Weekly Versus Every 3 Week Carboplatin and Paclitaxel in Patients With Ovarian Cancer: a Phase III Randomized Multicenter Study
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 800
- 试验地点
- 28
- 主要终点
- quality of life
研究概览
简要总结
The purpose of this study is to study efficacy and the effects on quality of life in women with ovarian cancer treated with a weekly schedule of chemotherapy with carboplatin and paclitaxel compared to those treated with standard every 3 weeks schedule of the same chemotherapy.
详细描述
The standard first-line treatment of ovarian cancer is combination chemotherapy with carboplatin and paclitaxel, given every 3 weeks. Researchers are looking at new ways of giving chemotherapy to make it more tolerable and more effective. One way is by giving the chemotherapy more often in smaller doses. This approach can be associated with fewer or less troubling side effects. Some chemotherapy drugs such as paclitaxel have been shown to also be more active when given once a week rather than once every 3 week schedule.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Cytologic or histologic diagnosis of ovarian carcinoma of the ovary, fallopian tube or primary peritoneal carcinoma, stage IC-IV
- •Indication for chemotherapy
- •Age > 18 years
- •Life expectancy of at least 3 months
排除标准
- •Previous or concomitant malignant malignancy (excluding adequately treated baso-or squamocellular carcinoma of the skin and carcinoma in situ of the cervix, and synchronous endometrioid carcinoma Stage Ib or less for the uterus, with ovarian tumor Stage II or higher)
- •Performance Status (ECOG) > or =
- •Previous chemotherapy
- •Heart disease (congestive heart failure, myocardial infarction within 6 months from study entry, atrioventricular block of any grade, severe arrhythmias)
- •Neutrophils < 2000 x mm3, platelets < 100000 x mm3
- •Inadequate renal function (creatinine > or = 1.25 x normal values) or liver function (ALT or AST > or = 1.25 x normal values)
- •Present or suspected hemorrhagic syndromes
- •Inability to comply with protocol and follow-up
- •Inability to access study site for clinical visits
- •Refusal of informed consent
研究组 & 干预措施
A
weekly chemotherapy
干预措施: carboplatin (Drug)
A
weekly chemotherapy
干预措施: paclitaxel (Drug)
B
every 3 weeks chemotherapy
干预措施: carboplatin (Drug)
B
every 3 weeks chemotherapy
干预措施: paclitaxel (Drug)
结局指标
主要结局
quality of life
时间窗: weekly for the first 9 weeks of therapy, then every 3 weeks until the completion of therapy
progression free survival
时间窗: every 6 months
次要结局
- overall survival(24 months)
- response rate(after 9 and 18 weeks of therapy)
- toxicity(weekly during therapy)
- describe the frequency and duration of symptoms in 12 months preceding ovarian cancer diagnosis(at study entry)
- describe time intervals of prediagnostic sentinel events (onset of persistent symptoms, first physician visit, diagnosis of ovarian cancer)(at study entry)
- describe patients' pathway to diagnosis of ovarian cancer according to modified Andersen's model of 'total patient delay'(at study entry)