria

• all who do not fulfill inclusion criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Surgery	Tumor removal	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.
EFTR (Endoscopic Full-Thickness Resection)	Tumor removal	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.

Primary Outcome Measures

Name	Time	Method
CRC recurrence or sign of lymph nodes or distant metastases	3 years	Rate of CRC recurrence or sign of lymph nodes or distant metastases
Severe adverse events	30 days	Rate of severe adverse events classified as grade III to V according to the Clavien Dindo classification within 30-days after study treatment

Secondary Outcome Measures

Name	Time	Method
CRC recurrence or sign of lymph nodes or distant metastases at 1 year after study treatment	1 year	CRC recurrence or metastases
CRC recurrence or sign of lymph nodes or distant metastases at 5 years after study treatment	5 years	CRC recurrence or metastases
Duration of the study procedure	1 day	Duration of procedure
CRC survival and overall survival at 1,3 and 5 years after study treatment	1, 3, 5 years	CRC survival and overall survival
Length of hospital stay after study treatment	30 days	Hospital stay
Hospital readmission rate after discharge within 30 days after study treatment	30 days	Hospital readmission
Technical success of the trial procedures, defined as completion of eFTR and surgery as planned with endoscopic complete en-bloc scar excision or complete surgical resection	1 day	Technical success
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	Severe adverse events
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	mild and moderate adverse events
Health related quality of life and functional outcomes after 30 days and one year	30 days, 1 year	European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-C30 (0-100 points; higher point scores mean higher QoL)
Environmental footprint of study procedures at 30 days after study treatment	30 days	Carbon dioxide emission in kgCo2 per procedure

Trial Locations

Locations (3)

Vestre Viken Hospital; 🇳🇴 Oslo, Viken, Norway

Akershus University Hospital; 🇳🇴 Oslo, Norway

Maria Sklodowska-Curie National Research Institute of Oncology; 🇵🇱 Warsaw, Poland