Active — Not RecruitingPhase 2

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

Denmark100 participantsStarted 2018-07-25

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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.
✓. Tumor sizes ≤4.0 cm
✓. Age \> 18 years

Exclusion criteria

✕. 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

What they're measuring

Freedom from local lesion progression (analyzed on patient-level)

Timeframe: 1 year

Trial details

NCT IDNCT03654131

SponsorRigshospitalet, Denmark

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-01-01

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