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Surgery Versus Endoscopic Resection for Incompletely Removed Early Colon CAnceR (SCAR)

Primary Purpose

Treatment Side Effects, Colorectal Cancer

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Tumor removal
Sponsored by
Norwegian Department of Health and Social Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Treatment Side Effects

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Surgery

    EFTR (Endoscopic Full-Thickness Resection)

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    CRC recurrence or sign of lymph nodes or distant metastases at 1 year after study treatment
    CRC recurrence or metastases
    CRC recurrence or sign of lymph nodes or distant metastases at 5 years after study treatment
    CRC recurrence or metastases
    CRC survival and overall survival at 1,3 and 5 years after study treatment
    CRC survival and overall survival
    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
    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
    Length of hospital stay after study treatment
    Hospital stay
    Hospital readmission rate after discharge within 30 days after study treatment
    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
    Technical success
    Duration of the study procedure
    Duration of procedure
    Environmental footprint of study procedures at 30 days after study treatment
    Carbon dioxide emission in kgCo2 per procedure
    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)

    Full Information

    First Posted
    August 12, 2023
    Last Updated
    September 21, 2023
    Sponsor
    Norwegian Department of Health and Social Affairs
    Collaborators
    Hôpital Edouard Herriot, Maria Sklodowska-Curie National Research Institute of Oncology, Nuovo Regina Margherita Hospital, Karolinska Institutet, Humanitas Clinical and Research Center, Medical University of Gdansk, Universitätsklinikum Hamburg-Eppendorf, University Hospital, Akershus, Vestre Viken Hospital Trust, University Hospital of North Norway, Helse Stavanger HF, Oslo University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06057350
    Brief Title
    Surgery Versus Endoscopic Resection for Incompletely Removed Early Colon CAnceR
    Acronym
    SCAR
    Official Title
    Surgery Versus Endoscopic Resection for Incompletely Removed Early Colon CAnceR (SCAR)- a Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 2023 (Anticipated)
    Primary Completion Date
    September 2031 (Anticipated)
    Study Completion Date
    September 2033 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Norwegian Department of Health and Social Affairs
    Collaborators
    Hôpital Edouard Herriot, Maria Sklodowska-Curie National Research Institute of Oncology, Nuovo Regina Margherita Hospital, Karolinska Institutet, Humanitas Clinical and Research Center, Medical University of Gdansk, Universitätsklinikum Hamburg-Eppendorf, University Hospital, Akershus, Vestre Viken Hospital Trust, University Hospital of North Norway, Helse Stavanger HF, Oslo University Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Treatment Side Effects, Colorectal Cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    304 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Surgery
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    EFTR (Endoscopic Full-Thickness Resection)
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Procedure
    Intervention Name(s)
    Tumor removal
    Intervention Description
    Removal of incompletely removed early-stage colon cancer
    Primary Outcome Measure Information:
    Title
    Severe adverse events
    Description
    Rate of severe adverse events classified as grade III to V according to the Clavien Dindo classification within 30-days after study treatment
    Time Frame
    30 days
    Title
    CRC recurrence or sign of lymph nodes or distant metastases
    Description
    Rate of CRC recurrence or sign of lymph nodes or distant metastases
    Time Frame
    3 years
    Secondary Outcome Measure Information:
    Title
    CRC recurrence or sign of lymph nodes or distant metastases at 1 year after study treatment
    Description
    CRC recurrence or metastases
    Time Frame
    1 year
    Title
    CRC recurrence or sign of lymph nodes or distant metastases at 5 years after study treatment
    Description
    CRC recurrence or metastases
    Time Frame
    5 years
    Title
    CRC survival and overall survival at 1,3 and 5 years after study treatment
    Description
    CRC survival and overall survival
    Time Frame
    1, 3, 5 years
    Title
    Rate of severe adverse events classified as grade III to V according to the Clavien Dindo classification within 1 year after study treatment
    Description
    Severe adverse events
    Time Frame
    1 year
    Title
    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
    Description
    mild and moderate adverse events
    Time Frame
    30 days
    Title
    Length of hospital stay after study treatment
    Description
    Hospital stay
    Time Frame
    30 days
    Title
    Hospital readmission rate after discharge within 30 days after study treatment
    Description
    Hospital readmission
    Time Frame
    30 days
    Title
    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
    Description
    Technical success
    Time Frame
    1 day
    Title
    Duration of the study procedure
    Description
    Duration of procedure
    Time Frame
    1 day
    Title
    Environmental footprint of study procedures at 30 days after study treatment
    Description
    Carbon dioxide emission in kgCo2 per procedure
    Time Frame
    30 days
    Title
    Health related quality of life and functional outcomes after 30 days and one year
    Description
    European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-C30 (0-100 points; higher point scores mean higher QoL)
    Time Frame
    30 days, 1 year
    Other Pre-specified Outcome Measures:
    Title
    Cost-effectiveness
    Description
    Costs in dollars as compared to effectiveness
    Time Frame
    5 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    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 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Nastazja Pilonis, MD PhD
    Phone
    +48787863649
    Email
    nastazja@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Michael Bretthauer, MD PhD
    Phone
    +4790132480
    Email
    michael.bretthauer@vikenfiber.no

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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