Neoplasms

All Conditions

Digestive System Diseases

Symptoms and General Pathology

Carcinoma

Carcinoma, Hepatocellular

Recurrence

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Disease Attributes

Adenocarcinoma

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

\* 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.

radiofrequency ablation

\* 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%)

Proton beam therapy

Joong Won Park, Ph.D

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.

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)

Overall survival(OS) was defined as the interval from the date of randomization to date of detection study closed

To evaluate the local progression-free survival for 2 years

Disease-free survival was defined as the interval from the date of randomization to date of detection study closed

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Comparison Between Radiofrequency Ablation and Hypofractionated Proton Beam Radiation for Recurrent/Residual HCC	NCT01963429	Recurrent Small... Residual Small ...	radiofrequency ... Proton beam the...	18 Years -	National Cancer Center, Korea
Comparison Between Radiofrequency Ablation and Hypofractionated Proton Beam Radiation for Recurrent/Residual HCC	NCT01963429	Recurrent Small... Residual Small ...	radiofrequency ... Proton beam the...	18 Years -	National Cancer Center, Korea

Spots Global Cancer Trial Database for residual small hepatocellular carcinoma