NCT00697619已完成2 期
A Prospective, Open-label, Randomized Phase III Study to Evaluate the Efficacy of ZOMETA® (Zoledronic Acid) in Treatment of Bone Metastases in Patients With Stage IV Nasopharyngeal Cancer
Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2005年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Comparing the Level of Urinary N-telopeptide (uNTx) in the Two Arms .
研究概览
简要总结
The purpose of this study is to assess the efficacy of addition of zometa to anti-neoplastic treatment compared with anti-neoplastic treatment alone, as measured by the primary efficacy variable of SREs (Skeletal Related Events) and to assess the safety in nasopharyngeal patients with bone metastases randomized to receive either zometa 4 mg or anti-neoplastic treatment alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >18, either sex
- •Histologically confirmed stage IV nasopharyngeal cancer
- •One bone metastasis at least confirmed by imaging
- •without chemotherapy or radiotherapy after bone metastasis
- •Life expectancy > 6 M
- •ECOG <= 2
- •Adequate bone marrow reserve (WBC > 3.5 x 109/L, Neutrophile > 1.5 x 109/L, Platelet 100 x 109/L, Hb > 90 g/L)
- •Serum creatinine< 2.0 mg/dL (< 1.5 times the upper limit of the normal range for the laboratory of the study center)
- •Signed ICF
排除标准
- •Women who are pregnant or in lactation
- •Patients with hyperostosis
- •Systemic treatment for another cancer within the year prior to study entry
- •Previous or current treatment with any other bisphosphonates, bone- protecting, cytotoxic or targeted therapy
- •Initial serum creatinine >265 micromol/L and/or progressive renal disease
- •Known hypersensitivity to any of the study drugs or to drugs with similar chemical structures
- •Use of investigational agents within 28 days of the Baseline visit, or participating simultaneously in any other clinical studies
- •Severe co-morbidity of any type that may interfere with assessment of the patient for the study
研究组 & 干预措施
Test Group
Experimental
Zometa (zoledronic acid) 4 mg over 15 min IV infusion, every 4 week Anti-neoplastic therapy .Patients can receive concomitant cycles of chemotherapy or radiotherapy.
干预措施: Zometa (zoledronic acid) (Drug)
结局指标
主要结局
Comparing the Level of Urinary N-telopeptide (uNTx) in the Two Arms .
时间窗: Baseline, the first, second and third month
次要结局
未报告次要终点
研究者
Li Zhang
Professor
Sun Yat-sen University
研究点 (1)
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