NCT00940069已完成2 期
A Multicenter, Open Clinical Trial of Using TS Gene Polymorphism to Predict Effect in Patients of Advanced Lung Adenocarcinoma to Pemetrexed Combining With Cisplatin Regiment as First-line Treatment
Hunan Province Tumor Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2009年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- time to progress
研究概览
简要总结
The investigators performed a multicenter, open trial of using TS gene polymorphism to predict advanced lung adenocarcinoma effect to pemetrexed combined with cisplatin regiment as first-line treatment.
详细描述
- Main eligibility criteria were histologic or cytologic proof of advanced non-small-cell lung cancer (NSCLC) primary treatment, normal organ function, and Eastern Cooperative Oncology Group performance status 0 to 2.
- All Patients were delivered to pemetrexed 500 mg/m2 and cisplatin 75 mg/m2 for not less than 4 cycle, administered intravenously every 3 weeks. Response assessment was performed every 6 weeks; toxicity assessment was performed every 3 weeks.
- Primary end point was time to progression (TTP); secondary end points were objective response rate (ORR), overall survival (OS), and toxicity.
- The study was designed to evaluate TS(thymidylate synthase) gene polymorphism as a predictor for advanced lung adenocarcinoma effect to pemetrexed combined with cisplatin regiment as first-line treatment.
- Polymorphisms of thymidylate synthase were investigated in peripheral WBC（white blood cell）of all patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •histologic or cytologic proof of advanced lung adenocarcinoma
- •primary treatment
- •normal organ function
- •Eastern Cooperative Oncology Group performance status 0 to 2
排除标准
- •Symptomatic patients with brain metastases
- •Major organ dysfunction and severe heart disease
研究组 & 干预措施
TS high expression genotype
Experimental
TS high expression genotype delivered to pemetrexed 500 mg/m2 and cisplatin 75 mg/m2,for not less than 4 cycle, administered intravenously every 3 weeks.
干预措施: pemetrexed (Drug)
TS low expression genotype
Experimental
TS low expression genotype delivered to pemetrexed 500 mg/m2 and cisplatin 75 mg/m2,for not less than 4 cycle, administered intravenously every 3 weeks.
干预措施: pemetrexed (Drug)
结局指标
主要结局
time to progress
时间窗: 6 months
次要结局
- overall survival(1 year)
研究者
Yi Luo
director
Hunan Province Tumor Hospital
研究点 (1)
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