NCT00657423Unknown3 期
Study of Endostar Combined With Docetaxel and Cisplatin on the Angiogenesis of Advanced Non-small Cell Lung Cancer
Xijing Hospital1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2008年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- mean survival time
研究概览
简要总结
To study the impact of endostar combined with docetaxel and cisplatin on the angiogenesis of non-small cell lung cancer, patients will be randomly assigned to the group one (endostar combined with docetaxel and cisplatin) and group two (docetaxel and cisplatin).
- The serum concentrations of Endostatin,VEGF and bFGF are determined.
- Blood circulating endothelial cells (CECs) and circulating hematopoietic progenitor cells (CPCs) will be measured by flow cytometer.
- Statistical analysis will be applied to study the relationship between the levels of Endostatin, VEGF, bFGF, CECs and CPCs and the clinical outcomes such as objective response rate(ORT), time to progression (TTP), mean survival time(MST), toxicity and quality of life (QOL).
详细描述
To study the impact of endostar combined with docetaxel and cisplatin on the angiogenesis of non-small cell lung cancer,patients will be randomly assigned to the experimental group(endostar combined with docetaxel and cisplatin) and the control group (docetaxel and cisplatin).
- the serum concentrations of Endostatin,VEGF and bFGF are determined.
- Blood circulating endothelial cells (CECs) and circulating hematopoietic progenitor cells (CPCs) will be measured by flow cytometer.
- the clinical parameters such as objective response rate (ORT),time to progression(TTP) and mean survival time(MST) will be collected according to the WHO criteria.
- the toxicity will be recorded according to the NCI-CTC v3.0.
- the Quality of life was self-assessed using the European Organisation for Research and Treatment of Cancer (EORTC) QLQ C-30 questionnaire.
- Statistical analysis will be applied to study the relationship between the levels of Endostatin,VEGF,bFGF,CECs and CPCs and the clinical outcomes such as ORT, TTP, MST, toxicity and QOL.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Clinical diagnosis of advanced or metastatic NSCLC (confirmed histologically, with a tumor that was measurable by clinical and/or radiologic examination.
- •Have an Eastern Cooperative Oncology Group performance status 0 to
- •Adequate renal, cardiac, hepatic, and hematologic function as indicated by the following parameters: absolute neutrophil count 2 x the ninth power of ten/L, thrombocytes 100 x the ninth power of ten/L, hemoglobin 10 g/dL, total bilirubin 1.25x the upper limit of normal range (ULN), ALT and AST 1.5x ULN, alkaline phosphatase 5x ULN, creatinine 1.15x ULN.
排除标准
- •Known brain metastases or secondary neoplasia.
- •Myocardial insufficiency or myocardial infarction within the preceding 6 months.
- •Severe renal or hepatic insufficiency.
- •Pre-existing motor or sensor neurotoxicity WHO grade
- •Severe psychologic disease.
- •Active infection, or other condition that could compromise protocol compliance.
- •Simultaneous administration of other antineoplastic medications.
- •Clinically significant hemoptysis.
- •Pregnancy and/or lactation.
研究组 & 干预措施
1
Experimental
干预措施: Treated by endostar combined with docetaxel and cisplatin (Drug)
2
Active Comparator
干预措施: Treated by docetaxel and cisplatin (Drug)
结局指标
主要结局
mean survival time
时间窗: 1 year
次要结局
- objective response rate(1 year)
研究者
研究点 (1)
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