Bone Metastasis on the Survival of Gefitinib Effective Patients With Non-small Cell Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 265
- 主要终点
- Overal survival of patients
研究概览
简要总结
Gefitinib is a selective small molecule epidermal growth factor receptors (EGFR) tyrosine kinase inhibitors (EGFR-TKI), it's curative effect on non-small cell lung cancer (NSCLC) has been confirmed by a number of prospective clinical trials. The researches aim to analysis whether bone metastasis could affect the survival of NSCLC patients who were effective in Gefitinib treatment over 6 months.
详细描述
The epidermal growth factor receptors (EGFRs) have inhibitory effects on cell apoptosis, cell growth, angiogenesis and metastasis of tumor cell. The advent of EGFR-TKI significantly improved the clinical efficacy and safety of non-small cell lung cancer (NSCLC) treatment. Compelling study also demonstrate Gefitinib may be effective in the treatment of bone metastases. For NSCLC patients who were effective in EGFR-TKI treatment, whether bone metastasis would shorten the survival time of the patients or reduce the quality of life of patients is worth studying. The researches aim to analysis whether bone metastasis could affect the survival of NSCLC patients who were effective in Gefitinib treatment over 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •histological and (or) cytological diagnosed NSCLC patients.
- •patient was effective in Gefitinib treatment more than 6 months.
- •whether patient received chemotherapy and other treatment is not restricted.
- •whether patient was detected for EGFR gene mutation was not restricted.
排除标准
- •patient with small cell lung cancer.
- •patient without cytology or histopathology diagnosis results.
- •patient with bone metastases cannot rule out other reasons such as inflammation or trauma.
- •patient with poor treatment compliance.
- •patient with incomplete data.
研究组 & 干预措施
Gefitinib
Gefitinib is an selective small molecule epidermal growth factor receptors (EGFRs) tyrosine kinase inhibitors (EGFR-TKI) for non-small cell lung cancer.
干预措施: Gefitinib (Drug)
结局指标
主要结局
Overal survival of patients
时间窗: 5 years
The 5-year survival of NSCLC patients with or without bone metastasis
次要结局
- Survival of patients with both bone metastasis and brain metastasis(3 years)