NCT00210002终止2 期
Evaluation of Systematic Intravenous Iron Supplementation During Darbepoetin Alfa Treatment in Prophylaxis of Severe Anaemia Chemo-Induced.
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 55
- 试验地点
- 4
- 主要终点
- Biological response rate for each group.
研究概览
简要总结
The purpose of this study is to evaluate the response rate obtained in an heterogeneous oncologic population treated by chemotherapy, and either by Darbepoetin alfa classic treatment or by association of Darbepoetin alfa -ferric saccharose systematic supplementation, administered concomitantly with chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Age ≥ 18 years
- •Well-informed written consent, signed by the patient
- •Patient picked up for solid tumor treatment, whichever the localization, with or without metastasis
- •Patient revealing, before or during chemotherapy, a moderate anemia, that means: Men: 9<Hb<12 g/dl; Women: 9<Hb<11 g/dl.
- •Patient for who at least four chemotherapy cycles are planed (eight in case of weekly chemotherapy) after inclusion in the study
- •Patients with life expectancy higher than three months
- •Patient with general conditions compatible with the study's follow-up
排除标准
- •Contra-indication for Venofer
- •Anemia which can have curative treatment
- •Bloody transfusion during the previous four weeks
- •Documented or suspected medullary invasion
- •Uncontrolled arterial hypertension
- •Acute bacterial infection
- •Transferrin saturation's coefficient
- •Pregnancy
- •Ferric salts oral treatment interrupted since less than one week
- •Patient with bad french language's comprehension
- •Patient with a major psychiatric pathology
- •Patient under guardianship, trusteeship or justice safeguard
结局指标
主要结局
Biological response rate for each group.
次要结局
- To determine tolerance for ferric saccharose (Venofer®)
- To determine percentage of patients who necessitate an increase of Darbepoetin alfa's dose(Aranesp®)
- To determine percentage of hemoglobin rate's correction
- To determine biological parameters's evolution
研究者
研究点 (4)
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