NCT01000740已完成4 期
An International Expanded Access Clinical Programme With ZD1839 (IRESSATM) for Patients With Advanced Non-small Cell Lung Cancer (NSCLC) China Amendment 1: A Study on the Long Term Survivals in an Expand Access Program (EAP) of Iressa
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 59
- 试验地点
- 9
- 主要终点
- Describe the quality of life of long-term survivors who are not terminated from the EAP
研究概览
简要总结
The primary objective is to describe the quality of life of long-term survivors who are not terminated from the EAP.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of informed consent prior to any study specific procedures.
- •Participated in the Iressa EAP in China.
- •Diagnosed as NSCLC.
- •Patients who started EAP at least 3 years before this study initiated and have not yet terminated from the EAP (active long-term survivors).
- •Patients who consent to provide blood sample and available archival tumour tissue sample for EGFR gene testing (provision of tumour tissue sample is optional).
排除标准
- •Patients who disagree to participate this study.
- •Patients in whose medical objection was recorded to use the existing data from medical practice for scientific research.
研究组 & 干预措施
1
Experimental
Long term survivors who has been used IRESSA for more than 3 years and are still on gefitinib treatment
干预措施: EGFR Mutation Test (Genetic)
1
Experimental
Long term survivors who has been used IRESSA for more than 3 years and are still on gefitinib treatment
干预措施: Ki-67 protein expression (Genetic)
2
No Intervention
Long term survivors who has been used IRESSA for more than 3 years but have already terminated from EAP
3
No Intervention
Fast-progressors who defined as no more than 1 follow-up visit after recruitment with the reason of discontinuation being
结局指标
主要结局
Describe the quality of life of long-term survivors who are not terminated from the EAP
次要结局
- To describe the current tumour control status via RECIST
- To collect the risk factors related to prognosis in addition to the information already collected from EAP (age, gender, histology, smoking history, previous history of anti-cancer treatment, disease stage before starting gefitinib treatment, etc.)
- To describe the treatment compliance of gefitinib in these patients
- To describe the current clinical status of long-term survivors in the EAP program by clinical
- To compare the key clinical features (age group, gender, histology, smoking history, disease stage, treatment-naive or pre-treated, response to prior chemotherapy,) in fast-progressors versus long-term survivals.
研究者
研究点 (9)
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