Colorectal CarcinomaPhase 2LAVA-CRLMNCT03654131
Microwave Ablation Versus Stereotactic Body Radiotherapy for Colorectal Liver Metastases in Oligometastatic Disease: a Prospective, Randomised, Phase 2 Trial
A Phase 2 study testing MWA and SBRT in people with Colorectal Carcinoma and Liver Metastases, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
The LAVA-CRLM trial (Local Ablation Versus Ablative radiotherapy in ColoRectal Liver Metastases) is a prospective, randomised, phase 2 study designed to compare local control and safety of microwave ablation (MWA) versus stereotactic body radiotherapy (SBRT)in patients with colorectal liver metastases and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Carcinoma, Liver Metastases
- What is being tested?
- MWA and SBRT
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteDenmark
- Study dates
- 25 Jul 2018to 3 Dec 2029
- Phase
- Phase 2
- 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
- Colorectal cancer patients with oligo metastatic disease in the liver (1 to 3 tumors), and where metastases are found unsuitable for resection because of
- non-resectability
- small metastasis localized deep in the liver, where a parenchyma sparing intervention is preferred over an extensive resection
- previous extensive liver surgery
- comorbidity
- The multidisciplinary team should all agree that both percutaneous or open surgical MW-ablation and SBRT are safe as first treatment choice for the individual patient.
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- Tumor sizes ≤4.0 cm
- Age > 18 years
- Signed informed consent
Who cannot join
- Previous radiotherapy to the liver
- Liver volume < 700 ml
- Another active cancer disease within the past 36 months
- Not able to understand written or oral protocol information
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Stereotactic Body Radiation Therapy vs. Microwave Ablation for Colorectal Cancer Patients With Metastatic Disease in the Liver - a Randomized Phase II Trail
The LAVA-CRLM trial (Local Ablation Versus Ablative radiotherapy in ColoRectal Liver Metastases) is a prospective, randomised, phase 2 study designed to compare local control and safety of microwave ablation (MWA) versus stereotactic body radiotherapy (SBRT)in patients with colorectal liver metastases and oligometastatic disease. Primary endpoint is freedom form local lesion progression.
Read the detailed description
Colorectal cancer patients with 1-3 liver metastases (diameter ≤4.0 cm) found unsuitable for resection are randomized 1:1 to either MWA or SBRT. Chemotherapy is allowed. Curative treatment of extrahepatic disease must be initiated in patients with lung metastases and/or primary tumors. Patients will be analyzed according to the intention-to-treat principle.
- Conditions
- Colorectal Carcinoma, Liver Metastases
- Being tested
- MWA, SBRT
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MWADevice
Patients are allocated to one of the two arms in a 1:1 randomization
SBRTRadiation
Patients are allocated to one of the two arms in a 1:1 randomization
| Study group | Role | What they receive |
|---|---|---|
| MWA | Active comparator | Percutaneous ultrasound-guided MWA or open surgery MWA. The patient is fully anesthetized during the treatment. Receives: Device: MWA |
| SBRT | Active comparator | 3 fractions of 15 Gy (in total 45 Gy), 3 fractions per week. The dose is prescribed to the PTV encompassing 67% isodose. The SBRT plan is normalized such that the mean dose to the GTV is 100% = 67.5 Gy. Receives: Radiation: SBRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from local lesion progression (analyzed on patient-level)
- Defined as the time from randomization to local progression
- Censoring: death from any cause, last follow-up
- No censoring on disease progression outside of the treated lesions
- Local lesion progression is defined as >20% increase in the longest diameter and minimum 5 mm increase talking as reference the smallest longest diameter recorded since the treatment started in any of the treated lesions
Measured: 1 year
Secondary outcomes (3)
Overall survival
- Defined as the time from randomization to death from any cause
- Censoring: last follow-up
Measured: From enrollment to 01/01/2026 - minimum follow-up 1 year after treatment for all randomised patients.
≥ grade 3 toxicity potentially associated with the treatment
- Using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Measured: 1 month after treatment
Toxicity profile as descriptive statistics
Using the Common Terminology Criteria for Adverse Events (CTCAE) v 5.0
Measured: From enrollment to last follow-up 5 years after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2018
- Study start25 Jul 2018
- Primary completion1 Jan 2026
- Study completion3 Dec 2029 (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 CarcinomaStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- SBRT for oligometastases in the liver from colorectal cancer patients. Standard considered MWA.
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Signe Lenora Risumlund, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03654131
- Sponsor's protocol ID
- H-18000085
- Acronym
- LAVA-CRLM
- Status last verified
- Jan 2026
- First submitted
- 27 Aug 2018
- Last updated
- 19 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data will be made available upon reasonable request to the corresponding author after publication of all analyses of the primary and secondary trial endpoints
Publications
Risumlund SL, Stick LB, Appelt A, Vogelius IR, Nyhuus B, Schultz NA, Penninga L, van Overeem Felter M, Josipovic M, Larsen PN. Microwave ablation versus stereotactic body radiotherapy for oligometastatic colorectal liver metastases (LAVA-CRLM): a prospective, randomised, phase II trial. Lancet Reg Health Eur. 2026 Sep 25;71:101879. doi: 10.1016/j.lanepe.2026.101879. eCollection 2026 Dec.
