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

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.

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.

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