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NCT Number: NCT03654131

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Colorectal Carcinoma Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Liver Metastases Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Righospitalet

Copenhagen, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • Signed informed consent

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

Treatment and study plan

MWA

Device

Patients are allocated to one of the two arms in a 1:1 randomization

SBRT

Radiation

Patients are allocated to one of the two arms in a 1:1 randomization

Primary outcomes

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

    Time frame: 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 outcomes

  1. Overall survival

    Time frame: 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

  2. ≥ grade 3 toxicity potentially associated with the treatment

    Time frame: 1 month after treatment

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

  3. Toxicity profile as descriptive statistics

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

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

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Official study title

Stereotactic Body Radiation Therapy vs. Microwave Ablation for Colorectal Cancer Patients With Metastatic Disease in the Liver - a Randomized Phase II Trail

Acronym: LAVA-CRLM

Important dates

Study start
2018
Primary completion
2026
Study completion
2029
First posted
Aug 31, 2018
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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