NCT02607592Unknown3 期
Nedaplatin or Cisplatin Combined With Pemetrexed in the First Line Treatment of Advanced Adenocarcinoma：A Prospective Multi-center Phase III Randomized Controlled Trial
Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 293 人开始时间: 2015年8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
- 293
- 试验地点
- 1
- 主要终点
- progression free-survival（PFS）
研究概览
简要总结
The purpose of this study is to investigate the PFS, ORR, OS and overall toxicity value（OTV）on advanced adenocarcinoma treated with nedaplatin or cisplatin combined with pemetrexed.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient who was confirmed primary adenocarcinoma by pathologic histology or cytology
- •The TNM staging system according to IASLC2009 was stageIV or those stageIIIB who were not fit for operation or radiotherapy
- •Including one available evaluation lesion at least according to RECIST criteria
- •Adult patients (≥18 years and ≤75 years). ECOG Performance Status 0 or 1 .Life expectancy of at least 12 weeks.Haemoglobin ≥90g/dl, Absolute neutrophil count (ANC)≥ 2x 109/L, platelets ≥100 x 109/L. Total bilirubin ≤upper limit of normal (ULN). ALT and AST ≤ 2.5 x ULN. Creatinine clearance ≥60ml/min (calculated according to Cockcroft-gault formula).
- •Patients who had never received any antineoplastic therapy
排除标准
- •Patient who has another cancer in recent 5 years,not including basal cell carcinoma or cervical carcinoma in situ
- •Patient with brain metastases whose intracranial pressure symptoms can not control by using glucocorticoid or mannitol
- •Previous radiotherapy（Palliative radiotherapy in order to pain management can be excluded）
- •Patient who has used chemotherapy before(bisphosphonate can be excluded )
- •Serious uncontrolled systemic disease including active infection,uncontrolled hypertension,diabetes,unstable angina,congestive heart failure,myocardial infarction,severe arrhythmia which needs drugs,hepatic、renal and metabolic disease
- •Patient who is allergic to drugs we need to use
- •Patients who are in pregnancy or lactation
- •AST or ALT 》2.5 * upper limit of normal (ULN)，and ALP》5*ULN
研究组 & 干预措施
Nedaplatin and Pemetrexed
Experimental
nedaplatin 90mg/m2 d1+pemetrexed 500mg/m2 d1 （Every three weeks for a treatment cycle）
干预措施: nedaplatin+pemetrexed (Drug)
Cisplatin and Pemetrexed
Active Comparator
cisplatin 25mg/m2 d1-3+pemetrexed 500mg/m2 d1 （Every three weeks for a treatment cycle）
干预措施: cisplatin and pemetrexed (Drug)
结局指标
主要结局
progression free-survival（PFS）
时间窗: 12months
Progression-free survival is defined as the time from the starting date of study drug to the date of first documentation of disease progression or death, whichever occurs first
次要结局
- overall survival（OS）(24 months)
- overall toxicity value(12 months)
- objective response rate （ORR）(12months)
- Progression-Free Survival (PFS) rate at 18 weeks(20 weeks)
研究者
Li-kun Chen
associate professor
Sun Yat-sen University
研究点 (1)
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