NCT00848094已完成1 期
Phase I Trial of Radiation Dose Escalation for Locally Advanced Hepatocellular Carcinoma
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 主要终点
- Toxicity was graded using the CTCAE 3.0. Dose-limiting toxicity was defined as acute ≥ grade 3 hepatic or gastrointestinal toxicity, or any grade 5 treatment-related adverse event, or late complication of radiation-induced liver disease.
研究概览
简要总结
The purpose of this clinical study is to determine the maximum tolerated dose (MTD) of 3-dimensional conformal radiation therapy (3-DCRT)/intensity modulated radiation therapy (IMRT) for locally advanced hepatocellular carcinoma (HCC).
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically confirmed or clinically diagnosed HCC
- •Surgically unsectable or medically inoperable diseases, or surgery declined by the patient
- •Solitary intrahepatic lesion with diameter bigger than 5 cm, without extrahepatic and/or distant metastases
- •Associated with cirrhosis of Child-Pugh A
- •Karnofsky performance status (KPS) of ≥ 70
- •Normal renal function and adequate bone marrow reservation
- •Tolerate active breathing control (ABC)
排除标准
- •Child-Pugh B or C liver cirrhosis score
- •Previous radiotherapy to the liver
- •Indistinct tumor boundary in CT/MRI image
研究组 & 干预措施
arm 1
Other
Arm I: tumor diameter more than 5 cm and less than 10 cm.
干预措施: 3DCRT/IMRT (Radiation)
arm 2
Other
Arm II: tumor diameter no less than 10 cm.
干预措施: 3DCRT/IMRT (Radiation)
结局指标
主要结局
Toxicity was graded using the CTCAE 3.0. Dose-limiting toxicity was defined as acute ≥ grade 3 hepatic or gastrointestinal toxicity, or any grade 5 treatment-related adverse event, or late complication of radiation-induced liver disease.
时间窗: 4 months
次要结局
- 1,2 and 3 years survival(4 years)
研究者
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