Use of TheraSphere® Yttrium-90 Glass Microspheres for Primary and Metastatic Liver Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 81
- 试验地点
- 2
- 主要终点
- Tumor response rates, in terms of size, volume, contrast enhancement and PET avidity
研究概览
简要总结
The purpose of this study is to provide supervised access to treatment with TheraSphere® to eligible patients with primary and metastatic cancer and evaluate response to treatment, survival and toxicity.
The study has the following objectives:
- Provide supervised access to treatment with TheraSphere to eligible patients with primary and metastatic cancer to the liver.
- Evaluate patient experience and toxicities associated with TheraSphere treatment
- Evaluate predisposing factors that may influence results and toxicity
详细描述
This study will use angiographic administration of radioactive TheraSphere® Yttirum-90 microspheres into the hepatic artery, to treat 50 patients with primary or secondary cancer involving the liver. The study population are those who have failed standard therapies, have a majority of their cancer in the liver, have a good performance status and reasonable hepatic function. Outcomes being studied are response to treatment, survival and toxicity.
- Range of patients who can be offered TheraSphere®
- Tumor response rates, in terms of size, volume, contrast enhancement and PET avidity
- Survival time
- Determine response in relation to histology and other parameters
- Ability to tolerate repeat treatments
- Toxicity, which may include radiation induced liver damage, pain, consequences of shunting, toxic deaths.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cancer visible in liver on CT,MR,US or PET scan.
- •Primary cancer in the liver (hepatocellular carcinoma), or metastatic cancer involving the liver from a primary such as but not limited to lung, breast, colon, upper GI, neuroendocrine, melanoma.
- •Life expectancy greater than 2 months
- •Performance status of ECOG 2 or better (Ambulatory and capable of all selfcare, but unable to carry out any work activities. Up and about more than 50% of waking hours.)
- •Patients have tried and/or are aware of all FDA approved therapies for their condition.
排除标准
- •Vascular shunt that cannot be corrected.
- •Bulky cancer outside of liver. Active cancer within the liver should be a greater volume than the active cancer outside the liver / in the remainder of body.
- •Hematologic primary such as lymphoma, leukemia, myeloma.
- •Body weight 300 lbs. and above
- •Evidence of portal hypertension, splenomegaly or ascites.
结局指标
主要结局
Tumor response rates, in terms of size, volume, contrast enhancement and PET avidity
时间窗: 2 to 3 months after treatment(s) up to 2 years
Toxicity, which may include radiation induced liver damage, pain, consequences of shunting, toxic deaths.
时间窗: 2 years
Survival time
时间窗: 2 years
次要结局
未报告次要终点