Long-acting Versus Short-acting Granulocyte Colony Stimulating Factor for the Prevention of Febrile Neutropenia in Epithelial Ovarian Cancer Patients: A Multicenter Phase 3 Randomized Controlled Study
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 200
- 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 versus short-acting granulocyte colony stimulating factor (G-CSF) on the prevention febrile neutropenia (FN) in epithelial ovarian cancer patients.
Patients receive platinum-based chemotherapy of 3 to 4 weeks. 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 or prophylactic treatment of short-acting G-CSF according to National Comprehensive Cancer Network guidelines.
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, quality of life, and survival outcomes (progression-free survival and overall survival).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •With definitive pathological results of epithelial ovarian cancer
- •With an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2
- •Aged 18 or older
- •Receiving 3-4 weeks per cycle of platinum-based chemotherapy with or without debulking surgery
- •Regularly followed up in the study centers
- •Provided consent for participation.
排除标准
- •Failure to meet all the inclusion criteria
- •Non-compliance with the study protocols
- •With a history of chemotherapy or pelvic radiotherapy for malignancies
- •Presence of immunosuppressive diseases such as organ transplantation or acquired immune deficiency syndrome
- •Treated with weekly chemotherapy regimens
- •Presence of hematological disorders
研究组 & 干预措施
Study group
Patients in study group accept prophylactic treatment of long-acting granulocyte colony stimulating factor
干预措施: Long-acting granulocyte colony stimulating factor (Drug)
Control group
Patients in control group accept regular or prophylactic treatment of short-acting granulocyte colony stimulating factor according to current guidelines
干预措施: Short-acting granulocyte colony stimulating factor (Drug)
结局指标
主要结局
Incidence of febrile neutropenia
时间窗: One year
Incidence of febrile neutropenia during each course of chemotherapy
次要结局
- Adverse events(One years)
- Progression-free survival(Two years)
- Overall survival(Two years)
- Incidence of myelosuppression(One year)
- Doses of granulocyte colony stimulating factor(One year)
- Numbers of visits to the hospital(One year)
研究者
Lei Li
Professor
Peking Union Medical College Hospital