NCT00466856终止2 期
Clinical Trial of Sir-Spheres® in Patients With Symptomatic or Progressive Hepatic Metastases From Neuroendocrine Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Tumor response
研究概览
简要总结
RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.
PURPOSE: This phase II trial is studying how well internal radiation therapy works in treating patients with liver metastases from neuroendocrine tumors.
详细描述
OBJECTIVES:
Primary
- Determine tumor response to selective internal radiation therapy with yttrium Y 90 resin microspheres (Sir-Spheres®) in patients with progressive liver metastases from neuroendocrine tumors.
Secondary
- Determine the toxicity of this treatment in these patients.
- Determine the symptomatic relief of patients treated with this regimen.
- Determine the health-related quality of life of patients receiving this treatment.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Sir-Spheres
Experimental
干预措施: octreotide acetate (Drug)
Sir-Spheres
Experimental
干预措施: yttrium Y 90 resin microspheres (Radiation)
结局指标
主要结局
Tumor response
时间窗: at 1 year or until intervening death
次要结局
- Toxicity as measured by CTC v3.0(at 1 year or until intervening death)
- Symptomatic relief as measured by Carcinoid Symptom Scale, SF-36 Pain scale, and SF-36 physical component summary(at 1 year or until intervening death)
- Patient report of Health-related quality of life (HRQOL)(at 1 year or until intervening death)
研究者
Steven Meranze, MD
Vice-Chair, Department of Radiology and Radiological Science; Professor of Radiology and Surgery; Interventional Radiologist
Vanderbilt-Ingram Cancer Center
研究点 (1)
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