NCT00875004终止不适用
Research Factors Predictive of Treatment Failure With Erythropoietin Beta (NeoRecormon®) in Patients With Solid Tumors Treated With Chemotherapy
Institut du Cancer de Montpellier - Val d'Aurelle1 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2007年12月7日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Treatment failure (changes in hemoglobin levels)
研究概览
简要总结
RATIONALE: Epoetin beta may cause the body to make more red blood cells and may prevent or reduce side effects in patients undergoing chemotherapy for solid tumors.
PURPOSE: This clinical trial is studying how well epoetin beta works in patients undergoing chemotherapy for solid tumors.
详细描述
OBJECTIVES:
Primary
- Identify factors predictive of treatment failure in patients with solid tumors treated with epoetin beta while undergoing chemotherapy.
Secondary
- Evaluate the impact of achieving target hemoglobin levels (i.e., hemoglobin > 11 g/dL) after 8 weeks of treatment with epoetin beta.
- Evaluate changes in hemoglobin levels from baseline to after 8 weeks of treatment with epoetin beta.
- Evaluate the tolerability of epoetin beta in these patients.
- Evaluate the quality of life of these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Erythropoietin beta
Experimental
干预措施: epoetin beta (Biological)
Erythropoietin beta
Experimental
干预措施: systemic chemotherapy (Drug)
Erythropoietin beta
Experimental
干预措施: quality-of-life assessment (Procedure)
结局指标
主要结局
Treatment failure (changes in hemoglobin levels)
时间窗: From date of randomization until the week 8
The 8th week of treatment assessment defines the patient on erythropoeitine beta (NeoRecormon®) treatment for failure or success
次要结局
未报告次要终点
研究者
研究点 (1)
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