An Observational, Non-interventional Study of Niraparib Maintenance Treatment in Patients With Ovarian Cancer After Frontline Platinum-based Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 300
- 主要终点
- Starting dose of Niraparib
研究概览
简要总结
This is an open-label, single-arm, multi-center、non-interventional real-world study, which evaluate treatment pattern, safety and efficacy of Niraparib as first-line maintenance treatment for Chinese patient with newly diagnosed ovarian cancer , fallopian tube cancer, and primary peritoneal cancer in real world clinical practice.
详细描述
In this study, 300 patients will be enrolled. Eligible patients will be those with histologically confirmed epithelial ovarian cancer, carcinoma of fallopian tube or primary peritoneal carcinoma. Patients must have received one line of platinum-based chemotherapy, and be in clinically complete or partial response following the platinum-based chemotherapy prior to enrollment in the study. Patients will be treated with Niraparib according to the physician's judgement till disease progression, discontinuation for other reasons or death. The primary endpoint is treatment pattern of Niraparib as first-line maintenance treatment for ovarian cancer patients. The second endpoints include AE, PFS and quality of life.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •Women aged 18 years or older
- •Histologically confirmed epithelial ovarian cancer, carcinoma of fallopian tube or primary peritoneal carcinoma
- •Having received one line of platinum-based chemotherapy, and clinically CR or PR to this line of chemotherapy
- •Understand the protocol, and Written informed consent before any study-related procedure
排除标准
- •Participating in other clinical trials at the same time
- •Having sever or uncontrolled diseases that will influence the study, according to the judgement of investigators
- •Having other malignant tumors (other than breast cancer with BRCA mutation)
- •Pregnancy or breast feeding, or planning a pregnancy during the study
- •Unable to visit on time
- •Patients who are allergic to the study drug or drug components
结局指标
主要结局
Starting dose of Niraparib
时间窗: up to 3 years
Record the starting dose of Niraparib in real clinical practice
Percentage of patients who have taken dose adjustment and the reason of dose adjustment
时间窗: up to 3 years
Record the percentage of patients who have taken dose adjustment and the reason of dose adjustment
Percentage of patients who have taken dose discontinuation and the reason of dose discontinuation
时间窗: up to 3 years
Record the percentage of patients who have taken dose discontinuation and the reason of dose discontinuation
Concomitant treatments which patients take along with Niraparib
时间窗: up to 3 years
Record the concomitant treatments (drugs, or other tumor treatments) which patients take along with Niraparib
次要结局
- Incidence of all AEs(up to 3 years)
- Time to First Subsequent Therapy (TFST)(up to 3 years)
- Chemotherapy-Free Interval (CFI)(up to 3 years)
- Progression-free survival (PFS)(up to 3 years)
- Overall Survival (OS)(up to 3 years)
- Change From Baseline in EQ-5D-5L(up to 3 years)
研究者
Ling-Ying Wu
Professor
Chinese Academy of Medical Sciences