Feasibility, Efficacy and Safety of Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) With Cisplatin and Doxorubicin in Women With Recurrent Ovarian Cancer: an Open-label, Single-arm Phase II Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- Clinical Benefit Rate
研究概览
简要总结
This trial aims to assess efficacy and safety of an intraperitoneal, aerosol, high-pressure chemotherapy in women with recurrent ovarian cancer
详细描述
This study aims to investigate the therapeutic efficacy of PIPAC using doxorubicin and cisplatin in women with recurrent ovarian cancer and disease progression with peritoneal carcinomatosis. The primary objective of this study is to determine the Clinical Benefit Rate (CBR) according to RECIST criteria after three cycles of PIPAC with cisplatin and doxorubicin.
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 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •at least 2 lines of previous chemotherapy
- •recurrent ovarian cancer
- •patient is mobile
- •informed consent
排除标准
- •necessity of parenteral nutrition
研究组 & 干预措施
intraperitoneal chemotherapy
Intraperitoneal chemotherapy with cisplatin at a dose of 7.5 mg/m2 body surface in a 150 ml NaCl 0.9% and doxorubicin at a dose of 1.5 mg/m2 body surface in a 50 ml NaCl 0.9% solution with a flow of 30 ml/min and a max upstream pressure of 200 psi.
干预措施: chemotherapy with doxorubicin and cisplatin (Drug)
结局指标
主要结局
Clinical Benefit Rate
时间窗: 6 months
The clinical benefit rate comprises complete remission, partial remission, and stable disease according to RECIST criteria.
次要结局
- safety(6 months)
研究者
Clemens Tempfer
Prof. Dr. med. Clemens Tempfer, MBA
Ruhr University of Bochum