Stereotactic ablative radiotherapy for hepatocellular carcinoma with major portal vein invasion: A phase II study

Not Applicable

• Conditions: Neoplasms

• Registration Number: KCT0000542
• Lead Sponsor: Korea Institute of Radiological & Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 11 March 2019

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

1. Male or female patients =18 years of age
2. Eastern Cooerative Oncology Group performance status 0 or 1
3. HCC with major portal vein tumor thrombosis (tumor thrombosis in the main portal vein or 1st branch of portal vein)
4. Cirrhotic status of Child Pugh class A or B7
5. 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.
6. Patient or gaurdian must be able to provide verbal and written informed consent

Exclusion Criteria

1. Prior trans-arterial chemo-embolization =4 after diagnosis of major portal vein tumor thrombosis
2. Severe complication caused by liver cirrhosis eg. variceal bleeding, poorly controlled ascites, hepatic encephalopathy)
3. Uncontrolled inter-current illness except liver cirrhosis

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Tumor stabilization rate

Secondary Outcome Measures

Name	Time	Method
Overall survival;Tumor progression free survival;Treatment related toxicity