A Multi Centre Study to Compare Administration Schedules of G-CSF (Filgrastim) for Primary Prophylaxis of Chemotherapy-Induced Febrile Neutropenia in Early Stage Breast Cancer (REaCT-G2)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 324
- 试验地点
- 1
- 主要终点
- Febrile neutropenia
研究概览
简要总结
In patients with early-stage breast cancer, chemotherapy has substantially improved survival rates. Improvements in outcomes, however, are compromised by the considerable toxicities associated with chemotherapy, the most notable being neutropenia. Neutropenia is the presence of abnormally few white blood cells, leading to increase susceptibility to infection and can require hospitalization and need for intravenous antibiotics and is sometimes fatal. Febrile neutropenia (FN) can also be associated with treatment delays and dose reductions, potentially compromising treatment efficacy. Patients can receive medication to reduce the risk of FN such as Neupogen (filgrastim) as a daily injection for 5, 7 or 10 days. Since there is genuine uncertainty among healthcare professionals as to which administration schedule of Neupogen is the best for patients, the investigators are performing a randomized study for which patients will receive either 5, 7 or 10 days of Neupogen. Neupogen can cost approximately $200/injection, so if a physician prescribes 10 days for 8 cycles of treatment, this can cost $16,000 compared to a 5 day treatment which would cost half this. In addition to cost savings, many patients are not able to give themselves injections on a daily basis and require nursing resources which are utilized at high cost. This study will use an oral consent model to compare 5, 7 and 10 days of Neupogen to evaluate rates of febrile neutropenia and hospitalization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed primary breast cancer
- •Planned to start docetaxel component of FEC-D or AC-D, or first cycle of; dose-dense AC-T, TC, FEC-D or TAC chemotherapy
- •≥19 years of age
- •Able to provide verbal consent
排除标准
- •Contraindication to Filgrastim
研究组 & 干预措施
Neupogen for 5 days
Neupogen injection for 5 days
干预措施: Neupogen (Drug)
Neupogen for 7 days
Neupogen injection for 7 days
干预措施: Neupogen (Drug)
Neupogen for 10 days
Neupogen injection for 10 days
干预措施: Neupogen (Drug)
结局指标
主要结局
Febrile neutropenia
时间窗: 2 years
Number of participants with febrile neutropenia
Treatment-related hospitalization
时间窗: 2 years
Number of participants admitted to emergency for treatment-related reasons
次要结局
- Chemotherapy dose reduction(2 years)
- Chemotherapy discontinuation(2 years)
- Chemotherapy dose delay(2 years)
