A Phase III Randomized Controlled Non-inferiority Trial to Compare Stereotactic Body Radiotherapy versus Radiofrequency Ablation for Unresectable, Small (= 3 cm) Hepatocellular Carcinoma

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CRIS

Registry ID

KCT0007472

Enrollment

162

Registered

2022-06-30

Start date

2022-08-01

Completion date

Unknown

Last updated

2022-09-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Procedure/Surgery, Radiation : A total of 162 subjects are randomly assigned to one of two treatment groups (81 patients in the body stereotactic radiotherapy group and 81 patients in the radiofrequen

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
2-year local progression-free survival rate, PP	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

Korea, Republic of

Contacts

Public ContactChaeyeon Lim

Asan Medical Center

codus0421@naver.com+82-2-3010-6293

Outcome results