NCT01860508Unknown不适用
Advanced Metastatic Non-small Cell Lung Cancer Patients Aged or PS Score 2 Points for First Line Application Pemetrexed/Carboplatin Chemotherapy Regimens Sequential Pemetrexed Single Drug Maintenance Treatment of Clinical Research and Related Predictive Biomarkers of Exploratory Research
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- PFS
研究概览
简要总结
PFS
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
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •.≥65 years or PS 2
- •Patients who were diagnosed by the histologic, cytologic diagnosis of IV non-small cell lung cancer
- •Patients received no chemical therapy or only received targeted therapy,and there is evidence show the patent is PD
- •Presence of at least one index lesion measurable by CT scan or MRI
- •leucocyte ≥ 3.5×109/L
- •neutrophil ≥ 1.5×109/L
- •platelet ≥ 80×109/L
- •Hemoglobin ≥ 9g/L
- •ALT and AST ≤ 2.5×ULN ,Tbil≤ 1.5×ULN
- •BUN≤ 1.5×ULN
- •Signed written informed consent
排除标准
- •squamous carcinoma or small cell lung cancer
- •Patients were allergic to pemetrexed
- •Patients received chemotherapy before
- •Uncontrolled acute infection
- •.Uncontrolled pleural effusion
- •Severe symptomatic heart disease
- •Severe infection or metabolic disfunction
- •Patients with other malignant tumor
- •Uncontrolled brain metastases
- •Patients have accepted other clinical trials
- •Female patients during their pregnant and lactation period, or patients without contraception
- •Mental disorientation of disorder
- •Glucocorticoids taboo
研究组 & 干预措施
pemetrexed
Experimental
干预措施: pemetrexed /carboplatin (Drug)
结局指标
主要结局
PFS
时间窗: from the first cycle of treatment (day one) to two month after the last cycle
次要结局
未报告次要终点
研究者
Jialei Wang
Attending doctor of medical oncology
Fudan University
研究点 (1)
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