The Real World Efficacy and Safety of Niraparib in Korean Women With Primary and Recurrent Epithelial Ovarian Cancer
NCT ID: NCT06086665
Last Updated: 2023-10-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
850 participants
OBSERVATIONAL
2019-12-01
2022-10-31
Brief Summary
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2. To evaluate the efficacy and safety of salvage niraparib therapy in Korean women with heavily pretreated epithelial ovarian cancer.
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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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
No interventions assigned to this group
Cohort B
All patients who received or who are receiving niraparib maintenance therapy for primary epithelial ovarian cancer in 1st line setting
Niraparib
Niraparib
Cohort C
All patients who received or who are receiving niraparib maintenance therapy for recurrent epithelial ovarian cancer in 2nd or 3rd line setting
Niraparib
Niraparib
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
Niraparib
Niraparib
Interventions
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Niraparib
Niraparib
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
FEMALE
No
Sponsors
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Samsung Medical Center
OTHER
Seoul National University Hospital
OTHER
Severance Hospital
OTHER
Gangnam Severance Hospital
OTHER
Keimyung University Dongsan Medical Center
OTHER
Kyungpook National University Chilgok Hospital
OTHER
Seoul St. Mary's Hospital
OTHER
National Cancer Center, Korea
OTHER_GOV
Pusan National University Yangsan Hospital
OTHER
Inje University
OTHER
Pusan National University Hospital
OTHER
Asan Medical Center
OTHER
Responsible Party
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Jeong-Yeol Park, MD, PhD
Professor
Locations
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Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center
Seoul, , South Korea
Countries
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Other Identifiers
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S2022-2461
Identifier Type: -
Identifier Source: org_study_id
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