NCT00890903已完成不适用
Usage of Vinorelbin ORAL (Navelbine® ORAL) in the Treatment of Advanced Non-small Cell Lung Cancer(NSCLC)and Advanced Breast Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Progression-free-survival
研究概览
简要总结
The purpose of this non-interventional study is to collect data on efficacy and toxicity of the use of Navelbine ORAL in daily routine in Germany (especially after availability of an 80mg capsule). The study focusses on concomitant antiemetic therapy and patient compliance.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •At least 18 years old
- •Male and female patients
- •Advanced NSCLC (Stage III or IV) or Antracycline-resistant MBC
- •Therapy with Navelbine capsules in any palliative treatment line
- •Signed patient informed consent
排除标准
- •Pregnancy and nursing
- •All other exclusion criteria listed in SPC (summary of product characteristics)
- •lack of signed Patient informed consent
结局指标
主要结局
Progression-free-survival
时间窗: 1 year after LPI
次要结局
- Adverse reactions(1 year after LPI)
- Time to progression(1 year after LPI)
- Therapy performance in the daily routine(1 year after LPI)
- Concomitant antiemetic therapy(1 year after LPI)
- Recording of combinations of applied capsules (requested by a patients' questionnaire)(1 year after LPI)
- General condition of patients (requested by a patients' questionnaire)(1 year after LPI)
- Patient compliance(1 year after LPI)
研究者
研究点 (1)
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