Liver cancer Liver neoplasm
Conditions
Interventions
Radiofrequency ablation
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Patients that have signed written informed consent 2. Patients undergoing percutaneous or laparascopic radiofrequency ablation for colorectal liver metastases, i.e., patients with metastases limited to the liver that are not surgically resectable. 3. Patients of whom their largest liver metastasis does not exceed 4 cm. 4. Patients with metastases that are not adjacent to or incorporated in one of the large vessels or biliary tract 5. Patients with metastases > 1 cm distance from the liver hilus. 6. Patients with 3 metastases or less 7. Age > 18 years. 8. ECOG Performance Status of 0 tm 2. 9. Life expectancy of at least 12 weeks. 10. Subjects with at least one uni-dimensional(for RECIST) or bi-dimensional (for WHO) measurable lesion. Lesions must be measured by CT-scan or MRI 11. Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening: 12. No concurrent chemotherapy or other anti-tumour therapies.
Exclusion criteria
Exclusion criteria: 1. Extrahepatic metastases 2. WHO performance status > 2 3. Patients undergoing open RFA 4. Patients should not have more than 3 metastases 5. Largest lesion should not exceed 4 cm 6. Patients should not have any tumour adjacent to or incorporated in one of the large vessels or bile structures 7. Patients should not have any tumor situated in less than 1 cm of the liver hilus.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety/ Toxicity: The complication rate of the combination of sorafenib and RFA should not exceed the summarized complication rate of RFA. Toxicity analysis will be based on dose limiting toxicities (DLT*s) considered to be related to sorafenib treatment. RFA-related toxicities are registered in the UMC Utrecht RFA database. Dose limiting toxicities (DLT*s) attributed to the combination of sorafenib and RFA are defined as grade 3 or 4 neutropenia and thrombocytopenia longer than 7 days; febrile neutropenia grade 3 or 4; non-hematological toxicities grade 3 or 4 (excluding ALAT and ASAT levels, alopecia and non pre-medicated nausea/vomiting) Liver failure: Grade 3 / 4 liver function impairment or any other grade 4 toxicity (toxicities are graded according to the CTC version 3.0) Efficacy: Pharmacodynamic assessment: determination of the number of endothelial progenitor cells and cytokines involved in angiogenesis before, during and after RFA. | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease free survival (DFS) after the combination of perioperative sorafenib and RFA | — |
Countries
Netherlands
Outcome results
None listed