Recurrent Small Hepatocellular Carcinoma Clinical Trial
Official title:
A Randomized Phase III Study of the Comparison Between Radiofrequency Ablation and Hypofractionated Proton Beam Radiation in Patients With Recurrent/Residual Small Hepatocellular Carcinoma (APROH Study)
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.
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