PubMed 42829779
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stereotactic Body Radiation Therapy vs. Microwave Ablation for Colorectal Cancer Patients With Metastatic Disease in the Liver - a Randomized Phase II Trail
- ClinicalTrials.gov ID
- NCT03654131
- Acronym / sponsor ID
- LAVA-CRLM / H-18000085
- Conditions
- Colorectal Carcinoma, Liver Metastases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 25 Jul 2018 (actual)
- Primary completion
- 1 Jan 2026 (actual)
- Study completion
- 3 Dec 2029 (estimated)
- First posted
- 31 Aug 2018 (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 LAVA-CRLM trial (Local Ablation Versus Ablative radiotherapy in ColoRectal Liver Metastases) is a prospective, randomised, phase 2 study designed to compare local control and safety of microwave ablation (MWA) versus stereotactic body radiotherapy (SBRT)in patients with colorectal liver metastases and oligometastatic disease. Primary endpoint is freedom form local lesion progression.
Detailed description
Colorectal cancer patients with 1-3 liver metastases (diameter ≤4.0 cm) found unsuitable for resection are randomized 1:1 to either MWA or SBRT. Chemotherapy is allowed. Curative treatment of extrahepatic disease must be initiated in patients with lung metastases and/or primary tumors. Patients will be analyzed according to the intention-to-treat principle.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- SBRT for oligometastases in the liver from colorectal cancer patients. Standard considered MWA.
| Arm | Type | Receives |
|---|---|---|
| MWA | Active comparator | Device: MWAPercutaneous ultrasound-guided MWA or open surgery MWA. The patient is fully anesthetized during the treatment. |
| SBRT | Active comparator | Radiation: SBRT3 fractions of 15 Gy (in total 45 Gy), 3 fractions per week. The dose is prescribed to the PTV encompassing 67% isodose. The SBRT plan is normalized such that the mean dose to the GTV is 100% = 67.5 Gy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Colorectal cancer patients with oligo metastatic disease in the liver (1 to 3 tumors), and where metastases are found unsuitable for resection because of
- The multidisciplinary team should all agree that both percutaneous or open surgical MW-ablation and SBRT are safe as first treatment choice for the individual patient.
- Tumor sizes ≤4.0 cm
- Age > 18 years
- Signed informed consent
Key exclusion criteria (4 listed)
- Previous radiotherapy to the liver
- Liver volume < 700 ml
- Another active cancer disease within the past 36 months
- Not able to understand written or oral protocol information
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 |
|---|---|---|
| MWAPatients are allocated to one of the two arms in a 1:1 randomization | Device | MWA |
| SBRTPatients are allocated to one of the two arms in a 1:1 randomization | Radiation | SBRT |
Primary outcome
Freedom from local lesion progression (analyzed on patient-level)
Time frame: 1 year
* Defined as the time from randomization to local progression * Censoring: death from any cause, last follow-up * No censoring on disease progression outside of the treated lesions * Local lesion progression is defined as >20% increase in the longest diameter and minimum 5 mm increase talking as reference the smallest longest diameter recorded since the treatment started in any of the treated lesions
3 secondary outcomes
Overall survival
Time frame: From enrollment to 01/01/2026 - minimum follow-up 1 year after treatment for all randomised patients.
≥ grade 3 toxicity potentially associated with the treatment
Time frame: 1 month after treatment
Toxicity profile as descriptive statistics
Time frame: From enrollment to last follow-up 5 years after treatment
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 19 Mar 2026.
- Derived from this study: PubMed 42829779Risumlund SL, Stick LB, Appelt A, Vogelius IR, Nyhuus B, Schultz NA, Penninga L, van Overeem Felter M, Josipovic M, Larsen PN. Microwave ablation versus stereotactic body radiotherapy for oligometastatic colorectal liver metastases (LAVA-CRLM): a prospective, randomised, phase II trial. Lancet Reg Health Eur. 2026 Sep 25;71:101879. doi: 10.1016/j.lanepe.2026.101879. eCollection 2026 Dec.
- Individual participant dataSharing planned: Yes. De-identified individual participant data will be made available upon reasonable request to the corresponding author after publication of all analyses of the primary and secondary trial endpoints
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MWA and SBRT in people with Colorectal Carcinoma and Liver Metastases, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 9 inclusion and 4 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 19 Mar 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 Denmark. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
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?
Freedom from local lesion progression (analyzed on patient-level) (time frame: 1 year). 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 NCT03654131, 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 19 Mar 2026.