NCT01818947已完成不适用
A Multicentre, Retrospective Chart Review Study to Characterise Gefitinib Usage and Outcomes in Routine Treatment
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 157
- 试验地点
- 12
- 主要终点
- Assessment of treatment duration, as a surrogate of Clinical Benefit (CB) in a 'Real World' population treated with gefitinib
研究概览
简要总结
The purpose of this study is to understand real world gefitinib usage patterns, patient characteristics and outcomes and to present these for a Caucasian population
详细描述
A multicentre, retrospective chart review study to characterise gefitinib usage and outcomes in routine treatment
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
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
- •Patients who received gefitinib first line in the UK Single Payment Access (SPA) scheme
- •Locally advanced or metastatic EGFR mutation positive NSCLC
- •Supplied with first pack of gefitinib prior to 1st January 2012
排除标准
- •Patient was treated privately (i.e. outside the NHS)
- •Gefitinib was second-line therapy following treatment failure on a prior therapy
结局指标
主要结局
Assessment of treatment duration, as a surrogate of Clinical Benefit (CB) in a 'Real World' population treated with gefitinib
时间窗: 6 months
Retrospective population \[2009 to 2013\]
Assessment of Overall Survival (OS) in a 'Real World' population treated with gefitinib
时间窗: 6 months
Retrospective population \[2009 to 2013\]
次要结局
- Duration of treatment in patients stratified by age, gender, stage and performance status.(6 months)
- Assessment of Overall Survival (OS) in the subgroup of patients of Caucasian ethnicity and in the subgroup of patients treated with gefitinib for at least 3 months(6 months)
- Assessment of Treatment duration in the subgroup of patients of Caucasian ethnicity and in the subgroup of patients treated with gefitinib for at least 3 months(6 months)
- Characteristics of patients treated with gefitinib for all patients and stratified by whether gefitinib discontinued treatment before or after three months(6 months)
- Description of treatment patterns in patients treated with gefitinib (prior chemo, treatment breaks, treatment on discontinuation)(6 months)
- Overall Survival (OS) in patients stratified by age, gender, stage and performance status.(6 months)
研究者
研究点 (12)
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