A Phase II Randomized Trial of Gemcitabine/Cisplatin Versus Gemcitabine/Epirubicin in Stage IIIB/IV Non-Small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 2
- 主要终点
- The primary objective of this study is to explore efficacy of gemcitabine and epirubicin in the treatment of NSCLC patients who need palliative chemotherapy.
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of gemcitabine/cisplatin versus gemcitabine/epirubicin in Stage IIIB/IV NSCLC in terms of response rate and overall survival.
详细描述
Most patients suffered from nausea, vomiting and prolonged anorexia after cisplatin treatment. Epirubicin is an anthracycline that was used widely in the treatment of cancer. Our previous study of an epirubicin and paclitaxel combination in non-small cell lung cancer patients showed a response rate of 52.6% and good median survival. However, most patients suffered from paclitaxel-related neurotoxicity.
Chemotherapy may increase an average of 1 to 2 months of median survival in inoperable non-small cell lung cancer patients treated with chemotherapy. However, chemotherapy may not provide a cure for these patients. Reduction of side effects and enhancement of life quality of the patients are as important as life prolongation for these patients. We designed a combination chemotherapy using gemcitabine with epirubicin in the treatment of inoperable non-small cell lung cancer. The treatment will be compared to gemcitabine and cisplatin combination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Histologic or cytologic diagnosis of stage IIIB/IV NSCLC
- •No prior chemotherapy
- •Age > 18 years
- •ECOG score < 0 to 2
- •Bi-dimensionally measurable lesions
- •WBC > 4,000/ml, ANC > 1,500/ml, platelets>100,000/ml
- •Hb>10g/dl.
- •ALT/AST < 5 times x UNL, bilirubin < 1.5times x UNL, creatinine < 1.25 times x UNL, normal calcium level
- •Life expectancy > 12 weeks
排除标准
- •CNS metastases, Concomitant myelosuppressive radiotherapy, C/T, hormonal therapy or immunotherapy.
- •Active congestive heart failure, angina and/or arrhythmia requiring therapy or previous myocardial infarction
结局指标
主要结局
The primary objective of this study is to explore efficacy of gemcitabine and epirubicin in the treatment of NSCLC patients who need palliative chemotherapy.
次要结局
- The secondary objective of this study is to compare efficacy (response rate，overall survival) of gemcitabine/epirubicin to gemcitabine/cisplatin in the treatment of inoperable NSCLC.