NCT01963429

Comparison Between Radiofrequency Ablation and Hypofractionated Proton Beam Radiation for Recurrent/Residual HCC

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)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 144 (actual)
• Sponsor: National Cancer Center, Korea · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase 3 study is to evaluate the effectiveness of the comparison between radiofrequency ablation and hypofractionated proton beam radiation.

Detailed description

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.

Conditions

• Recurrent Small Hepatocellular Carcinoma
• Residual Small Hepatocellular Carcinoma

Interventions

Type	Name	Description
PROCEDURE	radiofrequency ablation	\* RFA(radiofrequency ablation ) * RFA electrode: Cool-tip RF ablation system (Covidien plc, 20 Lower Hatch Street Dublin 2, Ireland) and Well-Point RF Electrode (STARmed, Koea) * performed using either the manufacturer's standard algorithm or an interactive algorithm, with the latter being used when the impedance did not begin to increase at the midinterval of the standard algorithm * the duration of a single RFA session was 10 min to 15 min.
RADIATION	Proton beam therapy	\* Proton 66 GyE /10 fx, 6.6 GyE 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/orRLV30\<30%)

Timeline

• Start date: 2013-09-30
• Primary completion: 2020-01-20
• Completion: 2020-01-20
• First posted: 2013-10-16
• Last updated: 2020-10-06

Locations

1 site across 1 country: South Korea