Impact on Survival of Cutaneous Reactions in Erlotinib Plus Gemcitabine Treated Patients With Metastatic Pancreatic Cancer Under Conditions of Daily Routine Practice
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 338
- 试验地点
- 1
- 主要终点
- Overall Survival Stratified by Rash
研究概览
简要总结
This observational study will evaluate the impact of rash on survival of patients with metastatic pancreatic cancer treated with erlotinib plus gemcitabine. Further, clinical effectiveness, efficacy and safety will be assessed. Data will be collected for 12 months.
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
- •Adults, age >= 18 years
- •Patients with metastatic pancreatic cancer where investigators have decided to give combination therapy of erlotinib and gemcitabine according to Summary of Product Characteristics (SmPC)
排除标准
- •Contraindications for erlotinib according to Summary of Products Characteristics (SmPC)
研究组 & 干预措施
Erlotinib plus Gemcitabine
Patients with metastatic pancreatic cancer, who were planned to receive combination therapy of erlotinib and gemcitabine based on the investigator's assessment.
干预措施: erlotinib (Drug)
Erlotinib plus Gemcitabine
Patients with metastatic pancreatic cancer, who were planned to receive combination therapy of erlotinib and gemcitabine based on the investigator's assessment.
干预措施: gemcitabine (Drug)
结局指标
主要结局
Overall Survival Stratified by Rash
时间窗: Up to 12 months
Overall survival was defined as the time from the date of randomization to the date of death from any cause and was stratified by rash status. Participants with rash: rash = yes. Participants without rash: rash = no.
次要结局
- Number of Participants With Rash by Severity(Up to 12 months)
- Number of Participants With Adverse Events (AEs)(Up to 12 months)
- Number of Dose Modifications and Dose Withdrawals of Erlotinib(Up to 12 months)
- Number of Dose Modifications and Dose Withdrawals of Gemcitabine(Up to 12 months)
- Time of Onset of Rash After Start Erlotinib Treatment(Up to 12 months)
- Overall Survival Time Stratified by Eastern Cooperative Oncology Group Performance Status (ECOG-PS)(Up to 12 months)
- Percentage of Participants With Best Overall Response(Up to 12 months)
- Time to Disease Progression(Up to 12 months)
- Score in Patient Questionnaire: Possible Side Effects(At Weeks 4, 8, 9 and 16)
- Score in Participant Questionnaire: What to Do in Case of Side Effect(At Weeks 4, 8, 9 and 16)
- Score in Participant Questionnaire: Actual Side Effects of Therapy Compared to Expectation(At Weeks 4, 8, 9 and 16)
- Score in Participant Questionnaire: Quality of Life(At Weeks 4, 8, 9 and 16)