An observational study to investigate the safety and efficacy of niraparib maintenance therapy after primary chemotherapy for Japanese patients with advanced ovarian, fallopian tube, or primary peritoneal cancer
Not Applicable
- Conditions
- ovarian cancer, fallopian tube cancer, primary peritoneal cancer
- Registration Number
- JPRN-UMIN000045931
- Lead Sponsor
- Japanese Gynecologic Oncology Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- Female
- Target Recruitment
- 300
Inclusion Criteria
Not provided
Exclusion Criteria
1. Patients with active double cancer 2. Patients with prior treatment with PARP inhibitor 3. Patients judged by the investigator to be inappropriate for participation in this study
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of adverse events
- Secondary Outcome Measures
Name Time Method Progression-free survival (PFS) and PFS rate Response rate in patients with residual disease (ORR) Overall survival (OS) Relationship to subsequent therapy, platinum-free interval Incidence of secondary cancer