This phase 3 study is to evaluate the effectiveness of the comparison between radiofrequency ablation and hypofractionated proton beam radiation.
The sample size for this study was based on a non-inferiority design. Primary objective: estimate local progression-free survival (LPFS) rate in two treatments Primary endpoint: 2-year LPFS rate Expected 2-year LPFS rate in the RFA: 85% Accural time and follow up time: 24 months and 24 months, respectively. Precision for 2-year LPFS rate estimation: Allowing a difference of 15% as the non-inferiority margin, with a power of 80% and a type I error level of 5%, evaluable 68 patients are required. Considering 5% of follow-up loss, we need 72 patients in each arm, so a total of 144 patients will be enrolled.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
144
\* RFA(radiofrequency ablation ) * RFA electrode: Cool-tip RF ablation system (Covidien plc, 20 Lower Hatch Street Dublin 2, Ireland) and Well-Point RF Electrode (STARmed, Koea) * performed using either the manufacturer's standard algorithm or an interactive algorithm, with the latter being used when the impedance did not begin to increase at the midinterval of the standard algorithm * the duration of a single RFA session was 10 min to 15 min.
\* Proton 66 GyE /10 fx, 6.6 GyE fraction dose, 5 days/week, for HCC free from the alimentary tract (i.e., stomach, duodenum, esophagus, small and large bowel) (more than 2cm from clinical target volume),TLV30\<40%,and/orRLV30\<30%)
National Cancer Center, Korea
Goyang-si, Gyeonggi-do, South Korea
local progression-free survival(LPES)
To evaluate the local progression-free survival for 2 years
Time frame: up to 2 year
disease-free survival (DFS)
Disease-free survival was defined as the interval from the date of randomization to date of detection study closed
Time frame: up to 2 years until study closed
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