SPOG 2015 FN Definition. A Swiss Pediatric Oncology Group (SPOG) Initiated Multi-center Open-label Randomized Controlled Multiple Crossover Non-inferiority Trial on Safety of a High Versus Low Temperature Limit Defining Fever in Pediatric Patients With Cancer at Risk for Fever in Chemotherapy-induced Neutropenia (FN)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 269
- 试验地点
- 6
- 主要终点
- Rate of clinically defined FN with at least one safety relevant event
研究概览
简要总结
In a multi-center open-label cluster-randomized controlled parallel-group multiple crossover non-inferiority trial in children and adolescents up to 20 years diagnosed with cancer requiring chemotherapy, primarily the safety, and secondarily the efficacy and other endpoints, of a high (39.0°C) versus low (38.5°C) temperature limit defining fever (TLDF) for the diagnosis of fever in chemotherapy-induced neutropenia (FN) is studied. Safety is assessed by the rate of safety relevant events per chemotherapy exposure time, a composite endpoint including serious medical complications and bacteremia during FN. Patients are repeatedly randomized (cluster: study site) to the high or the low TLDF every month, resulting in possible multiple crossovers in one patient. The high TLDF is declared not to be inferior regarding safety compared to the low TLDF if non-inferiority of the rate ratio of safety relevant events is proven, with a single-sided non-inferiority margin of 1.33, applying mixed Poisson regression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chemotherapy treatment because of any malignancy for at least 2 months at time of recruitment for myelosuppressive therapy, or at least 1 cycle of myeloablative chemotherapy followed by autologous hematopoietic stem cell transplantation
- •Age ≥12 months and <18 years at time of recruitment
- •Written informed consent from patients and/or parents
排除标准
- •Infants <1 years old (reason: differences in temperature measurement method)
- •Past allogeneic hematopoietic stem cell transplantation
- •Denied written informed consent from patients and/or parents
研究组 & 干预措施
39.0°C temperature limit defining fever
Temperature limit defining fever, for definition of fever in neutropenia (FN), is single temperature >=39.0°C measured in the ear by infrared tympanic thermometry. If clinically indicated, the treating physician is allowed to make the diagnosis of FN at lower temperatures.
干预措施: 39.0°C temperature limit defining fever (Other)
38.5°C temperature limit defining fever
Temperature limit defining fever, for definition of fever in neutropenia (FN), is single temperature >=38.5°C measured in the ear by infrared tympanic thermometry. If clinically indicated, the treating physician is allowed to make the diagnosis of FN at lower temperatures.
干预措施: 38.5°C temperature limit defining fever (Other)
结局指标
主要结局
Rate of clinically defined FN with at least one safety relevant event
时间窗: 1 year (estimated average)
Poisson rate: number of clinically defined FN with at least one SRE divided by the entire chemotherapy exposure time for each patient, estimated to be 1 year on average (Unit: FN per year of chemotherapy exposure time) SRE: Composite endpoint (serious medical complication AND/OR bacteremia), reached until the end of each individual FN episode (Unit: binary)
次要结局
- Adverse events (B)(1 year (estimated average))
- Rate of FN diagnosed below TLDF (E)(1 year (estimated average))
- Delay from crossing low to high TLDF (C)(1 year (estimated average))
- Simultaneous and avoided FN diagnoses (G)(1 year (estimated average))
- Times and delays of diagnosis and therapy (A)(1 year (estimated average))
- Rate of clinically defined FN (D)(1 year (estimated average))
- Rate of FN diagnosed at/above TLDF (E)(1 year (estimated average))
- Duration of treatment (F)(1 year (estimated average))