Long-acting Granulocyte Colony Stimulating Factor for the Prevention of Febrile Neutropenia in Gynecologic Cancer Patients: A Prospective Cohort Study
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Incidence of febrile neutropenia
研究概览
简要总结
This study aims to analyze the effects of long-acting granulocyte colony stimulating factor (G-CSF) on the prevention febrile neutropenia (FN) in gynecologic cancer patients. Patients all accepted platinum-based chemotherapy 3-4 weeks once per course. The primary end is the incidence of FN in every course of chemotherapy. After the chemotherapy, patients accepted long-acting G-CSF and/or short-acting G-CSF. The secondary ends include: the incidences of myelosuppression, doses of G-CSF and its expenses, visits to outpatient and emergency clinics, adverse events related to G-CSF.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Confirmed primary gynecologic cancer
- •Good performance status
- •Aged 18 years or older
- •Signed an approved informed consents
- •No immunosuppressive disease
排除标准
- •Not meeting all of the inclusion criteria
研究组 & 干预措施
Long-acting G-CSF group
Patients in long-acting G-CSF group accept long-acting with or without short-acting G-CSF.
干预措施: Long-acting G-CSF (Drug)
Short-acting G-CSF group
Patients in long-acting G-CSF group only accept short-acting G-CSF.
干预措施: Short-acting G-CSF (Drug)
结局指标
主要结局
Incidence of febrile neutropenia
时间窗: One year
Incidence of febrile neutropenia in each course
次要结局
- Incidences of grade 3/4 myelosuppression(One year)
- Doses of G-CSF(One year)
- Times of visits to outpatient and emergency clinics(One year)
研究者
Lei Li
Professor
Peking Union Medical College Hospital