Microwave Ablation Versus Stereotactic Body Radiotherapy for Colorectal Liver Metastases in Oligometastatic Disease: a Prospective, Randomised, Phase 2 Trial (LAVA-CRLM)

March 17, 2026 updated by: Signe Lenora Risumlund, Rigshospitalet, Denmark

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark
        • Righospitalet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Colorectal cancer patients with oligo metastatic disease in the liver (1 to 3 tumors), and where metastases are found unsuitable for resection because of

    1. non-resectability
    2. small metastasis localized deep in the liver, where a parenchyma sparing intervention is preferred over an extensive resection
    3. previous extensive liver surgery
    4. comorbidity
  2. 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.
  3. Tumor sizes ≤4.0 cm
  4. Age > 18 years
  5. Signed informed consent

Exclusion Criteria:

  1. Previous radiotherapy to the liver
  2. Liver volume < 700 ml
  3. Another active cancer disease within the past 36 months
  4. Not able to understand written or oral protocol information

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: MWA
Percutaneous ultrasound-guided MWA or open surgery MWA. The patient is fully anesthetized during the treatment.
Device: MWA
Patients are allocated to one of the two arms in a 1:1 randomization
Active Comparator: SBRT
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.
Radiation: SBRT
Patients are allocated to one of the two arms in a 1:1 randomization

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: From enrollment to 01/01/2026 - minimum follow-up 1 year after treatment for all randomised patients.
  • Defined as the time from randomization to death from any cause
  • Censoring: last follow-up
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
- Using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0
1 month after treatment
Toxicity profile as descriptive statistics
Time Frame: From enrollment to last follow-up 5 years after treatment
Using the Common Terminology Criteria for Adverse Events (CTCAE) v 5.0
From enrollment to last follow-up 5 years after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 25, 2018

Primary Completion (Actual)

January 1, 2026

Study Completion (Estimated)

December 3, 2029

Study Registration Dates

First Submitted

August 27, 2018

First Submitted That Met QC Criteria

August 29, 2018

First Posted (Actual)

August 31, 2018

Study Record Updates

Last Update Posted (Actual)

March 19, 2026

Last Update Submitted That Met QC Criteria

March 17, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-18000085

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

IPD Sharing Time Frame

Immediately following publication of all analyses of the primary and secondary trial endpoints and until 5 years after.

IPD Sharing Access Criteria

Investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose for individual participant data meta-analysis. For this please contact the principal investigator of the trial. Data sharing will be conducted in accordance with Danish law on the processing of personal data, regulations of the Danish Data Protection Authority, and applicable health legislation.

Contact Principal investigator Signe Lenora Risumlund Senior Oncologist Department of Oncology, Blegdamsvej 9, 2100 Copenhagen, Capital Region of Denmark, Denmark Signe.lenora.risumlund@regionh.dk

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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