NCT00156884已完成2 期
A Randomized Phase II Trial of Strontium-89 With or Without Cisplatin for the Palliation of Bone Pain Secondary to Hormone Refractory Prostate Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 3
- 主要终点
- Palliative pain response
研究概览
简要总结
This study is designed to determine whether the combination of low dose cisplatin and strontium-89 shows clinical promise for the symptomatic treatment of bone metastases in hormone refractory prostate cancer.
详细描述
This study is designed to determine whether the combination of low dose cisplatin and strontium-89 shows clinical promise for the symptomatic treatment of bone metastases in hormone refractory prostate cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- Male
- 接受健康志愿者
- 否
入选标准
- •adenocarcinoma of the prostate
- •life expectancy > 3 months,
- •symptomatic from bone metastases
- •radiologic evidence of metastatic bone disease
- •stable level of pain control
- •>18 years
- •ability to complete assessments
- •prior treatment (chemo) > 4 weeks previous
- •discontinued anti-androgens for > 4 weeks
排除标准
- •prior strontium therapy
- •previous hemibody RT within 6 weeks
- •previous cytotoxic chemotherapy within 4 weeks
- •use of bisphosphonate medications within 4 weeks
- •change in steroid dose within 4 weeks
- •active uncontrolled infection
- •impending or present spinal cord compression
- •significant neurological disorder
- •impending pathological fracture
- •severe urinary incontinence
结局指标
主要结局
Palliative pain response
analgesic response
次要结局
未报告次要终点
研究者
研究点 (3)
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