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 remaining patients with inoperable and advanced HCC, trans-arterial chemo-embolization (TACE) has been widely used but TACE alone rarely produces complete response and commonly develops recurrence. Recently several small studies reported high tumor response and local control rate after stereotactic ablative radiotherapy (SABR) alone or with TACE for inoperable HCC. This study will evaluate SABR effect with 60 Gy in 3 fractionations for HCC with size of ≤ 5 cm and 3 cm apart from gastrointestinal tract.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
54
The HCC patients with size ≤5 cm and 3 cm apart from gastrointestinal tract will be included in this study. Total stereotactic ablative radiotherapy (SABR) doses will be 60 Gy in 3 fractionations. Patients receive 3 fractionations separated by \>48 hours. At least 700 ml of normal liver (entire liver minus cumulative GTV) should not receive a total dose of \> 17 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 \> 17 Gy. Dose of esophagus, stomach and intestine do not exceed 30 Gy.
Inje University Haeundae Paik Hospital
Busan, South Korea
Dongnam Institute of Radiological & Medical Sciences
Busan, South Korea
Soon Chun Hyang University Hospital Cheonan
Cheonan, South Korea
Catholic University Incheon St. Mary's Hospital
Incheon, South Korea
Inha University Hospital
Incheon, 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
Local control rate
From the date of SABR to the date of local failure or last follow-up
Time frame: up to 1 year
Overall survival rate
From the date of SABR to the date of death or last follow-up
Time frame: up to 2 years
Progression free survival rate
From the date of SABR to the date of first failure or last follow-up
Time frame: up to 2 years
Intrahepatic recurrence free survival rate
From the date of SABR to the date of Intrahepatic recurrence or last follow-up
Time frame: up to 2 years
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: up to 1 year
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