NCT00259402已完成2 期
Phase II Open-label Single Arm Study of Oxaliplatin Combined With Cisplatin and 5FU in Advanced Esophagus Cancer Patients
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
- Sanofi
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Efficacy endpoints include tumor response, progression free and overall survival.
研究概览
简要总结
- To determine the activity and efficacy of the schema specified as dose regimen
- To determine the safety and tolerability of the oxaliplatin-cisplatin and 5FU
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
- •Patients with histologically proven epidermoid carcinoma or adenocarcinoma of esophagus or stomach, with unresectable or metastatic disease;
- •No previous treatment with chemotherapy or radiotherapy
- •Measurable lesion (uni or bidimensional)
排除标准
- •Creatinin clearance <50 mL/min
- •Total bilirubin >1.5*ULN (Upper Limit of Normal)
- •AST/ALT > 2.5*ULN
- •Total White Blood Cell <1.500.000/mL
- •Platelet count <100.000.000/mL
- •symptomatic sensitive peripheral neuropathy
- •pregnant or breast-feeding women
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
Oxaliplatin
Experimental
干预措施: Oxaliplatin + cisplatin + 5-Fluorouracil (5-FU) (Drug)
结局指标
主要结局
Efficacy endpoints include tumor response, progression free and overall survival.
时间窗: Throughout the whole study
次要结局
- Safety endpoints include summary of adverse events assessed by history, physical exams and laboratory evaluations.(Throughout the whole study duration)
研究者
研究点 (1)
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