NCT01737216Unknown2 期
Pilot Study of Zoledronic Acid in Combination With First-line Chemotherapy in Aged Patients With Lung Cancer
Hebei Tumor Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2012年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Progression-free survival(PFS)
研究概览
简要总结
Pilot study of Zoledronic acid in combination with first-line chemotherapy in aged patients with lung cancer. The purpose is to assess the effects of Zoledronic acid in combination with first-line chemotherapy in aged patients with lung cancer on bone mineral density gain in the lumbar spine and total hip.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent form
- •Age ≥70 years
- •Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1
- •Histologically or cytologically confirmed lung cancer
- •Did not receive bisphosphonate treatment
排除标准
- •Appear relapse and metastasis
- •receive other bisphosphonate treatment
- •Active or uncontrolled infection
- •Pregnant or lactating women
研究组 & 干预措施
Zoledronic acid plus First-line chemotherapy
Experimental
干预措施: Zoledronic acid plus EP/TP (Drug)
First-line chemotherapy
Active Comparator
干预措施: EP/TP (Drug)
结局指标
主要结局
Progression-free survival(PFS)
时间窗: 1 year
次要结局
- Overall survival(OS)(3 years)
- Bone mineral density(BMD)(1 year)
- Quality of life(QOL)(1 year)
研究者
研究点 (1)
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