NCT01481701已完成2 期
A Non Randomized Stratified Phase II Trial Evaluating Efficacy and Safety of Oxaliplatin in Combination With 5-Fluorouracil in Patients With Platinum-sensitive and Platinum-resistant Recurrent Ovarian Carcinoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Objective response rate
研究概览
简要总结
This is a Phase II study for recurrent ovarian carcinoma platinum-sensitive and resistant tumors Folfox regimen.
详细描述
Evaluation of the safety and the efficacy of a combination of oxaliplatin and 5FU (Folfox) in patients with ovarian carcinoma relapsing either after platinum-combined regimen.
The Folfox regimen is administered every 14 days. Evaluation of the toxicity is performed at each cycle and evaluation of the efficacy every 4 cycles of chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •ovarian carcinoma relapse
排除标准
- •neurotoxicity grade III renal clearance < 60 ml/min
研究组 & 干预措施
intravenous chemotherapy
Experimental
treatment of ovarian carcinoma in relapse
干预措施: oxaliplatin (Drug)
结局指标
主要结局
Objective response rate
时间窗: at 4 years
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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