NCT00770172已完成3 期
Moderate Persistent Neutropenia: Comparison of Administration of G-CSF (Granulocyte Colony Stimulating Factor) 1 Day Out of 2 Versus Traditional Schedules to Maintain Dose Intensity. Phase III Multicenter Study in Patients With Solid Tumors Receiving Chemotherapy
Centre Francois Baclesse2 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2007年10月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Number of courses of G-CSF required
研究概览
简要总结
RATIONALE: Colony-stimulating factors, such as G-CSF, may increase the number of white blood cells found in bone marrow or peripheral blood and may prevent persistent neutropenia in patients receiving chemotherapy. It is not yet known which regimen of G-CSF may be more effective in preventing neutropenia.
PURPOSE: This randomized phase III trial is comparing two different regimens of G-CSF to see how well it works in preventing persistent neutropenia in patients with solid tumors who are receiving chemotherapy.
详细描述
OBJECTIVES:
Primary
- Determine the efficacy of filgrastim (G-CSF) in preventing persistent moderate neutropenia in patients with solid tumors while maintaining chemotherapy courses.
Secondary
- Compare the tolerability of 2 regimens of G-CSF in these patients.
- Determine the number of courses of G-CSF needed in each regimen.
- Evaluate the frequency of infections.
- Determine dose intensity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Supportive Care
- 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 solid tumor
- •Receiving chemotherapy in any line of treatment (adjuvant or metastatic)
- •Chemotherapy courses repeating every 21 days or beginning on day 8 allowed
- •Received at least 2 prior courses of chemotherapy
- •Moderate neutropenia (grade 1-3) leading to a delay of the first course by ≥ 7 days or a delay of the second course of treatment
- •PATIENT CHARACTERISTICS:
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •No known hypersensitivity to filgrastim (G-CSF) or any of its components
- •No severe immunodepression
- •No malignant hematological disease
- •No history of psychiatric illness
- •No patients deprived of liberty or under guardianship
- •No psychological, familial, social, or geographical reasons preventing follow-up
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
排除标准
- 未提供
结局指标
主要结局
Number of courses of G-CSF required
次要结局
未报告次要终点
研究者
研究点 (2)
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