Colorectal Cancer MetastaticNEW-COMETNCT05129787
Ablation vs Resection of Colorectal Cancer Liver Metastases
A study testing Surgical resection and Thermal ablation in people with Colorectal Cancer Metastatic, run by Oslo University Hospital at 1 site in Norway.
Trial summary
230 patients with colorectal cancer liver metastases will be randomly assigned to resection or thermal ablation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer Metastatic
- What is being tested?
- Surgical resection and Thermal ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 1 siteNorway
- Study dates
- 16 Dec 2021to 23 Oct 2030
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically verified colorectal cancer
- Colorectal liver metastases (proven or suspected) eligible for radical treatment using EITHER resection OR ablation (not a combination), as decided by the liver MDT meeting at the study center
- The patient is fit to undergo both resection and ablation of all liver metastases
- Size of largest lesion up to and including 30 mm
- In case of solitary metastasis, resection plan includes resection of ≤ 2 anatomical segments.
- In case of multiple metastases in one continuous resection, resection plan can include ≤ 4 anatomical segments (including hemihepatectomy)
- ≤ 5 tumors to be treated in one procedure
- Primary tumor either resected (primary first) or with a plan for curative treatment (liver first).
Who cannot join
- More than 3 lung metastases where 1 is >10mm, or 1 lung metastasis >15 mm (OR: unresectable lung metastases as decided by the lung MDT meeting)
- Presence of extrahepatic, extrapulmonary metastases.
- Surgical indication for removal of enlarged lymph nodes in the hepatic hilum. (Enlarged lymph nodes without indication of removal are not considered an exclusion criterium)
- Tumor closer than 10 mm to right/left main bile duct
- Suspected tumor infiltration to adjacent organs
- Progression (as of RECIST [18]) on 2nd line chemotherapy
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- Previous inclusion in this trial
- Not eligible for workup according to study criteria
- Contraindication to contrast enhanced CT scan
- Manifest liver cirrhosis
- Pregnancy
- ECOG performance status ≥3
- Simultaneous resection of primary tumor or any other concomitant surgical procedure
- Any other reason why, in the investigator's opinion, the patient should not be included.
Trial locations and contacts
1 site in 1 country.
Norway1 site
Oslo University Hospital, Department of Gastrointestinal surgery, The National Hospital
Oslo, 0424
About this study
Official title: A Randomized Controlled Trial of Needle Ablation With 3D Verification vs Surgical Resection of Colorectal Cancer Liver Metastases
230 patients with colorectal cancer liver metastases will be randomly assigned to resection or thermal ablation.
Read the detailed description
Rationale: The use of thermal ablation of liver tumors is rapidly increasing. This is despite a lack of high-level evidence of the oncologic efficacy of ablation. Ablation is most often used in cases where resection is not possible, but as the technique has improved it is increasingly used as a substitute for resection. A majority of studies on ablation are hampered by selection bias. Selection bias can only be overcome in a randomized controlled trial.
Primary objective:
To compare rates of local tumor progression within 12 months in patients randomly assigned to thermal ablation or surgical resection of colorectal liver metastases.
Secondary objectives:
- To establish a pipeline for immediate three-dimensional verification of the ablated zone following thermal ablation of liver metastases.
- To compare health related quality of life in patients randomly assigned to thermal ablation or surgical resection of colorectal liver metastases.
- To perform a cost-effectiveness analysis (Cost per quality adjusted life year) of thermal ablation and resection of colorectal liver metastases.
- To compare disease-free and overall survival in in patients randomly assigned to thermal ablation or surgical resection of colorectal liver metastases.
- To evaluate the hemodynamic response to thermal ablation and laparoscopic resection of liver tumors.
Study design:
A randomized, controlled, multicenter, double-blinded non-inferiority trial.
Study population:
Two groups of 115 patients (230 in total) with colorectal liver metastasis eligible for radical treatment using EITHER resection OR ablation (not a combination).
Intervention:
Ablation of colorectal liver metastases
Control:
Resection of colorectal liver metastases
Main study parameters/endpoints:
The primary endpoint of the study is local recurrence of cancer at 12 months. Secondary endpoints include overall survival, disease free survival, health related quality of life, postoperative pain, complications, hospital stay and cost-effectiveness.
