Single Agent Chemotherapy With Weekly Docetaxel vs Combination Chemotherapy in Second-line Treatment of Advanced Non Small Cell Lung Cancer
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 84
- 试验地点
- 24
- 主要终点
- overall survival
研究概览
简要总结
The purpose of this study is to compare the overall survival of patients with advanced non small cell lung cancer treated with docetaxel as single therapy versus docetaxel in combination with either gemcitabine or vinorelbine or in combination with capecitabine.
详细描述
This study is for patients with previously diagnosed advanced non small cell lung cancer (NSCLC, stage IIIb or IV) who had progression of their disease during or after first-line therapy containing platinum. Patients will be assigned to receive 6 cycles of therapy from one of four treatment regimens:
- docetaxel
- docetaxel + vinorelbine
- docetaxel + gemcitabine
- docetaxel + capecitabine
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
- — 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent
- •Age > 18
- •Histological diagnosis of non small-cell lung cancer (NSCLC)
- •Stage IIIb or Stage IV disease (in IIIb, previous treatment with chemotherapy + radiotherapy, or metastatic supraclavicular lymph nodes or pleural effusion)
- •Disease in progression
- •Previous chemotherapy with platinum-derivative (and with > 21 days from last administration)
排除标准
- •ECOG performance status > 2
- •Age > 75 years
- •History of malignant neoplasm within the previous 5 years (except for baso- or spino-cellular skin carcinoma and in-situ carcinoma of the uterine cervix, provided they are being adequately treated)
- •Previous treatment with docetaxel
- •Presence of symptomatic cerebral metastasis
- •Neutrophils < 2.0 x 109/l, platelets < 100,000/l, hemoglobin > 10g/dl
- •Bilirubin < 1.5 x the upper normal limit
- •SGOT , SGPT, or bilirubin > 1.25 x the upper normal limits except in the presence of hepatic metastasis
- •Creatinine >1.25 x the upper normal limit
- •Any concomitant pathology that would, in the Investigator's opinion, contraindicate the use of the drugs in the protocol
- •Inability to comply with follow up
- •Pregnant or nursing females
研究组 & 干预措施
docetaxel
single agent docetaxel
干预措施: docetaxel (Drug)
docetaxel + vinorelbine OR gemcitabine
docetaxel in combination with either vinorelbine or with gemcitabine
干预措施: docetaxel (Drug)
docetaxel + vinorelbine OR gemcitabine
docetaxel in combination with either vinorelbine or with gemcitabine
干预措施: vinorelbine (Drug)
docetaxel + vinorelbine OR gemcitabine
docetaxel in combination with either vinorelbine or with gemcitabine
干预措施: gemcitabine (Drug)
docetaxel + capecitabine
docetaxel in combination with capecitabine
干预措施: docetaxel (Drug)
docetaxel + capecitabine
docetaxel in combination with capecitabine
干预措施: capecitabine (Drug)
结局指标
主要结局
overall survival
时间窗: one year
次要结局
未报告次要终点