Intravenous Chemotherapy Versus Intraperitoneal Chemotherapy in Recurrent Ovarian Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- RFS
研究概览
简要总结
This study aims to compare intravenous chemotherapy versus intraperitoneal chemotherapy in patients with recurrent ovarian cancer.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women who had recurrent ovarian cancer and was treated with either intravenous or intraperitoneal platinum based chemotherapy
排除标准
- •women who did not complete the designated treatment course (exception to those who had to quit due to progressive disease or death of any cause)
研究组 & 干预措施
intravenous chemotherapy
triweekly chemotherapy with carboplatin AUC=5~6 + liposomal-doxorubicin 30~40mg/m2 or paclitaxel 175mg/m2 0r docetaxel 60~75mg/m2
干预措施: Chemotherapy (Drug)
intraperitoneal chemotherapy
Day 1 IV Paclitaxel 135 mg/m2 + IP Cisplatin 75-100 mg/m2 or IP carboplatin (AUC = 6) Day 8 IP Paclitaxel 60 mg/m2 Every 21 days * 6 cycles
OR
Day 1 IP Carboplatin AUC=5 or IP Cisplatin 50-75mg/m2 Day 2 IV Liposomal doxorubicin 15 mg/m2 + IP Liposomal doxorubicin 15 mg/m2 Every 28 days * 6 cycles
干预措施: Chemotherapy (Drug)
结局指标
主要结局
RFS
时间窗: the time interval from the date of surgery or the start of chemotherapy to clinically defined recurrence, disease progression, death from any cause or last follow-up
Recurrence free survival
OS
时间窗: the time interval from the date of surgery or the start of chemotherapy to the date of death from any cause or last follow-up
Overall Survival
次要结局
未报告次要终点
研究者
Sheng-Mou Hsiao
Professor
Far Eastern Memorial Hospital