Clinical trial NCT06086665: The Real World Efficacy and Safety of Niraparib in Korean Women With Primary and Recurrent Epithelial Ovarian Cancer
Official title: The Real World Efficacy and Safety of Niraparib in Korean Women With Primary and Recurrent Epithelial Ovarian Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epithelial Ovarian Cancer
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
Collaborators: name: Samsung Medical Center
name: Seoul National University Hospital
name: Severance Hospital
name: Gangnam Severance Hospital
name: Keimyung University Dongsan Medical Center
name: Kyungpook National University Chilgok Hospital
name: Seoul St. Mary's Hospital
name: National Cancer Center, Korea
name: Pusan National University Yangsan Hospital
name: Inje University
name: Pusan National University Hospital
First posted: 2023-10-17
Enrollment: 850
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Considering the nature of retrospective study, sample size cannot be calculated based on reference. We have a plan to collect the patient data as much as possible from multi-centers.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Progression-free survival
timeFrame: 3 years
measure: Safety analysis
timeFrame: 3 years
measure: Overall survival analysis
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center
Study officials:
References: