A Multicenter, Randomized Controlled, Open Clinical Study of the Efficacy and Safety of PEG-rhG-CSF in the Prevention of Neutropenia After Chemotherapy in Patients With Gynecological Malignancies
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Incidence of third/fourth level neutropenia
研究概览
简要总结
This study is a multi-center, forward-looking, open, randomized, controlled clinical trial. This study aims to analyze the effects of Mecapegfilgrastim Injection prevention versus non-prevention for neutropenia in ovarian cancer, cervical cancer, endometrial cancer patients after chemical therapy.
Patients are randomized into study group and control group. All patients receive PTX+platinum chemotherapy of 3 weeks. In study group, patients accept PEG-rhG-CSF 24-48 hours from the chemotherapy. While the control group patients are only observed closely. Patient receive three courses of treatment.
The primary end is the incidence of 3/4 level neutropenia in three courses of chemotherapy.
The secondary ends include: the incidences and duration of neutropenia in every course of chemotherapy, the incidences of FN in three courses and every course of chemotherapy, the incidences of infection in three courses and every course of chemotherapy, the delay time of the next cycle of chemotherapy due to FN or infection, the RDI of the second and third cycles of chemotherapy, adverse events related to G-CSF, quality of life, cost of medicine and admitting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 18-70
- •Weight ≥45 kg
- •≤2 lines chemotherapy or postoperative adjuvant chemotherapy patients with cervical cancer, ovarian cancer and endometrial cancer
- •Receive paclitaxel combined with platinum three weeks per cycle of chemotherapy
- •With an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1
- •Expected survival time of > 3 months
- •Main organ functions meet the following criteria:
- •Hb≥75g/L; WBC≥3.0×109/L; ANC≥1.5×109/L; PLT≥80×109/L;
- •APTT-ULN≤10s; PT-ULN≤3s; TT-ULN≤3s;
- •ALT≤2.5×ULN; AST≤2.5×ULN; TBIL≤2.5×ULN;
- •BUN≤1.5×ULN; Cr≤1.5×ULN; UA≤1.5×ULN；Creatinine clearance≥40mL/min;
- •without obvious cardiac dysfunction
- •Provided consent for participation
排除标准
- •With uncontrollable infections or receive systemic antibiotics within 72 hours prior to chemotherapy
- •Pregnant or lactating women
- •Received bone marrow or hematopoietic stem cell transplantation within the past 3 months
- •Concurrent chemoradiotherapy
- •Presence of hematological disorders: systemic lupus erythematosus, sjogren's syndrome, rheumatic autoimmune disease, mixed and hoof tissue disease, autoimmune hemolytic anemia, leukopenia , chronic granulocyte leukemia, bone marrow dysplasia syndrome, aplastic anemia, congenital and idiopathic neutropenia, myelodysplastic syndrome, cyclic neutropenia, primary and secondary thrombocytopenic purpura, etc
- •Presence of risk of thrombus or high risk of clotting
- •Presence of psychosis, neurological disease or brain metastases from tumors
- •Presence of uncontrollable complicated disease including symptomatic congestive heart failure, uncontrollable hypertension, unstable angina pectoris, active peptic ulcer, or hemorrhagic disease
- •Presence of uncontrollable infectious diseases, active viral hepatitis, tuberculosis, HIV
- •Allergic to recombinant human granulocyte stimulating factor or other biological products of E. coli origin
- •Received clinical trials within 1 month prior to enrollment
结局指标
主要结局
Incidence of third/fourth level neutropenia
时间窗: three months
Incidence of third/fourth level neutropenia during three cycles chemotherapy
次要结局
- delay time of chemotherapy(three months)
- The duration time of third/fourth level neutropenia(three months)
- Incidence of infection(three months)
- Adverse events(three months)
- Incidence of febrile neutropenia(three months)
- RDI of chemotherapy(three months)
研究者
Xiaohua Wu MD
director of gynecologic oncology
Fudan University