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临床试验/NCT02816164
NCT02816164已完成4 期

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)

Ottawa Hospital Research Institute1 个研究点 分布在 1 个国家目标入组 324 人开始时间: 2016年9月最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

Neupogen injection for 5 days

干预措施: Neupogen (Drug)

Neupogen for 7 days

Active Comparator

Neupogen injection for 7 days

干预措施: Neupogen (Drug)

Neupogen for 10 days

Active Comparator

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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