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

National Cancer Center (NCC)

Status

Completed

Conditions

Residual Small Hepatocellular Carcinoma

Recurrent Small Hepatocellular Carcinoma

Treatments

Procedure: radiofrequency ablation

Radiation: Proton beam therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT01963429

NCCCTS 13-695

Details and patient eligibility

About

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

Full 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.

Enrollment

144 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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