- Conditions
- Colorectal Cancer Metastatic
- Being tested
- Surgical resection, Thermal ablation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical resectionProcedure or surgery
Resection of metastasis
Thermal ablationProcedure or surgery
Ablation of metastasis
| Study group | Role | What they receive |
|---|---|---|
| Surgical resection | Active comparator | Liver resection Receives: Procedure: Surgical resection |
| Thermal ablation | Experimental | Thermal ablation (Microwave or radiofrequency) Receives: Procedure: Thermal ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local tumor progression
Local tumor progression at site of treatment
Measured: 12 months
Secondary outcomes (10)
Overall survival
Overall survival following treatment
Measured: 60 months
Overall survival (secondary analysis)
A secondary analysis will be performed on a oncologically more homogenous group of patients that fulfil the following requirements: a) no previous surgical procedure on the liver, b) no extrahepatic metastases, and c) that had their primary tumor resected
Measured: 60 months
Disease free survival
DFS
Measured: 60 months
Postoperative complications
Morbidity
Measured: 30 days
Health related quality of life
HRQoL is measured using SF-36
Measured: 12 months
Cost-Effectiveness
An analysis of cost will be performed to assess cost-effectiveness
Measured: 12 months
Hemodynamic response
The hemodynamic response to the two interventions will be recorded and compared
Measured: 7 days
Ventilation methods
The intraoperative movement of the liver will be measured using different ventilation methods (one lung ventilation, jet ventilation, gentle double lung ventilation). The movement of the liver during the different ventilation methods will be assessed in cm.
Measured: 1 day
Cerebral flow
Intraoperative cerebral blood flow will be measured and related to cardiac output and other hemodynamic measures. Micro bubbles caused by the treatment will be visualized using ultrasonography.
Measured: 1 day
Inflammatory response
The inflammatory response (cytokines, complement, catecholamines) will be compared.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2021
- Study start16 Dec 2021
- Primary completion23 Oct 2026 (estimated)
- Study completion23 Oct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal Cancer MetastaticStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Åsmund Avdem Fretland, Oslo University Hospital
- Investigators
- Bjørn Edwin, Professor, Study director, Head of clinical research, The Intervention Centre, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05129787
- Sponsor's protocol ID
- REK255384
- Acronym
- NEW-COMET
- Status last verified
- Feb 2026
- First submitted
- 2 Nov 2021
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD maybe shared pending approval from local data protection officer
Publications
Hansen IS, Lappen KR, Brudvik KW, Rosok BI, Bjork I, Ostergaard D, Andersen MH, Pelanis E, Espinoza AW, Halvorsen PS, Yaqub S, Lassen K, von Gohren Edwin B, Syversveen T, Fretland AA. A Randomized Controlled Trial of Resection Versus Thermal Ablation of Colorectal Cancer Liver Metastases (New Comet): Study Protocol. Ann Surg Oncol. 2025 Nov;32(12):9146-9153. doi: 10.1245/s10434-025-17984-5. Epub 2025 Aug 26.
PubMed 40858956
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Needle Ablation With 3D Verification vs Surgical Resection of Colorectal Cancer Liver Metastases
- ClinicalTrials.gov ID
- NCT05129787
- Acronym / sponsor ID
- NEW-COMET / REK255384
- Conditions
- Colorectal Cancer Metastatic
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- 16 Dec 2021 (actual)
- Primary completion
- 23 Oct 2026 (estimated)
- Study completion
- 23 Oct 2030 (estimated)
- First posted
- 22 Nov 2021 (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.
230 patients with colorectal cancer liver metastases will be randomly assigned to resection or thermal ablation.
Detailed description
Rationale: The use of thermal ablation of liver tumors is rapidly increasing. This is despite a lack of high-level evidence of the oncologic efficacy of ablation. Ablation is most often used in cases where resection is not possible, but as the technique has improved it is increasingly used as a substitute for resection. A majority of studies on ablation are hampered by selection bias. Selection bias can only be overcome in a randomized controlled trial.
Primary objective:
To compare rates of local tumor progression within 12 months in patients randomly assigned to thermal ablation or surgical resection of colorectal liver metastases.
Secondary objectives:
- To establish a pipeline for immediate three-dimensional verification of the ablated zone following thermal ablation of liver metastases.
