Status:
COMPLETED
Stereotactic Ablative Radiotherapy for Hepatocellular Carcinoma With Major Portal Vein Invasion
Lead Sponsor:
Korea Cancer Center Hospital
Collaborating Sponsors:
Seoul National University Hospital
Dongnam Institute of Radiological & Medical Sciences
Conditions:
Hepatocellular Carcinoma
Portal Vein Tumor Thrombus
Eligibility:
All Genders
20+ years
Phase:
PHASE2
Brief Summary
Recently, several studies reported promising outcomes of patients after external beam radiotherapy (EBRT) for hepatocellular carcinoma (HCC) with portal vein tumor thrombosis. However, conventional EB...
Eligibility Criteria
Inclusion
- Male or female patients ≥ 20 years of age
- Initially diagnosed or recurrent hepatocellular carcinoma (HCC)
- Eastern Cooperative Oncology Group performance status 0 or 1
- HCC with major portal vein tumor thrombosis (tumor thrombosis in the main portal vein or 1st branch of portal vein)
- Cirrhotic status of Child Pugh class A or B7
- Patients can have extra-hepatic disease; provided the hepatic disease is the highest burden, the extra-hepatic disease is low burden and potentially treatable with radiotherapy, chemotherapy and target agent etc; patient survival is expected to be at least 6 months.
- Patient or guardian must be able to provide verbal and written informed consent
Exclusion
- Prior trans-arterial chemo-embolization ≥4 after diagnosis of major portal vein tumor thrombosis
- Severe complication caused by liver cirrhosis eg. variceal bleeding, poorly controlled ascites, hepatic encephalopathy)
- Uncontrolled inter-current illness except liver cirrhosis
Key Trial Info
Start Date :
October 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2017
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT01850368
Start Date
October 1 2012
End Date
July 1 2017
Last Update
September 20 2019
Active Locations (8)
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1
Gyeongsang National University Hospital
Jinju, Gyeongsang-nam-do, South Korea, 660-702
2
Dongnam Institute of Radiological & Medical Sciences
Busan, South Korea
3
Keimyung University Dongsan Medical Center
Daegu, South Korea, 700-712
4
Catholic University Incheon St. Mary's Hospital
Incheon, South Korea