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

Not Applicable
Recruiting
Conditions
Neoplasms
Registration Number
KCT0000422
Lead Sponsor
Korea Institute of Radiological & Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
71
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

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

Study & Design

Study Type
Interventional Study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
ocal control rate;Severe treatment related toxicity
Secondary Outcome Measures
NameTimeMethod
Overal survival;Progression free survival;Patterns of failure;Intrahepatic recurrence free survival
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