A Randomized Phase III Study of Paclitaxel, Ifosfamide and Cisplatin Versus Vinblastine, Ifosfamide and Cisplatin as Second-Line Therapy for Patients With Relapsed/Resistant Germ Cell Tumors
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 79
- 主要终点
- Overall survival
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as ifosfamide, cisplatin, paclitaxel, and vinblastine, work in different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether ifosfamide and cisplatin are more effective when combined with paclitaxel or vinblastine in treating germ cell tumors.
PURPOSE: This randomized phase III trial is studying paclitaxel, ifosfamide, and cisplatin to see how well they work compared to vinblastine, ifosfamide, and cisplatin in treating men with progressive or recurrent metastatic germ cell tumors.
详细描述
OBJECTIVES:
Primary
- Compare the overall survival of men with progressive or recurrent metastatic germ cell tumors treated with paclitaxel, ifosfamide, and cisplatin vs vinblastine, ifosfamide, and cisplatin as second-line therapy.
Secondary
- Compare the progression-free survival of patients treated with these regimens.
- Compare the toxicity profiles of these regimens in these patients.
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 120 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Regimen B: VeIP
干预措施: ifosfamide (Drug)
Regimen B: VeIP
干预措施: vinblastine (Drug)
Regimen A: TIP
干预措施: cisplatin (Drug)
Regimen A: TIP
干预措施: ifosfamide (Drug)
Regimen A: TIP
干预措施: paclitaxel (Drug)
Regimen B: VeIP
干预措施: cisplatin (Drug)
结局指标
主要结局
Overall survival
时间窗: 2 months
次要结局
未报告次要终点