Randomised Study With Docetaxel, Cisplatin and Cyclophosphamide vs Docetaxel and Carboplatin as First Line Chemotherapy With Advanced or Metastatic Ovarian Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Clinical examination including neurologic examination, vital signs (blood pressure, heart rate, temperature), weight, assessment of any residual toxicity due to previous therapy, assessment of performance status.
研究概览
简要总结
Primary objective:
To assess response rate. To record the clinical improvement in relation to stage and histopathological grading.
Secondary objective:
To determine progression free survival. To find out overall survival. To evaluate the safety of the study regimen.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 15 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Performance status Karnofsky index ≥ 60%.
- •Early stage as well as advanced/metastatic ovarian cancer proven by abdominal ultrasonography, chest x-ray, Computerized axial tomography scan.
- •Histologically: epithelial/germ cell
- •Haematology: absolute neutrophil count: ≥2X10^9/L; Platelet: ≥150X10^9/L; Haemoglobin: ≥ 10g/dL
- •Liver function: total bilirubin: ≤1X UNL (upper normal limit); Aspartate transaminase & Alanine aminotransferase: ≤2.5 x UNL; Alkaline phosphatase: ≤2.5 UNL
- •Renal function: Creatinine: ≤130 µmol/L; If creatinine > 130 µmol/L, the 24 hour creatinine clearance should be > 60 ml/min.
排除标准
- •Symptomatic peripheral neuropathy > grade 1 by National Cancer Institute - Common Toxicity Criteria scale
- •Uncontrolled diabetes mellitus and uncontrolled hypertension
- •Pregnant, or lactating patients(patients of childbearing potential must be using adequate contraception).
- •Active infection or other serious underlying medical condition not compatible with program entry eg. congestive heart failure, previous myocardial infarction within 6 months prior to treatment.
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
1
- Injection of Docetaxel
- 3-hour gap
- Injection of carboplatin
干预措施: Docetaxel (Drug)
1
- Injection of Docetaxel
- 3-hour gap
- Injection of carboplatin
干预措施: Carboplatin (Drug)
结局指标
主要结局
Clinical examination including neurologic examination, vital signs (blood pressure, heart rate, temperature), weight, assessment of any residual toxicity due to previous therapy, assessment of performance status.
时间窗: From the beginning to the end of study
Measurements of the disease (assessed clinically and/or by CA-125)
时间窗: At baseline and from administration of drug to end of treatment
Response rate
时间窗: From start to end of treatment
Adverse events
时间窗: From the beginning to the end of the study
次要结局
- Progression free survival(From administration of drug up to end of study)
- Overall survival(From administration of drug to end of study)
- Biology and Hematology laboratory determinations(From the beginning to the end of the study)