NCT01290536已完成2 期
Safety Profile Assessment of TheraSphere® Yttrium-90 Glass Microspheres Used for Treatment of Metastatic Liver Disease From Primary Colorectal, Neuroendocrine, Cholangiocarcinoma, Melanoma, and Breast Cancers Refractory to Chemotherapy: A Pilot Study
Nicholas Fidelman, MD0 个研究点目标入组 42 人开始时间: 2010年5月最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 主要终点
- Number of Participants With Adverse Events
研究概览
简要总结
This is a prospective pilot study designed to document safety and efficacy of liver-directed therapy for colorectal, neuroendocrine, cholangiocarcinoma, melanoma, and breast cancer metastases to the liver using Yttrium-90 glass microspheres (TheraSphere).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of metastatic colorectal, neuroendocrine, cholangiocarcinoma, melanoma, or breast malignancy with liver dominant disease. Diagnosis may be made by histo- or cyto-pathology, or by clinical and imaging criteria.
- •The cancer is unresectable.
- •All patients must be off all chemotherapeutic regimens for 30 days prior to and 30 days after TheraSphere treatment. Concurrent therapy with octreotide is permitted, when appropriate.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-
- •Age 18 years or older.
- •Able to understand informed consent.
排除标准
- •Evidence of potential delivery of greater than 16.5 mCi (30 Gy absorbed dose) of radiation to the lungs on either:
- •single TheraSphere administration; or
- •cumulative delivery of radiation to the lungs greater than 50 Gy over multiple treatments.
- •Evidence of any detectable Tc-99m macroaggregated albumin deposition in the stomach or duodenum, after application of established angiographic techniques to stop such deposition.
- •Previous radiation therapy to the lungs and/or to the upper abdomen
- •Pregnancy
- •Symptomatic lung disease.
- •Significant extrahepatic disease representing an imminent life-threatening outcome.
- •Active uncontrolled infection
- •Any pre-treatment laboratory findings within 30 days of treatment demonstrating:
- •Aspartate or alanine aminotransferase level greater than 5 times upper normal limit.
- •Serum bilirubin greater than 2 mg/dl
- •Infiltrative tumor on imaging
- •Tumor volume greater than 70% of liver volume
- •Tumor volume greater than 50% of liver volume and serum albumin level less than 3 mg/dL
研究组 & 干预措施
Yttrium-90 liver radioembolization
Experimental
干预措施: Selective internal radiation therapy to the liver using Yttrium-90 glass microspheres (TheraSphere) (Device)
结局指标
主要结局
Number of Participants With Adverse Events
时间窗: 6 months
Adverse effects of treatment with Yttrium-90 glass microspheres (TheraSphere) were collected prospectively for 6 months after each treatment administration.
次要结局
- Radiographic Response(6 months after treatment)
研究者
Nicholas Fidelman, MD
Principal Investigator
University of California, San Francisco
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