Multicenter Phase II Study of Stereotactic Ablative Radiotherapy for Hepatocellular Carcinoma ≤ 5 cm
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 54
- 试验地点
- 9
- 主要终点
- Local control rate
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Patient with previous history of abdominal radiation
- •Direct invasion to esophagus, stomach or colon by HCC
研究组 & 干预措施
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
干预措施: Stereotactic ablative radiotherapy (Radiation)
结局指标
主要结局
Local control rate
时间窗: up to 1 year
From the date of SABR to the date of local failure or last follow-up
次要结局
- Overall survival rate(up to 2 years)
- Progression free survival rate(up to 2 years)
- Intrahepatic recurrence free survival rate(up to 2 years)
- Treatment related toxicity(up to 1 year)
研究者
Mi-Sook Kim
Doctor
Korea Cancer Center Hospital