Stereotactic Ablative Radiotherapy for Hepatocellular Carcinoma With Major Portal Vein Invasion
- Conditions
- Hepatocellular CarcinomaPortal Vein Tumor Thrombus
- Interventions
- Radiation: Stereotactic ablative radiotherapy
- Registration Number
- NCT01850368
- Lead Sponsor
- Korea Cancer Center Hospital
- 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 EBRT is composed of many fractions (20-35 fractions). On the other hand, stereotactic ablative radiotherapy is a newly emerging treatment method to deliver a high dose of radiation to the target using a few fractions with a high precision within body. SABR increases radiation biologic effect for tumor, makes patients more comfortable due to reduction of the number of hospital visit, and enables patients to receive another treatment more quickly. This study will evaluate SABR effect with 40 Gy in 4 fractions for HCC with major portal vein tumor thrombosis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 35
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Stereotactic ablative radiotherapy Stereotactic ablative radiotherapy Stereotactic ablative radiotherapy for HCC patients with major portal vein tumor thrombosis (tumor thrombosis in the main portal vein or 1st branch of portal vein)
- Primary Outcome Measures
Name Time Method Tumor stabilization rate 2 months Tumor stabilization rate was based on the combined number of patients with complete response(CR), partial response(PR), and stable disease(SD) by modified Response Evaluation Criteria in Solid Tumors (mRECIST) criteria.
- Secondary Outcome Measures
Name Time Method Overall survival 6 months, 1 year and 2 year From the date of SABR to the date of death or last follow-up
Tumor progression free survival 6 months, 1 year and 2 year From the date of SABR to the date of first failure or last follow-up
Treatment related toxicity 1 year Adverse events using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0; Classic radiation induced liver disease; Non-classic Classic radiation induced liver disease; Worsening of Child-Turcotte-Pugh score; Worsening of MELD score
Trial Locations
- Locations (8)
Keimyung University Dongsan Medical Center
🇰🇷Daegu, Korea, Republic of
Soon Chun Hyang University Hospital Seoul
🇰🇷Seoul, Korea, Republic of
Korea Cancer Center Hospital, Korea Institute of Radiological and Medical Sciences
🇰🇷Seoul, Korea, Republic of
Gyeongsang National University Hospital
🇰🇷Jinju, Gyeongsang-nam-do, Korea, Republic of
Inha University Hospital
🇰🇷Incheon, Korea, Republic of
Dongnam Institute of Radiological & Medical Sciences
🇰🇷Busan, Korea, Republic of
Catholic University Incheon St. Mary's Hospital
🇰🇷Incheon, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of