The Real World Efficacy and Safety of Niraparib in Korean Women With Primary and Recurrent Epithelial Ovarian Cancer

1. To evaluate the efficacy and safety of niraparib in Korean women with primary and recurrent epithelial ovarian cancer who underwent niraparib maintenance therapy 2. To evaluate the efficacy and safety of salvage niraparib therapy in Korean women with heavily pretreated epithelial ovarian cancer.

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Key information

Conditions

Epithelial Ovarian Cancer Adnexal Diseases Carcinoma Carcinoma, Ovarian Epithelial Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Ovarian Diseases Ovarian Neoplasms Urogenital Diseases Urogenital Neoplasms

Sex eligibility

Female

Study type

Observational

Primary location

Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center

Seoul, 138-736, South Korea

About this study

It has been three years since niraparib was introduced into Korea, and about 600 Korean patients with epithelial ovarian cancer have been treated with this drug. The efficacy and safety of niraparib in primary and recurrent epithelial ovarian cancer were well demonstrated in the NOVA trial and the PRIMA trial, and the efficacy and safety of niraparib in heavily pretreated epithelial ovarian cancer patients were confirmed in the -QUADRA trial. However, safety and efficacy data in Korean women are still scanty. The purpose of this study was to evaluate the safety and efficacy of niraparib in Korean women with primary and recurrent epithelial ovarian cancer.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients were diagnosed with all histologic type of epithelial ovarian cancer
Observation cohort (Cohort A): All patients who did not receive any kind of maintenance therapy for primary epithelial ovarian cancer from Dec 2019 to Dec 2022
Treatment cohort: Epithelial ovarian cancer patients who treated with niraparib as maintenance treatment in any line from Dec 2019 to Dec 2022

Cohort B: All patients who received or who are receiving niraparib maintenance therapy for primary epithelial ovarian cancer in 1st line setting
Cohort C: All patients who received or who are receiving niraparib maintenance therapy for recurrent epithelial ovarian cancer in 2nd or 3rd line setting
Cohort D: All patients who received or who are receiving salvage niraparib therapy for recurrent epithelial ovarian cancer in 4th line or more line setting

Exclusion criteria

Borderline ovarian tumor
Malignant ovarian germ cell tumor
Malignant sex-cord stroma tumor
Other malignancy within 5 years of diagnosis of epithelial ovarian cancer excluding carcinoma in situ of uterine cervix, endometrium, bladder, stomach, papillary thyroid cancer, and non-melanoma skin cancer

Treatment and study plan

Niraparib

Drug

Niraparib

Primary outcomes

Progression-free survival

Time frame: 3 years

Obtain a survival curve using the Kaplan-Meir method in all cohorts, and compare the survival rates between cohort A vs cohort B in total patients, BRCA WT and mutation patients using the log-rank test. Multivariate survival analysis will be performed using Cox's proportional hazard model.
Safety analysis

Time frame: 3 years

The fraction that adverse events occurred, the fraction that dose modification occurred, the fraction that dose delay occurred, and the fraction that treatment discontinuation occurred were calculated, respectively. The comparison of the fractions between groups will be done by the Chi-square test or the Fisher exact test. Comparison of means between groups will be done by Student t test or Mann-Whitney U test.
Overall survival analysis

Time frame: 3 years

Obtain a survival curve using the Kaplan-Meir method in all cohorts, and compare the survival rates between cohort A vs cohort B in total patients, BRCA WT and mutation patients using the log-rank test. Multivariate survival analysis is performed using Cox's proportional hazard model.

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Collaborators

Gangnam Severance Hospital
Inje University
Keimyung University Dongsan Medical Center
Kyungpook National University Chilgok Hospital
National Cancer Center, Korea
Pusan National University Hospital
Pusan National University Yangsan Hospital
Samsung Medical Center
Seoul National University Hospital
Seoul St. Mary's Hospital
Severance Hospital

Registry information

Acronym: REFIRM

Important dates

Study start: 2019
Primary completion: 2022
Study completion: 2022
First posted: Oct 17, 2023
Registry last updated: Feb 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed