Colon CancerPhase 3ETHOSNCT06940947
Endoscopic Therapy Or Surgery for Early Colon Cancer
A Phase 3 study testing eFTR and Surgery in people with Colon Cancer, run by Norwegian Department of Health and Social Affairs at 1 site in Poland.
Trial summary
The trial is a randomized head-to-head comparison of the benefits, harms and burdens of endoscopic full-thickness resection (eFTR), a novel, minimally invasive endoscopic treatment modality, for early colon cancer as compared to standard-of-care surgery. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Colon Cancer
- What is being tested?
- eFTR and Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 434 participants
- Where
- 1 sitePoland
- Study dates
- 25 Aug 2025to 1 Sep 2033
- Phase
- Phase 3
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Newly diagnosed biopsy-confirmed colon cancer (adenocarcinoma) with macroscopic suspicion of submucosal invasion considered removable by EFTR as deemed by the local multidisciplinary team (MDT) at the participating center
- Size ≤20 mm in diameter as deemed by the colonoscopist
- No presence of histopathological high-risk features in biopsy (high grade tumor growth, budding grade 2 or 3, or lymphovascular invasion)
- Patient eligible for surgical removal as deemed by the local MDT at the participating center
- Endoscopic images or video of the tumor
- No sign of disease beyond T2N0M0 on pre-treatment imaging, biopsy sampling, and radiographic and clinical evaluation
Show all 13Show fewer
- No contraindication for any of the two treatment arms
- Written informed consent
- No prior or synchronous CRC
- No other malignancy which is not cured
- No more than 10 adenomas or serrated polyps
- No genetic cancer syndrome (adenomatous or serrated polyposis syndrome; Lynch or Lynch-like syndrome)
- No inflammatory bowel disease
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
Medical University of Gdańsk
Gdansk
Piotr Spychalski, MD PhD, 90132480, piotr.spychalski@gmail.com
About this study
Official title: Endoscopic THerapy Or Surgery for Early Colon Cancer (ETHOS)
The trial is a randomized head-to-head comparison of the benefits, harms and burdens of endoscopic full-thickness resection (eFTR), a novel, minimally invasive endoscopic treatment modality, for early colon cancer as compared to standard-of-care surgery.
- Conditions
- Colon Cancer
- Being tested
- eFTR, Surgery
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eFTRProcedure or surgery
endoscopic full thickness resection
SurgeryProcedure or surgery
standard-of-care surgery
| Study group | Role | What they receive |
|---|---|---|
| eFTR | Experimental | endoscopic full thickness resection Receives: Procedure: eFTR |
| Surgery | Active comparator | standard-of-care surgery Receives: Procedure: Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of severe adverse events, re-admissions and deaths within 30 days
co-primary short-term endpoint is the composite rate of rate of severe adverse events, re-admissions and deaths within 30 days following assigned treatment
Measured: 30 days
Rate of cancer recurrence or CRC death after three years
primary long-term endpoint of CRC death or cancer recurrence or sign of lymph nodes or distant metastases after three years
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2025
- Study start25 Aug 2025
- Primary completion1 Sep 2033 (estimated)
- Study completion1 Sep 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon CancerStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 434 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Norwegian Department of Health and Social Affairs
- Sponsor type
- Other government
- Collaborators
- Medical University of Gdansk, Vestre Viken Hospital Trust, Universitätsklinikum Hamburg-Eppendorf, Institute of Oncology in Warsaw, Karolinska Institutet, University Hospital, Limoges, University Hospital, Akershus, University of Roma La Sapienza, Hospital Clinic of Barcelona, Leuven University Medical Center, University Hospital, Ghent, Sorlandet Hospital HF, Northern Norway Regional Health Trust, Helse Stavanger HF, Haukeland University Hospital, St. Olavs Hospital, University of Oslo, Frontier Science Foundation
- Responsible party
- Principal investigator, Michael Bretthauer, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06940947
- Sponsor's protocol ID
- 840389
- Acronym
- ETHOS
- Status last verified
- Nov 2025
- First submitted
- 15 Apr 2025
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Only if ethical approval is granted by the other researchers, and the study scientific board has reviewed and approved the proposal
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic THerapy Or Surgery for Early Colon Cancer (ETHOS)
- ClinicalTrials.gov ID
- NCT06940947
- Acronym / sponsor ID
- ETHOS / 840389
- Conditions
- Colon Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 434 participants (estimated)
- Lead sponsor
- Norwegian Department of Health and Social AffairsOther government
- Collaborators
- Medical University of Gdansk, Vestre Viken Hospital Trust, Universitätsklinikum Hamburg-Eppendorf, Institute of Oncology in Warsaw, Karolinska Institutet, University Hospital, Limoges, University Hospital, Akershus, University of Roma La Sapienza, Hospital Clinic of Barcelona, Leuven University Medical Center, University Hospital, Ghent, Sorlandet Hospital HF, Northern Norway Regional Health Trust, Helse Stavanger HF, Haukeland University Hospital, St. Olavs Hospital, University of Oslo, Frontier Science Foundation
- Study start
- 25 Aug 2025 (actual)
- Primary completion
- 1 Sep 2033 (estimated)
- Study completion
- 1 Sep 2033 (estimated)
- First posted
- 23 Apr 2025 (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.
The trial is a randomized head-to-head comparison of the benefits, harms and burdens of endoscopic full-thickness resection (eFTR), a novel, minimally invasive endoscopic treatment modality, for early colon cancer as compared to standard-of-care surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| eFTR | Experimental | Procedure: eFTRendoscopic full thickness resection |
| Surgery | Active comparator | Procedure: Surgerystandard-of-care surgery |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (13 listed)
- Newly diagnosed biopsy-confirmed colon cancer (adenocarcinoma) with macroscopic suspicion of submucosal invasion considered removable by EFTR as deemed by the local multidisciplinary team (MDT) at the participating center
- Size ≤20 mm in diameter as deemed by the colonoscopist
- No presence of histopathological high-risk features in biopsy (high grade tumor growth, budding grade 2 or 3, or lymphovascular invasion)
- Patient eligible for surgical removal as deemed by the local MDT at the participating center
- Endoscopic images or video of the tumor
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| eFTRendoscopic full thickness resection | Procedure or surgery | eFTR |
| Surgerystandard-of-care surgery | Procedure or surgery | Surgery |
Primary outcome
Rate of severe adverse events, re-admissions and deaths within 30 days
Time frame: 30 days
co-primary short-term endpoint is the composite rate of rate of severe adverse events, re-admissions and deaths within 30 days following assigned treatment
Rate of cancer recurrence or CRC death after three years
Time frame: 3 years
primary long-term endpoint of CRC death or cancer recurrence or sign of lymph nodes or distant metastases after three years
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 20 Nov 2025.
- Individual participant dataSharing planned: Yes. Only if ethical approval is granted by the other researchers, and the study scientific board has reviewed and approved the proposal
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing eFTR and Surgery in people with Colon Cancer, run by Norwegian Department of Health and Social Affairs at 1 site in Poland.
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 0 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 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 MICHAEL BRETTHAUER, MD PhD (+4790132480, michael.bretthauer@medisin.uio.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of severe adverse events, re-admissions and deaths within 30 days (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 20 Nov 2025.