Surgery Versus Endoscopic Resection for Incompletely Removed Early Colon CAnceR

Study Overview
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Brief Summary
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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).

Official Title
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Surgery Versus Endoscopic Resection for Incompletely Removed Early Colon CAnceR (SCAR)- a Randomized Controlled Trial

Conditions
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Treatment Side Effects, Colorectal Cancer

Intervention / Treatment
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* Procedure: Tumor removal


Participation Criteria
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Eligibility Criteria
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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 prior surgical colorectal resection 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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Surgery<br>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<br>* Removal of incompletely removed early-stage colon cancer<br>|
| Experimental: EFTR (Endoscopic Full-Thickness Resection)<br>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<br>* Removal of incompletely removed early-stage colon cancer<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CRC recurrence or sign of lymph nodes or distant metastases at 1 year after study treatment | CRC recurrence or metastases | 1 year | 
| CRC recurrence or sign of lymph nodes or distant metastases at 5 years after study treatment | CRC recurrence or metastases | 5 years | 
| CRC survival and overall survival at 1,3 and 5 years after study treatment | CRC survival and overall survival | 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 | Severe adverse events | 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 | mild and moderate adverse events | 30 days | 
| Length of hospital stay after study treatment | Hospital stay | 30 days | 
| Hospital readmission rate after discharge within 30 days after study treatment | Hospital readmission | 30 days | 
| 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 | Technical success | 1 day | 
| Duration of the study procedure | Duration of procedure | 1 day | 
| Environmental footprint of study procedures at 30 days after study treatment | Carbon dioxide emission in kgCo2 per procedure | 30 days | 
| Health related quality of life and functional outcomes after 30 days and one year | European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-C30 (0-100 points; higher point scores mean higher QoL) | 30 days, 1 year |