The Evaluation of Lung Cancer Patient Treated With Epidermal Growth Factor Receptor Tyrosine Kinase
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
To evaluate Non-Small Cell Lung Cancer (NSCLC) patients clinical profile and the outcome after treatment with Gefitinib in Pulmonary Oncology Outpatient Clinic Dr. Soetomo General Hospital, Surabaya, Indonesia.
详细描述
Primary Objective: To determine the efficacy of Gefitinib in NSCLC patient harboring a positive EGFR mutation.
Secondary Objective: To evaluate the subjective response of NSCLC patients harboring a positive EGFR mutation who treated with Gefitinib.
Safety Objective: To evaluate the safety and tolerability of Gefitinib in NSCLC patient harboring a positive EGFR mutation.
研究设计
- 研究类型
- Observational
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 16 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •NSCLC based on histopathologic examination
- •Adenocarcinoma and/or nonadenocarcinoma based on histology examination
- •Clinical stadium stage IIIB and IV
- •Age 16-70 years old
- •Received gefitinib as therapy
- •At least completed 2 (two) data sets of RECIST 1.1 evaluations during the study period from January 2013 until July 2015
排除标准
- •Missing data of any variables of the treatment outcomes in the medical record
结局指标
主要结局
Overall Survival (OS)
时间窗: through study completion, in average of 1 year
Overall Survival (OS) as defined by the date of death certificate given by the attending physician or by other government officials
PFS (Progression Free Survival)
时间窗: through study completion, in average of 1 year
Progression Free Survival (PFS) as defined by RECIST 1.1 or attending physician's clinical judgement of clinical progression state
次要结局
未报告次要终点
研究者
Laksmi Wulandari, MD, PhD, FCCP
MD, PhD
Dr. Soetomo General Hospital