Efficacy and Safety of PEGylated Recombinant Human Granulocyte Stimulating Factor in the Prevention of Neutropenia During Concurrent Chemoradiotherapy for Cervical Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Duration of grade 3-4 neutropenia
研究概览
简要总结
This randomized controlled prospective study aims to explore the efficacy and safety of using (PEGylated Recombinant Human Granulocyte Stimulating Factor) PEG-rhG-CSF to prevent neutropenia during concurrent chemoradiotherapy of paclitaxel and cisplatin (TP) regimen for cervical cancer. To find out the best time to use PEG-rhG CSF, and to explore investigate the effect of PEG-rhG-CSF on long-term bone marrow function in the process of concurrent chemoradiotherapy, and finally to explore the clinical feasibility of using PEG-rhG-CSF to prevent neutropenia during concurrent chemoradiotherapy of TP regimen for cervical cancer.
详细描述
Study design: In this prospective, single-center, randomized controlled study, patients with locally advanced cervical cancer are randomly divided into two groups. Patients in the experimental group will receive PEG-rhG-CSF 6mg prevention during concurrent chemoradiotherapy, whereas the control group do not use PEG-rhG-CSF for prevention. When the patient's ANC is less than 1✕109/L, 5μg/kg rhG-CSF will be given for treatment until the ANC returned to 2✕109/L.
Case selection: patients with IIb-IIIb cervical cancer, squamous cell carcinoma confirmed by histopathology, and three-week regimen of paclitaxel and carboplatin with Concurrent Radiotherapy.
Primary end point: incidence and duration of grade 3/4 neutropenia in patients. Secondary endpoints: 1) Incidence of febrile neutropenia (FN); 2) the rate of postponement of the course of radiotherapy, reduction in chemotherapy dose and postponement of the course of chemotherapy; 3) Changes of bone marrow function in patients 3 months and 6 months after radiotherapy.
Safety assessment: laboratory safety testing, including platelet count and hemoglobin. Evaluation of adverse events: infection, neutropenic fever, bone pain, etc.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •18-70 years old;
- •Patients with cervical cancer who have not undergone surgery for initial treatment, the international union of gynecology and obstetrics (FIGO) stage IIb-IIIb; Squamous cell carcinoma diagnosed by histopathology.
- •The expected survival time was more than 8 months; the Eastern Cooperative Oncology Group (ECOG) performance status score≤1;
- •Bone marrow hematopoietic function is normal before treatment (ANC≥1.8×109/L, PLT≥100×109/L, Hb≥90g/L, WBC≥4.0×109/L);
- •No obvious abnormality in the ECG examination, and no obvious cardiac dysfunction;
- •All patients must agree to take effective contraceptive measures during the study period and within 6 months after stopping treatment, and women of childbearing age must have a negative urine pregnancy test prior to treatment administration;
- •The subjects voluntarily participate in this clinical trial and sign an informed consent form.
排除标准
- •Those who refuse to accept PEG-rh-G-CSF;
- •Currently conducting clinical trials of other drugs;
- •Uncontrolled infection before treatment, body temperature ≥ 38℃;
- •Chronic diseases of the heart, kidney, liver or other important organs;
- •Patients with severe uncontrolled diabetes;
- •Pregnant or lactating female patients;
- •Persons with allergic diseases or allergic constitution, or allergic to this product or other biological products derived from genetically engineered E. coli;
- •Suspected or confirmed drug, substance or alcohol abuse;
- •Severe mental or neurological disorders that affect informed consent and/or adverse reaction presentation or observation;
- •HIV-positive people;
- •Patients requiring radiation therapy for the retroperitoneal or inguinal region.
研究组 & 干预措施
experimental group
patients used 6 mg PEG-rhG-CSF prophylactically after chemotherapy
干预措施: PEG-rhG-CSF (Drug)
control group
patients did not use PEG-rhG-CSF for prevention and were given 5 ug/kg rhG-CSF when ANC<1✕109/L
干预措施: rhG-CSF (Drug)
结局指标
主要结局
Duration of grade 3-4 neutropenia
时间窗: 2 months
Duration of grade 3-4 neutropenia
Incidence of Grade 3-4 neutropenia
时间窗: 2 months
Incidence of Grade 3-4 neutropenia
次要结局
- postponement of the course of chemotherapy(2 months)
- Incidence of febrile neutropenia (FN)(2 months)
- the rate of postponement of the course of radiotherapy(2 months)
- reduction in chemotherapy dose(2 months)
- Changes of bone marrow function in patients 3 months and 6 months after radiotherapy(6 months)
研究者
Dongling Zou
Associated Director
Chongqing University Cancer Hospital