NCT01268878已完成不适用
Hematologic Toxicity Observation of the TPF Medical Protocol. Description of the Impact of Febrile Neutropenia in Patients Who Receive the Chemotherapy of the TPF Medical Protocol in Head and Neck Cell Carcinoma
Groupe Oncologie Radiotherapie Tete et Cou16 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2010年6月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 130
- 试验地点
- 16
- 主要终点
- biologic blood counts
研究概览
简要总结
The ending of this study is to describe the effect of febrile neutropenia on patients who receive a chemotherapy by docetaxel+cisplatin+fluorouracil(TPF).
详细描述
In this study we will describe
- habits of medical staff in prescription of growth factors or antibiotic prophylaxis
- ratio of patients treated by growth factors in primary or secondary prophylaxis
- ratio of patients treated in primary prophylaxis who present a febrile neutropenia
- ratio of patients who need to be hospitalized and the duration of those hospitalizations.
- causes of lateness, of decreasing, and of stop of chemotherapy
- antibiotic and growth factors prophylaxis tolerance .
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •patients with histologically proved head and neck squamous cell carcinoma
- •age: more than 18
- •patients who are beginning a chemotherapy (docetaxel+cisplatin+ 5FU)
- •patients must have been informed of automatic data processing concerning them.
排除标准
- •previous chemotherapy for the head and neck squamous cell carcinoma
- •previous chemotherapy for an other cancer in the two years before
- •intercurrent illness that could significantly interfere with chemotherapy such as HIV infection, infection or active febrile illness, a chronic intestinal disease
结局指标
主要结局
biologic blood counts
时间窗: blood test before every chemotherapy up to 4 months
evaluation of medical status evaluation of hematologic toxicity description of clinic toxicity: fever, sepsis..
次要结局
未报告次要终点
研究者
研究点 (16)
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