Status:
COMPLETED
The Real World Efficacy and Safety of Niraparib in Korean Women With Primary and Recurrent Epithelial Ovarian Cancer
Lead Sponsor:
Asan Medical Center
Collaborating Sponsors:
Samsung Medical Center
Seoul National University Hospital
Conditions:
Epithelial Ovarian Cancer
Eligibility:
FEMALE
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 saf...
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 i...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 31 2022
Estimated Enrollment :
850 Patients enrolled
Trial Details
Trial ID
NCT06086665
Start Date
December 1 2019
End Date
October 31 2022
Last Update
October 17 2023
Active Locations (1)
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1
Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center
Seoul, South Korea, 138-736