Niraparib as Maintenance Treatment in Platinum Responsive Ovarian Cancer Patients: a Real Life Study by MITO Group
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Progression free survival (PFS)
研究概览
简要总结
This is an observational phase IV study evaluating Niraparib as maintenance treatment in patients with platinum sensitive, platinum responsive, recurrent ovarian cancer in a real life setting.
详细描述
This is an observational phase IV study evaluating Niraparib as maintenance treatment in patients with platinum sensitive, platinum responsive, recurrent ovarian cancer in a real life setting. Will be enrolled all patients who have been part of the Italian Compassionate Use Program (CUP) prior to participating in this study. Once the CUP will be closed the trial will continue with th prospective collection of data of patients treated with Niraparib according to the label for 2 years.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •patients that received niraparib as monotherapy for the maintenance treatment of platinum-sensitive, relapsed, high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer after response (complete or partial) to platinum-based chemotherapy as part of the CUP, regardless of whether the patient is receiving niraparib at the time of enrolment;
- •patients with high grade serous ovarian cancer treated with Niraparib according to the label will be included;
- •patients able to understand the study procedures and that agree to participate in the study by providing written informed consent
排除标准
- •No exclusion criteria
结局指标
主要结局
Progression free survival (PFS)
时间窗: up to two years
To compare PFS of patients with advanced, platinum sensitive ovarian cancer treated with Niraparib as maintenance treatment
次要结局
- ORR(up to two years)
- TSST(up to two years)
- OS(up to two years)
- Incidence of treatment-emergent adverse events(up to two years)
- TFST(up to two years)