Colorectal Carcinoma, Liver Metastases
Conditions
Brief 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.
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.
Interventions
DEVICEMWA
Patients are allocated to one of the two arms in a 1:1 randomization
RADIATIONSBRT
Patients are allocated to one of the two arms in a 1:1 randomization
Sponsors
Rigshospitalet, Denmark
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
SBRT for oligometastases in the liver from colorectal cancer patients. Standard considered MWA.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Toxicity profile as descriptive statistics | From enrollment to last follow-up 5 years after treatment | Using the Common Terminology Criteria for Adverse Events (CTCAE) v 5.0 |
| Overall survival | 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 |
| ≥ grade 3 toxicity potentially associated with the treatment | 1 month after treatment | \- Using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 |
Countries
Denmark
Outcome results
None listed