Long-acting Granulocyte Colony Stimulating Factor for the Prevention Febrile Neutropenia in Epithelial Ovarian Cancer: A Phase 3 Randomized Control Study
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 556
- 试验地点
- 1
- 主要终点
- 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 epithelial ovarian cancer. Patients are randomized into study group and control group. In study group, patients accept long-acting G-CSF 48 hours from the chemotherapy. While the control group accept regular treatment rather than long-acting G-CSF. The primary end is the incidence of FN in every course of chemotherapy. 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
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •Willing to accepted debulking surgeries and adjuvant chemotherapy
- •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
Study group
Patients in study group accept long-acting granulocyte colony stimulating factor 48 hours from the chemotherapy and regular interventions for myelosuppression.
干预措施: long-acting granulocyte colony stimulating factor (Drug)
Study group
Patients in study group accept long-acting granulocyte colony stimulating factor 48 hours from the chemotherapy and regular interventions for myelosuppression.
干预措施: Short-term granulocyte colony stimulating factor (Drug)
Control group
Patients in control group only accept regular interventions for myelosuppression rather than long-acting granulocyte colony stimulating factor.
干预措施: Short-term granulocyte colony stimulating factor (Drug)
结局指标
主要结局
febrile neutropenia
时间窗: One year
the incidence of febrile neutropenia happened during each course of chemotherapy
次要结局
- myelosuppression(One year)
- adverse events(One year)
- doses of granulocyte colony stimulating factor(One year)
- expenses of granulocyte colony stimulating factor(One year)
- progression-free survival(Five years)
- visits to the hospital(One years)
研究者
Lei Li
Professor
Peking Union Medical College Hospital