A Phase III Randomized Controlled Non-inferiority Trial to Compare Stereotactic Body Radiotherapy versus Radiofrequency Ablation for Unresectable, Small (= 3 cm) Hepatocellular Carcinoma
- Conditions
- Neoplasms
- Registration Number
- KCT0007472
- Lead Sponsor
- Asan Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 162
1) patient age between 18 and 80 years old
2) primary or recurrent HCC that is not suitable for surgery
3) HCCs with a longest diameter of =3cm and =2 lesions
4) no evidence of intrahepatic or extrahepatic residual disease except for target lesions
5) Child-Pugh class A or B hepatic function
6) no macroscopic vascular invasion or extrahepatic metastasis
7) written informed consent
1) Eastern Cooperative Oncology Group performance status score 3 or 4
2) uncontrolled ascites, variceal bleeding, or hepatic encephalopathy
3) previous history of liver transplantation
4) an active gastric or duodenal ulcer within 3 months before screening
5) pregnant woman
6) uncontrolled other malignancies except for HCC within 2 years before screening
7) platelet count <50,000/µl
8) Patients who are judged by the researcher to be difficult to conduct clinical research
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 2-year local progression-free survival rate, PP
- Secondary Outcome Measures
Name Time Method 2-year progression-free survival rate, ITT;2-year overall survival rate, PP;2-year overall survival rate, ITT;2-year intrahepatic progression-free survival rate, PP;2-year intrahepatic progression-free survival rate, ITT;2-year progression-free survival rate, PP;2-year progression-free survival rate, ITT;2-year adverse reaction rate, PP;2-year adverse reaction rate, ITT;2-year adverse reaction rate = Gr 3, PP;2-year adverse reaction rate = Gr 3, ITT;Child-Pugh score at 2 year, PP;Child-Pugh score at 2 year, ITT;2-year local progression-free survival rate according to the tumor location, PP;2-year local progression-free survival rate according to the tumor location, ITT