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

Phase 2Active Not RecruitingNCT03654131

Rigshospitalet, Denmark100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Colorectal Carcinoma Liver Metastases

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

* 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

Time frame: 1 year

Secondary Outcomes

Overall survival

* Defined as the time from randomization to death from any cause * Censoring: last follow-up

Time frame: 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

\- Using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0

Time frame: 1 month after treatment

Toxicity profile as descriptive statistics

Using the Common Terminology Criteria for Adverse Events (CTCAE) v 5.0

Time frame: From enrollment to last follow-up 5 years after treatment