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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
35
The HCC patients with major portal vein tumor thrombosis (tumor thrombosis in the main portal vein or 1st branch of portal vein) will be included in this study. Total stereotactic ablative radiotherapy (SABR) doses will be 40 Gy in 4 fractionations. Patients receive 4 fractionations separated by \>48 hours. At least 700 ml of normal liver (entire liver minus cumulative GTV) should not receive a total dose of \> 19.2 Gy in three fractions. If volume of normal liver does not exceed 700 ml, at least 70% of normal liver should not receive a total dose of \> 19.2 Gy. Dose of spinal cord do not exceed 26 Gy. Dose of esophagus, stomach and intestine do not exceed 35 Gy.
Gyeongsang National University Hospital
Jinju, Gyeongsang-nam-do, South Korea
Dongnam Institute of Radiological & Medical Sciences
Busan, South Korea
Keimyung University Dongsan Medical Center
Daegu, South Korea
Catholic University Incheon St. Mary's Hospital
Incheon, South Korea
Inha University Hospital
Incheon, South Korea
Seoul National University Hospital
Seoul, South Korea
Korea Cancer Center Hospital, Korea Institute of Radiological and Medical Sciences
Seoul, South Korea
Soon Chun Hyang University Hospital Seoul
Seoul, South Korea
Tumor stabilization rate
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.
Time frame: 2 months
Overall survival
From the date of SABR to the date of death or last follow-up
Time frame: 6 months, 1 year and 2 year
Tumor progression free survival
From the date of SABR to the date of first failure or last follow-up
Time frame: 6 months, 1 year and 2 year
Treatment related toxicity
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
Time frame: 1 year
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