Phase II multicenter study of Stereotactic Body Radiation Therapy for Hepatocellular Carcinoma

Phase II multicenter study of Stereotactic Body Radiation Therapy for Hepatocellular Carcinoma: toxicity and outcome

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

CRIS

Registry ID

KCT0000422

Enrollment

Registered

2012-04-27

Start date

2012-01-25

Completion date

Unknown

Last updated

2019-03-11

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

Conditions

None listed

Interventions

Radiation : Total stereotactic Body radiotherapy (SBRT) doses will be 60 Gy in 3 fractionations. Patients receive 3 fractionations separated by >48 hours. At least 700 ml of normal liver (entire liver

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Male or female patients = 18 years of age 2. Intitially diagnosed or recurrent hepatocellular carcinoma (HCC) 3. Unresectable HCC 4. Cirrhotic status of Child Pugh class A or B7 5. Eastern Cooerative Oncology Group performance status 0 or 1 6. Tumor size < 10cm 7. The volume of uninvolved must be at least 1000 ml 8. Incomplete response after trans-arterial chemo-embolization of 1-5 9. A single lesion or multiple lesions including portal vein tumor thrombosis included in radiation field with one or consecutive sesseions of SBRT 10. No evidence of an uncontrolled lesion at any other site 11. No evidence of complications of liver cirrhosis 12. No evidence of uncontrolled inter-current illness 13. Patient or gaurdian must be able to provide verbal and written informed consent

Exclusion criteria

Exclusion criteria: 1. Patient with previous history of abdominal radiation 2. Direc invasion to esophagus, stomach or colon by HCC

Design outcomes

Primary

Measure	Time frame
Local control rate;Severe treatment related toxicity	—

Secondary

Measure	Time frame
Overal survival;Progression free survival;Patterns of failure;Intrahepatic recurrence free survival	—

Countries

Korea, Republic of

Contacts

Public ContactSun Hyun Bae

Korea Institute of Radiological & Medical Sciences

Outcome results