Spots Global Cancer Trial Database for Hypofractionated Proton Beam Radiotherapy for Inoperable Hepatocellular Carcinoma

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Trial Identification

Brief Title: Hypofractionated Proton Beam Radiotherapy for Inoperable Hepatocellular Carcinoma

Official Title: A Phase II Study Using Hypofractionated Proton Beam Radiotherapy for Inoperable Hepatocellular Carcinoma

Study ID: NCT02395523

Conditions

Hepatocellular Carcinoma

Interventions

Proton Beam Therapy

Study Description

Brief Summary: This phase II study is to evaluate the effectiveness of hypofractionated proton beam therapy (PBT) for Hepatocellular Carcinoma patients in hepatitis B endemic area.

Detailed Description: 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 will be enrolled.