Status:
COMPLETED
Stereotactic Body Radiation Therapy for Hepatocellular Carcinoma
Lead Sponsor:
Korea Cancer Center Hospital
Collaborating Sponsors:
Dongnam Institute of Radiological & Medical Sciences
Soonchunhyang University Hospital
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
20+ years
Phase:
PHASE2
Brief Summary
The standard treatment for hepatocellular carcinoma (HCC) is surgery, such as, by hepatic resection or liver transplantation, but less than 20% of HCC patients are suitable for surgery. In the remaini...
Eligibility Criteria
Inclusion
- Male or female patients ≥ 20 years of age
- Initially diagnosed or recurrent hepatocellular carcinoma (HCC)
- Unresectable HCC
- Inaccessible to local ablative treatment
- Cirrhotic status of Child Pugh class A or B7
- Eastern Cooperative Oncology Group performance status 0 or 1
- Tumor size \< 10cm
- The volume of uninvolved must be at least 700 ml
- Incomplete response after trans-arterial chemo-embolization of 1-5
- A single lesion or multiple lesions including portal vein tumor thrombosis included in radiation field with one or consecutive sessions of SBRT
- No evidence of an uncontrolled lesion at any other site
- No evidence of complications of liver cirrhosis
- No evidence of uncontrolled inter-current illness
- Patient or guardian must be able to provide verbal and written informed consent
Exclusion
- Patient with previous history of abdominal radiation
- Direct invasion to esophagus, stomach or colon by HCC
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2017
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT01850667
Start Date
January 1 2012
End Date
September 1 2017
Last Update
September 20 2019
Active Locations (7)
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1
Inje University Haeundae Paik Hospital
Busan, South Korea, 612-896
2
Dongnam Institute of Radiological & Medical Sciences
Busan, South Korea
3
Soon Chun Hyang University Hospital Cheonan
Cheonan, South Korea
4
Catholic University Incheon St. Mary's Hospital
Incheon, South Korea