Microwave Ablation Versus Stereotactic Body Radiotherapy for Colorectal Liver Metastases in Oligometastatic Disease: a Prospective, Randomised, Phase 2 Trial
MWA: Patients are allocated to one of the two arms in a 1:1 randomization
SBRT: Patients are allocated to one of the two arms in a 1:1 randomization
Study 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 oligometastatic disease. Primary endpoint is freedom form local lesion progression.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Freedom from local lesion progression (analyzed on patient-level) — 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
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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