NCT00490711已完成2 期
Phase II Study of Sequential Therapy With Paclitaxel Plus Carboplatin Followed by Gemzar Plus Carboplatin in the Treatment of Patients With Epithelial Ovarian Cancer FIGO Stages III-IV
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Overall response rate
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of paclitaxel and carboplatin followed by gemcitabine and carboplatin therapy for patients with epithelial ovarian cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically verified epithelial ovarian cancer
- •FIGO stage III-IV
- •Patients with measurable disease. RECIST criteria with GCIG modifications will be used for response and for progression assessment.
- •Lesions serving as measurable disease must have the longest diameter of greater than or equal to 20 mm as measured with conventional techniques or greater than or equal to 10 mm with spiral CT scan. Lesions measured by physical examination must have a longest diameter of greater than or equal to 20 mm.
排除标准
- •Ovarian tumors with low malignant potential (borderline tumors)
- •Non-epithelial ovarian or mixed epithelial. non epithelial tumors (e.g. mixed Mullerian tumors)
- •Time between definitive surgery and enrollment into the study is greater than 6 weeks
- •Patients who have received previous chemotherapy or radiotherapy
结局指标
主要结局
Overall response rate
次要结局
- Progression-free survival
- 2-year survival
- Toxicity
- Dose intensity
研究者
研究点 (1)
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