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Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04986371
Study type Observational
Source Chinese Academy of Medical Sciences
Contact Lingying Wu
Phone 010-87788996
Email wulingying@csco.org.cn
Status Not yet recruiting
Phase
Start date August 10, 2021
Completion date February 28, 2025

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