A Phase II Study Using Hypofractionated Proton Beam Radiotherapy for Hepatocellular Carcinoma
The primary endpoint is local progression free survival. The trial is a single arm phase II
trial with the historical arm. The expected 3-year local progression free survival for
patient with HCC patients treated with proton beam therapy would be 80%. With a power of 80%
and a type I error level of 10%, evaluable 40 patients are required to reject that the null
hypothesis that true 3-year local progression free survival rate is ≤65%. Considering the
10% unevaluable patients due to loss of follow up, a total 45 eligible patients for each
arms will be enrolled.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
local progression-free survival
To evaluate the local progression-free survival (LPFS) in HCC patients treated with hypofractionated proton beam radiotherapy.
Up to 1 year
Tae Hyun Kim, Ph.D
National Cancer Center, Korea
Korea: Food and Drug Administration