The Efficacy and Safety of Secondary Prophylaxis Versus ANC< 1000/mm3 Administration of PEG-rhG-CSF in Patients Receiving Cytotoxic Chemotherapy for Gynecologic Malignancies
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Incidence of grade 3/4 neutropenia
研究概览
简要总结
This study is a multicenter, open-label, randomized clinical trial. Patients with ovarian cancer receiving postoperative adjuvant chemotherapy were eligible to enroll in this study. Eligible patients were randomly allocated in a "1:1" to "Standard group" ( 6mg PEG-rhG-CSF was administrated subcutaneously in 24h after chemotherapy) and "Adjusted group" (6mg PEG-rhG-CSF was administrated subcutaneously when ANC < 1000/mm3 after chemotherapy). All patients need to receive at least 2 cycles of PEG-rhG-CSF administration. The primary outcome is the incidence of grade 3/4 neutropenia, and the duration of grade 3/4 neutropenia, the second outcomes are the incidence of FN, neutropenia-related hospitalization, incidence of reduction and delay of chemotherapy dose and safety of PEG-rhG-CSF.
详细描述
Patients with ovarian cancer receiving postoperative adjuvant chemotherapy were recruited and randomly allocated in a "1:1" to "Standard group" (6mg PEG-rhG-CSF was administrated subcutaneously in 24h after chemotherapy) and "Adjusted group" (6mg PEG-rhG-CSF was administrated subcutaneously when ANC < 1000/mm3 after chemotherapy). Eligible patients enrolled in this study need to receive 6 cycles of docetaxel or paclitaxel (including liposome paclitaxel) and carboplatin on day 1, every 3 weeks. All patients need to receive at least 2 cycles of PEG-rhG-CSF administration. The primary outcome is the incidence of grade 3/4 neutropenia, and the duration of grade 3/4 neutropenia, the second outcomes are the incidence of FN, neutropenia-related hospitalization, incidence of reduction and delay of chemotherapy dose and safety of PEG-rhG-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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Aged 18 years or older
- •Histopathology or cytology and immunomolecular biology diagnosed with ovarian cancer
- •Grade 3/4 neutropenia appeared in previous chemotherapy
- •accept at least 3 cycles of adjuvant chemotherapy
- •expected survival time ≥ 8 months; KPS>70
- •Normal bone marrow hematopoietic function: ANC≥1.5×109/L, PLT≥80×109/L, Hb≥75g/L, WBC ≥3.0×109/L
- •No obvious abnormalities in electrocardiogram examination, no obvious cardiac dysfunction
- •Liver function: ALT, TBIL, AST <= 2.5 ULN
- •Renal function: Cr, BUN <= 1.5 ULN
- •All patients must agree to take effective contraceptive measures during the study and within 6 months after discontinuing the treatment. Females of childbearing age must be negative in urinary pregnancy test before the treatment.
- •Before the start of the study, all patients have been fully understood the research and the must sign the informed consent.
排除标准
- •Uncontrolled infection, temperature≥38℃
- •patients with bone marrow dysplasia and other hematopoietic dysfunction , or accepted stem cell or bone marrow transplant in 3 months before recruitment
- •undergoing any other clinical trial in 4 weeks before recruitment
- •undergoing radiotherapy in 4 weeks before recruitment
- •Patients with other malignant tumors who have not been cured or have brain metastasis
- •Liver function: ALT, TBIL, AST > 2.5 ULN; If due to liver metastasis, ALT, TBIL, AST > 5 ULN; Renal function: Cr>1.5; Obvious abnormalities in electrocardiogram
- •Severe heart, kidney, liver and other important organs chronic diseases
- •severe and uncontrolled diabetes
- •Pregnancy or lactation in women or women of childbearing age refused to accept contraception
- •People with allergic diseases or allergies, or who are allergic to this or other genetically engineered Escherichia coli-derived biological products
- •Suspected or confirmed drug use, drug abuse, alcoholics
- •Severe mental or neurological disorders affecting informed consent and/or adverse effect presentation or observation
- •HIV positive
- •Syphilis infection
- •The investigator believes that the patient's condition is not suitable for this clinical study.
研究组 & 干预措施
Standard group
6mg PEG-rhG-CSF was administrated subcutaneously in 24h after chemotherapy.
干预措施: PEG-rhG-CSF (Drug)
Adjusted group
6mg PEG-rhG-CSF was administrated subcutaneously when ANC < 1000/mm3 after chemotherapy.
干预措施: PEG-rhG-CSF (Drug)
结局指标
主要结局
Incidence of grade 3/4 neutropenia
时间窗: At the end of cycle 2 (each cycle is 21 days)
Incidence of grade 3/4 neutropenia
The duration of grade 3/4 neutropenia
时间窗: At the end of cycle 2 (each cycle is 21 days)
The duration of grade 3/4 neutropenia
次要结局
未报告次要终点
研究者
Beihua Kong
Clinical Professor
Shandong University