Treatment Side EffectsSCARNCT06057350
Surgery Versus Endoscopic Resection for Incompletely Removed Early Colon CAnceR
A study testing Tumor removal in people with Treatment Side Effects and Colorectal Cancer, run by Norwegian Department of Health and Social Affairs at 3 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Treatment Side Effects, Colorectal Cancer
- What is being tested?
- Tumor removal
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 304 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 27 Oct 2023to Sep 2033
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 13Show fewer
- 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
Who cannot join
- all who do not fulfill inclusion criteria
Trial locations and contacts
3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 2 countries
Norway2 sites, 2 recruiting
- Recruiting
Vestre Viken Hospital
Oslo, Akershus, 1346
Jens Aksel Nielsen, MD
- Recruiting
Akershus University Hospital
Oslo
Linn Bernklev, MD
Poland1 site, 1 recruiting
- Recruiting
Maria Sklodowska-Curie National Research Institute of Oncology
Warsaw, 02-781
Michal Kaminski, MD PhD
About this study
Official title: Surgery Versus Endoscopic Resection for Incompletely Removed Early Colon CAnceR (SCAR)- a Randomized Controlled Trial
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
- Being tested
- Tumor removal
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tumor removalProcedure or surgery
Removal of incompletely removed early-stage colon cancer
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Tumor removal |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 days
CRC recurrence or sign of lymph nodes or distant metastases
Rate of CRC recurrence or sign of lymph nodes or distant metastases
Measured: 3 years
Secondary outcomes (11)
CRC recurrence or sign of lymph nodes or distant metastases at 1 year after study treatment
CRC recurrence or metastases
Measured: 1 year
CRC recurrence or sign of lymph nodes or distant metastases at 5 years after study treatment
CRC recurrence or metastases
Measured: 5 years
CRC survival and overall survival at 1,3 and 5 years after study treatment
CRC survival and overall survival
Measured: 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
Measured: 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
Measured: 30 days
Length of hospital stay after study treatment
Hospital stay
Measured: 30 days
Hospital readmission rate after discharge within 30 days after study treatment
Hospital readmission
Measured: 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
Measured: 1 day
Duration of the study procedure
Duration of procedure
Measured: 1 day
Environmental footprint of study procedures at 30 days after study treatment
Carbon dioxide emission in kgCo2 per procedure
Measured: 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)
Measured: 30 days, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start27 Oct 2023
- Primary completionSep 2031 (estimated)
- Study completionSep 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment Side EffectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 304 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Norwegian Department of Health and Social Affairs
- Sponsor type
- Other government
- 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
- Responsible party
- Principal investigator, Michael Bretthauer, Norwegian Department of Health and Social Affairs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06057350
- Sponsor's protocol ID
- REK KULMU-B 613856
- Acronym
- SCAR
- Status last verified
- Feb 2024
- First submitted
- 12 Aug 2023
- Last updated
- 16 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgery Versus Endoscopic Resection for Incompletely Removed Early Colon CAnceR (SCAR)- a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06057350
- Acronym / sponsor ID
- SCAR / REK KULMU-B 613856
- Conditions
- Treatment Side Effects, Colorectal Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 304 participants (estimated)
- Lead sponsor
- Norwegian Department of Health and Social AffairsOther government
- 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
- Study start
- 27 Oct 2023 (actual)
- Primary completion
- Sep 2031 (estimated)
- Study completion
- Sep 2033 (estimated)
- First posted
- 28 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgery | Active comparator | Procedure: Tumor removalPatients 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) | Experimental | Procedure: Tumor removalPatients 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (1 listed)
- all who do not fulfill inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tumor removalRemoval of incompletely removed early-stage colon cancer | Procedure or surgery | EFTR (Endoscopic Full-Thickness Resection), Surgery |
Primary outcome
Severe adverse events
Time frame: 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
CRC recurrence or sign of lymph nodes or distant metastases
Time frame: 3 years
Rate of CRC recurrence or sign of lymph nodes or distant metastases
11 secondary outcomes
CRC recurrence or sign of lymph nodes or distant metastases at 1 year after study treatment
Time frame: 1 year
CRC recurrence or sign of lymph nodes or distant metastases at 5 years after study treatment
Time frame: 5 years
CRC survival and overall survival at 1,3 and 5 years after study treatment
Time frame: 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
Time frame: 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
Time frame: 30 days
Length of hospital stay after study treatment
Time frame: 30 days
Hospital readmission rate after discharge within 30 days after study treatment
Time frame: 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
Time frame: 1 day
Duration of the study procedure
Time frame: 1 day
Environmental footprint of study procedures at 30 days after study treatment
Time frame: 30 days
Health related quality of life and functional outcomes after 30 days and one year
Time frame: 30 days, 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tumor removal in people with Treatment Side Effects and Colorectal Cancer, run by Norwegian Department of Health and Social Affairs at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Norway, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nastazja Pilonis, MD PhD (+48787863649, nastazja@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severe adverse events (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2024; AzTrials last refreshed its copy on 7 Nov 2026.