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Completed

NCT Number: NCT01963429

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

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

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Key information

Conditions

Recurrent Small Hepatocellular Carcinoma Residual Small Hepatocellular Carcinoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Cancer Center, Korea

Goyang-si, Gyeonggi-do, 410-769, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • HCC diagnosed as (i) the presence of risk factors including hepatitis B or C virus and liver cirrhosis, a serum a-fetoprotein (AFP) level greater than 200 IU/ml and a radiologically compatible feature with HCC in one or more CT/MRI/angiograms, or (ii) the presence of risk factors including hepatitis B or C virus and liver cirrhosis, a serum a-fetoprotein (AFP) level less than 200 IU/ml, and a radiologically compatible feature with HCC in two or more CT/MRI/angiograms or (iii) histological confirmation
  • HCC patients who had recurrent or residual tumor after other treatments
  • without evidence of extrahepatic metastasis
  • the largest diameter of tumor should be less than 3cm, and the number of tumor ≤2
  • no previous treatment to target tumors by other forms of RT
  • liver function of Child-Pugh class A or B7 (Child-Pugh score of ≤7)
  • Age of ≥18 years
  • performance status of 0 to 2 on the Eastern Cooperative Oncology Group (ECOG) score
  • WBC count ≥ 2,000/mm3; hemoglobin level ≥ 7.5 g/dL; platelet count ≥ 50,000/mm3; and adequate hepatic function (total bilirubin ≤ 3.0 mg/dL; AST and ALT < 5.0× upper limit of normal; no ascites)
  • no serious comorbidities other than liver cirrhosis
  • written informed consent

Exclusion criteria

  • evidence of extrahepatic metastasis
  • age < 18 years
  • liver function of Child-Pugh class B8-9 and C (Child-Pugh score of >7) or uncontrolled cases of active chronic hepatitis B
  • previous history of other forms of RT adjacent to target tumors
  • poor performance status of 3 to 4 on the Eastern Cooperative Oncology Group (ECOG) score
  • pregnant or breast feeding status
  • previous history uncontrolled other malignancies within 2 years

Treatment and study plan

Radiofrequency ablation

Procedure
  • 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.

Proton beam therapy

Radiation
  • 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%)

Primary outcomes

  1. local progression-free survival(LPES)

    Time frame: up to 2 year

    To evaluate the local progression-free survival for 2 years

Secondary outcomes

  1. disease-free survival (DFS)

    Time frame: up to 2 years until study closed

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

Other outcomes

  1. overall survival (OS)

    Time frame: up to 2 years until study closed

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

Sponsors and collaborators

Lead sponsor

National Cancer Center, Korea

Other Gov

Registry information

Official study title

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)

Important dates

Study start
2013
Primary completion
2020
Study completion
2020
First posted
Oct 16, 2013
Registry last updated
Oct 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.