NCT01643824

Hypofractionated Proton Beam Radiotherapy for Hepatocellular Carcinoma

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 112 (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 HCC 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 for each arms will be enrolled.

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
RADIATION	Proton Beam Therapy	\- Prescription dose to PTV as according to the following dose escalation schema: Arml 1: 60 GyE /10 fx, 6GyE 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/or RLV30 \<30%) Arm 2: 50 GyE /10 fx, 5GyE fraction dose, 5 days/week, for HCC close to the alimentary tract (less than 2cm from clinical target volume) but not contact with the alimentary tract, TLV30\<50% and RLV30\<40% Arm 3: 35 GyE /10 fx, 4GyE fraction dose, 5 days/week, for HCC contact to the alimentary tract (contact with clinical target volume), TLV30\<60%, and/or RLV30\<50% \- Dose prescription : 95% isodose volume of prescribed dose encompassed PTV

Timeline

• Start date: 2012-06-07
• Primary completion: 2017-04-30
• Completion: 2017-04-30
• First posted: 2012-07-18
• Last updated: 2018-08-23

Locations

1 site across 1 country: South Korea