In this multi-center, dose-finding study, patients with early stage hepatocellular carcinoma according to the Barcelona Clinic Liver Cancer (BCLC) staging system will be included to receive percutaneous radiofrequency ablation in combination with RFA with adjuvant segmental radioembolization.
RFA + adjuvant radioembolsation with Quirem Spheres
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
radioembolisation as adjuvant treatment to RFA
Leiden University Medical Center
Leiden, South Holland, Netherlands
Dose-finding
Treatment area dose that will result in delivery of a radiation absorbed dose of ≥ 120Gy to the target area in at least 90% of patients.
Time frame: 1 year
Toxicity
Toxicity of RFA with adjuvant segmental radioembolization as assessed by complications according to CTCAE v4.0
Time frame: 1 year
Local tumor recurrence
Local tumor recurrence at 6 months as assessed by multiphase CT or dynamic MRI
Time frame: 6 months and 12 months
Time to progression
time until disease progresses
Time frame: 1 year
Progression-free survival
Kaplan-Meier analysis of progression free survival
Time frame: 1 year
Quality of Life
Quality of Life will be assessed by means of the EORTC QLQ HCC-18 questionnaire
Time frame: Throughout the first year after treatment.
Quality of Life
Quality of Life will be assessed by means of the C-30 questionnaire
Time frame: Throughout the first year after treatment.
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