NCT00274885Unknown4 期
Study of the Relationship Between the Rate of Residual Platinum in the Blood and the Incidence of Persistent Neurotoxicity in Patients Treated for Gastrointestinal Cancer With Oxaliplatin
GERCOR - Multidisciplinary Oncology Cooperative Group12 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2005年10月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 58
- 试验地点
- 12
- 主要终点
- Relationship between residual platinum levels in the blood and persistent neurotoxicity
研究概览
简要总结
RATIONALE: Learning about the relationship between platinum levels in the blood and neurotoxicity in patients receiving oxaliplatin may help plan treatment and may help patients live more comfortably.
PURPOSE: This phase IV trial is studying the relationship between platinum levels in the blood and neurotoxicity in patients who are receiving oxaliplatin for gastrointestinal cancer.
详细描述
OBJECTIVES:
Primary
- Determine the relationship between residual platinum levels in the blood and persistent neurotoxicity in patients receiving oxaliplatin for gastrointestinal cancer.
Secondary
- Determine the pharmacokinetics of oxaliplatin in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of gastrointestinal cancer
- •Receiving or planning to receive 8 months of oxaliplatin-based chemotherapy
- •No pre-existing neuropathy
- •No CNS disease or cerebral metastases
- •PATIENT CHARACTERISTICS:
- •Life expectancy ≥ 12 weeks
- •No biliary or gastro-duodenal obstruction
- •No familial, social, geographical, or psychological condition that would preclude study treatment
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •No other concurrent drug or agent that is potentially neurotoxic
排除标准
- 未提供
结局指标
主要结局
Relationship between residual platinum levels in the blood and persistent neurotoxicity
次要结局
- Pharmacokinetics
研究者
研究点 (12)
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