ICON7 - A Randomised, Two-Arm, Multi-Centre Gynaecologic Cancer InterGroup Trial of Adding Bevacizumab to Standard Chemotherapy (Carboplatin and Paclitaxel) in Patients With Epithelial Ovarian Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,520
- 试验地点
- 284
- 主要终点
- Progression-free survival
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. It is not yet known whether giving carboplatin and paclitaxel together with bevacizumab is more effective than carboplatin and paclitaxel alone in treating patients with ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cavity cancer.
PURPOSE: This randomized phase III trial is studying carboplatin, paclitaxel, and bevacizumab to see how well they work compared with carboplatin and paclitaxel alone in treating patients with newly diagnosed ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cavity cancer.
详细描述
OBJECTIVES:
Primary
- Compare the progression-free survival and overall survival of patients with newly diagnosed ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer treated with carboplatin and paclitaxel with vs without bevacizumab.
Secondary
- Compare the response rate in patients treated with these regimens.
- Compare the duration of tumor response in patients treated with these regimens.
- Compare the biological progression-free interval, as measured by increasing CA 125 levels, in patients treated with these regimens.
- Compare the safety (e.g., adverse events, laboratory results, and performance status) of these regimens in these patients.
- Compare the quality of life of patients treated with these regimens.
- Compare the cost-effectiveness of these regimens in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Progression-free survival
次要结局
- Duration of overall survival
- Objective response rate
- Duration of response
- Biological progression-free interval as measured by increasing CA 125 levels
- Safety as measured by NCI CTAE version 3.0
- Quality of life
- Health economics