Stereotactic Ablative Radiotherapy for Hepatocellular Carcinoma ≤ 5 cm
- Conditions
- Hepatocellular Carcinoma
- Interventions
- Radiation: Stereotactic ablative radiotherapy
- Registration Number
- NCT01825824
- Lead Sponsor
- Korea Cancer Center Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 54
- Male or female patients ≥ 20 years of age
- Initially diagnosed or recurrent hepatocellular carcinoma (HCC)
- Unresectable HCC
- Cirrhotic status of Child Pugh class A or B7
- Eastern Cooperative Oncology Group performance status 0 or 1
- single or sum of multiple tumor ≤ 5 cm
- HCC with 3 cm apart from gastrointestinal tract
- The volume of uninvolved must be at least 700 ml
- Incomplete response after trans-arterial chemo-embolization of 1-5
- A single lesion or multiple lesions including portal vein tumor thrombosis included in radiation field with one or consecutive sessions of stereotactic body radiation therapy (SBRT)
- No evidence of an uncontrolled lesion at any other site
- No evidence of complications of liver cirrhosis
- No evidence of uncontrolled inter-current illness
- Patient or guardian must be able to provide verbal and written informed consent
- Patient with previous history of abdominal radiation
- Direct invasion to esophagus, stomach or colon by HCC
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Stereotactic ablative radiotherapy Stereotactic ablative radiotherapy Stereotactic ablative radiotherapy for unresectable hepatocellular carcinoma with size ≤ 5 cm and 3cm apart from gastrointestinal tract after incomplete trans-arterial chemo-embolization
- Primary Outcome Measures
Name Time Method Local control rate up to 1 year From the date of SABR to the date of local failure or last follow-up
- Secondary Outcome Measures
Name Time Method Progression free survival rate up to 2 years From the date of SABR to the date of first failure or last follow-up
Overall survival rate up to 2 years From the date of SABR to the date of death or last follow-up
Intrahepatic recurrence free survival rate up to 2 years From the date of SABR to the date of Intrahepatic recurrence or last follow-up
Treatment related toxicity up to 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 (7)
Inje University Haeundae Paik Hospital
🇰🇷Busan, Korea, Republic of
Dongnam Institute of Radiological & Medical Sciences
🇰🇷Busan, Korea, Republic of
Soon Chun Hyang University Hospital Cheonan
🇰🇷Cheonan, Korea, Republic of
Catholic University Incheon St. Mary's Hospital
🇰🇷Incheon, Korea, Republic of
Inha University Hospital
🇰🇷Incheon, Korea, Republic of
Korea Cancer Center Hospital, Korea Institute of Radiological and Medical Sciences
🇰🇷Seoul, Korea, Republic of
Soon Chun Hyang University Hospital Seoul
🇰🇷Seoul, Korea, Republic of