NCT01535729已完成不适用
Erlotinib (Tarceva®) in Routine Clinical Practice in Patients With Advanced Non Small Cell Lung Cancer (NSCLC) After Failure of at Least One Prior Chemotherapy Regimen With Focus on the Elderly Patient.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 465
- 主要终点
- Percentage of Participants Who Were Alive 1 Year After Start of Treatment
研究概览
简要总结
This prospective observational study will evaluate the efficacy and safety of Tarceva (erlotinib) in elderly patients with advanced non-small cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen. Data of patients treated with Tarceva in routine clinical practice will be collected for 1 year.
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients, > 65 years of age
- •Locally advanced or metastatic non-small cell lung cancer (Stage IIIb or IV)
- •Failure of at least one prior standard platinum-based chemotherapy
排除标准
- •Age < 65 years
结局指标
主要结局
Percentage of Participants Who Were Alive 1 Year After Start of Treatment
时间窗: Year 1
Overall survival was defined as the time from the date of first medication to the date of death from any cause. If death was not observed during the study, survival time was censored at the last day of observation (latest at the end of study after one year). Overall percentage of participants who were alive 1 year after study treatment and those based on the factor of age (65-69, 70-74, 75-79, ≥ 80 years) were reported.
次要结局
- Median Overall Survival: Age(From Baseline then every 3 months from Month 3 until death (Maximum follow-up to Month 40))
- Percentage of Participants With Rash(Months 3, 6, 9, 12)
- Percentage of Participants With Diarrhea(Months 3, 6, 9, 12)
- Percentage of Participants With Rash Based on Severity During the Course of Time(Months 3, 6, 9, 12)
- Percentage of Participants With Fatigue(Months 3, 6, 9, 12)
- Percentage of Participants With Diarrhea Based on Severity During the Course of Time(Months 3, 6, 9, 12)
- Percentage of Participants With Fatigue Based on Severity During the Course of Time(Months 3, 6, 9, 12)
- Percentage of Participants With Dose Modifications by Reason(Months 3, 6, 9, 12)
- Percentage of Participants With Dose Withdrawals by Reason(Months 3, 6, 9, 12)
- Percentage of Participants With Cough by Severity(Baseline, Months 3, 6, 9, 12)
- Percentage of Participants With Dyspnea by Severity(Baseline, Months 3, 6, 9, 12)
- Percentage of Participants With Complete Response (CR), Partial Response (PR) and Stable Disease (SD)(Months 3, 6, 9, 12)
- Time to Start of Erlotinib Therapy After End of First Line Therapy(Baseline)
- Percentage of Participants With Remission of CR and PR(Months 3, 6, 9, 12)
- Median Progression Free Survival: Overall(From Baseline then every 3 months from Month 3 until disease progression (Maximum follow-up to Month 40))
- Median Progression Free Survival: Age(From Baseline then every 3 months from Month 3 until disease progression (Maximum follow-up to Month 40))
- Median Progression Free Survival: Gender(From Baseline then every 3 months from Month 3 until disease progression (Maximum follow-up to Month 40))
- Median Progression Free Survival: Smoking Status(From Baseline then every 3 months from Month 3 until disease progression (Maximum follow-up to Month 40))
- Median Progression Free Survival: Best Response to Prior Chemotherapy(From Baseline then every 3 months from Month 3 until disease progression (Maximum follow-up to Month 40))
- Median Overall Survival: Smoking Status(From Baseline then every 3 months from Month 3 until death (Maximum follow-up to Month 40))
- Median Overall Survival: Best Response to Prior Chemotherapy(From Baseline then every 3 months from Month 3 until death (Maximum follow-up to Month 40))
- Median Overall Survival: Overall(From Baseline then every 3 months from Month 3 until death (Maximum follow-up to Month 40))
- Median Overall Survival: Gender(From Baseline then every 3 months from Month 3 until death (Maximum follow-up to Month 40))
研究者
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