NCT00762346已完成4 期
Efficacy and Safety Study of ZOMETA® in Treatment of High-level NTX Non Small Cell Lung Cancer With Bone Metastasis
Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 156 人开始时间: 2008年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 156
- 试验地点
- 1
- 主要终点
- Skeleton-related event
研究概览
简要总结
A multicenter prospective study to assess the efficacy and safety of ZOMETA® in treatment of high-level NTX non small cell lung cancer with bone metastasis.
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
- •Age > 18
- •Histologically confirmed non-small cell cancer
- •One bone metastasis at least confirmed by image(X ray, CT or others)
- •NTX > 50nM BCE/mM creatinine
- •Life expectancy > 6 M
- •ECOG <= 2
- •Signed ICF
排除标准
- •Women who are pregnant or in lactation
- •Patients with hyperostosis with brain metastasis(exception of those without symptom or with Metastasis Lesions under controlled
- •Previous or current treatment with any other bisphosphonates, bone- protecting, cytotoxic or targeted therapy
- •Severe co-morbidity of any type that may interfere with assessment of the patient for the study -
研究组 & 干预措施
1
Experimental
干预措施: zometa (Drug)
结局指标
主要结局
Skeleton-related event
时间窗: 2 years
次要结局
- OS(2 years)
研究者
Li Zhang
Profressor
Sun Yat-sen University
研究点 (1)
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