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

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 - JGOG3028

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000045931

Enrollment

300

Registered

2021-11-15

Start date

2022-01-17

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ovarian cancer, fallopian tube cancer, primary peritoneal cancer

Interventions

None listed

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Patients diagnosed with ovarian, fallopian tube, or primary peritoneal cancer 2. Patients diagnosed with FIGO(2014) stage III or IV 3 .Patients with complete or partial response by the initial platinum-based chemotherapy 4. Patients who started niraparib maintenance therapy after December 2020 5. Japanese female patients aged =>18 years (At the time of niraparib administration)

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Incidence of adverse events	—

Secondary

Measure	Time frame
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	—

Countries

Japan

Contacts

Public ContactHiroyuki Nomura

Tokai University Hospital Obstetrics and Gynecology

nomura.hiroyuki@tokai.ac.jp0463-93-1121

Outcome results