NCT02395523

Hypofractionated Proton Beam Radiotherapy for Inoperable Hepatocellular Carcinoma

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: National Cancer Center, Korea · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
RADIATION	Proton Beam Therapy	Definition of target volume: * Gross tumor volume (GTV) = gross tumor defined using a treatment planning CT scan * Clinical target volume (CTV) = GTV + internal target volume * Planning target volume (PTV) = CTV + 5 - 7 mm of lateral, craniocaudal, and anteroposterior margins. Radiation dose and planning * Prescription dose to PTV: 70 GyE /10 fx, 7GyE fraction dose, 5 days/week * Dose prescription : 95% isodose volume of prescribed dose encompassed PTV

Timeline

• Start date: 2015-03-05
• Primary completion: 2020-03-26
• Completion: 2020-05-18
• First posted: 2015-03-23
• Last updated: 2020-07-07

Locations

1 site across 1 country: South Korea