- To compare health related quality of life in patients randomly assigned to thermal ablation or surgical resection of colorectal liver metastases.
- To perform a cost-effectiveness analysis (Cost per quality adjusted life year) of thermal ablation and resection of colorectal liver metastases.
- To compare disease-free and overall survival in in patients randomly assigned to thermal ablation or surgical resection of colorectal liver metastases.
- To evaluate the hemodynamic response to thermal ablation and laparoscopic resection of liver tumors.
Study design:
A randomized, controlled, multicenter, double-blinded non-inferiority trial.
Study population:
Two groups of 115 patients (230 in total) with colorectal liver metastasis eligible for radical treatment using EITHER resection OR ablation (not a combination).
Intervention:
Ablation of colorectal liver metastases
Control:
Resection of colorectal liver metastases
Main study parameters/endpoints:
The primary endpoint of the study is local recurrence of cancer at 12 months. Secondary endpoints include overall survival, disease free survival, health related quality of life, postoperative pain, complications, hospital stay and cost-effectiveness.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgical resection | Active comparator | Procedure: Surgical resectionLiver resection |
| Thermal ablation | Experimental | Procedure: Thermal ablationThermal ablation (Microwave or radiofrequency) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histologically verified colorectal cancer
- Colorectal liver metastases (proven or suspected) eligible for radical treatment using EITHER resection OR ablation (not a combination), as decided by the liver MDT meeting at the study center
- The patient is fit to undergo both resection and ablation of all liver metastases
- Size of largest lesion up to and including 30 mm
- In case of solitary metastasis, resection plan includes resection of ≤ 2 anatomical segments.
Key exclusion criteria (14 listed)
- More than 3 lung metastases where 1 is >10mm, or 1 lung metastasis >15 mm (OR: unresectable lung metastases as decided by the lung MDT meeting)
- Presence of extrahepatic, extrapulmonary metastases.
- Surgical indication for removal of enlarged lymph nodes in the hepatic hilum. (Enlarged lymph nodes without indication of removal are not considered an exclusion criterium)
- Tumor closer than 10 mm to right/left main bile duct
- Suspected tumor infiltration to adjacent organs
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 |
|---|---|---|
| Surgical resectionResection of metastasis | Procedure or surgery | Surgical resection |
| Thermal ablationAblation of metastasis | Procedure or surgery | Thermal ablation |
Primary outcome
Local tumor progression
Time frame: 12 months
Local tumor progression at site of treatment
10 secondary outcomes
Overall survival
Time frame: 60 months
Overall survival (secondary analysis)
Time frame: 60 months
Disease free survival
Time frame: 60 months
Postoperative complications
Time frame: 30 days
Health related quality of life
Time frame: 12 months
Cost-Effectiveness
Time frame: 12 months
Hemodynamic response
Time frame: 7 days
Ventilation methods
Time frame: 1 day
Cerebral flow
Time frame: 1 day
Inflammatory response
Time frame: 7 days
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 12 Feb 2026.
- Derived from this study: PubMed 40858956Hansen IS, Lappen KR, Brudvik KW, Rosok BI, Bjork I, Ostergaard D, Andersen MH, Pelanis E, Espinoza AW, Halvorsen PS, Yaqub S, Lassen K, von Gohren Edwin B, Syversveen T, Fretland AA. A Randomized Controlled Trial of Resection Versus Thermal Ablation of Colorectal Cancer Liver Metastases (New Comet): Study Protocol. Ann Surg Oncol. 2025 Nov;32(12):9146-9153. doi: 10.1245/s10434-025-17984-5. Epub 2025 Aug 26.
- Individual participant dataSharing planned: Yes. IPD maybe shared pending approval from local data protection officer
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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. This study is not recruiting at the moment.
Bjørn Edwin, Professor study director
Head of clinical research, The Intervention Centre, Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical resection and Thermal ablation in people with Colorectal Cancer Metastatic, run by Oslo University Hospital at 1 site in Norway.
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 8 inclusion and 14 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: under way, not looking for participants, as of the sponsor's last update on 12 Feb 2026. 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 Norway. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local tumor progression (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05129787, which also lists 1 linked publication.
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 12 Feb 2026.