hepatocellular carcinoma Liver cancer
Conditions
Interventions
Radiofrequency ablation
Patients will be admitted to the hospital one day before the procedure or on
the day of the procedure. The procedure will be performed under general
anesthesia or deep sedati
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: * Informed consent * Age > 18 years * Single HCC lesion with diameter of * 2-5cm or up to three lesions with each lesion measuring no more than 3cm (confined to one liver lobe) * HCC diagnosis is based on histology or non-invasive imaging criteria according to EORTC-EASL guidelines * Child Pugh A or B * 7 * ECOG performance status * 2 * Bilirubin
Exclusion criteria
Exclusion criteria: * Tumor location precluding percutaneous RFA * Treatment area >50% of total liver volume, based on CBCT images * Vascular tumor invasion or extrahepatic metastasis * Main portal vein thrombosis * Hemihepatectomy * Severe comorbidity (e.g. cardiovascular disease, diabetes with nephropathy, active infections) * Uncorrectable coagulopathy * Large arterio-portovenous shunt * Previous radiotherapy to the liver * Surgical hepatico-enterostomy * Hepatic resection with placement of surgical clips that may cause artefacts on MRI * Incompetent / mentally disabled * Pregnancy, inadequate anticonception * Calculated lung dose >30Gy * Creatinine clearance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Establishment of treatment area dose at which 90% technical success is achieved. Technical success will be defined as * 120Gy calculated radiation absorbed dose to the target area, i.e. the hyperaemic zone surrounding the area of post-RFA coagulation necrosis. | — |
Secondary
| Measure | Time frame |
|---|---|
| * Toxicity of RFA with adjuvant segmental radioembolization as assessed by complications according to CTCAE v4.0 * Local tumor recurrence at 6 months as assessed by multiphase CT or dynamic MRI * Local tumor recurrence rate at 12 months as assessed by multiphase CT or dynamic MRI * Time-to-progression * Progression free-survival and overall survival at 1 year * Quality of Life | — |
Countries
Netherlands
Outcome results
None listed