NCT01799421已完成不适用
Predictive Models of Risk Assessment of Febrile Neutropenia and Grade 3-4 Neutropenia in Patients With Non-hematological Cancer Treated With Conventional Chemotherapy.
Asociación para el Fomento de la Investigación y el Desarrollo Integral de la Oncología20 个研究点 分布在 1 个国家目标入组 420 人开始时间: 2011年10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
- 420
- 试验地点
- 20
- 主要终点
- Identify predictive models about the risk of febrile neutropenia and neutropenia grade 3/4 in patients with non-hematologic cancer
研究概览
简要总结
The purpose of this study is to identify prognostic factors and to develop predictive models of risk of febrile neutropenia and neutropenia grade 3/4 in patients with solid tumors receiving chemotherapy with schemas that have an inherent risk of febrile neutropenia of 10-20%.
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
- •Male or female > 18 years
- •Histologically confirmed solid tumor.
- •Subjects who have not received chemotherapy and / or radiotherapy in the last 3 months.
- •Subject to initiate a chemotherapy (ie, cycle 1, day 1)
- •The chemotherapy regimen should have an inherent risk of febrile neutropenia of 10-20%.
- •Planning a minimum of 3 cycles chemotherapy.
- •Adequate bone marrow reserve defined by: leukocytes ≥ 3,000 / mm3, platelets ≥ 100.000/mm3; neutrophils ≥ 1,500 / mm
- •Adequate hepatic and renal function, defined by: bilirubin <1.5 times the normal value, ALT and AST <3 times the normal range (both can be elevated up to 5 times the normal value in patients with known liver metastases); creatinine <1.5 times upper normal value
- •Informed consent
排除标准
- •Patients under treatment with an investigational treatment.
- •Active infection in the last 72 h before starting chemotherapy.
- •Indication of chemotherapy dose intensity or chemotherapy included in the risk rating of febrile neutropenia <10% or >20%.
- •Patients with concomitant chemoradiotherapy.
- •Patients being treated with biological drugs in monotherapy.
- •Any other condition causing neutropenia.
- •History of bone marrow transplant or stem cells.
结局指标
主要结局
Identify predictive models about the risk of febrile neutropenia and neutropenia grade 3/4 in patients with non-hematologic cancer
时间窗: 6 months
次要结局
- Analyze costs to treat febrile neutropenia and neutropenia grade 3/4(6 months)
- Evaluate impact of febrile neutropenia and neutropenia grade 3/4 in treatment compliance(6 months)
- Occurrence of serious adverse events(6 months)
- Analyze the risk of mortality due to febrile neutropenia and neutropenia grade 3/4 during the chemotherapy treatment(6 months)
研究者
研究点 (20)
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