Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Carcinoma | Colorectal Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Liver Metastases | Colorectal Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MWA | Device | — | UNRESOLVED |
| SBRT | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- MWA
- description
- Percutaneous ultrasound-guided MWA or open surgery MWA. The patient is fully anesthetized during the treatment.
- interventionNames
- Device: MWA
- type
- ACTIVE_COMPARATOR
- label
- SBRT
- description
- 3 fractions of 15 Gy (in total 45 Gy), 3 fractions per week. The dose is prescribed to the PTV encompassing 67% isodose. The SBRT plan is normalized such that the mean dose to the GTV is 100% = 67.5 Gy.
- interventionNames
- Radiation: SBRT
Primary outcomes (1)
- measure
- Freedom from local lesion progression (analyzed on patient-level)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available