Niraparib Maintenance Treatment in Patients With Newly Diagnosed Advanced Platinum- Sensitive, OC. The First Poland RWE Study.
Trial Parameters
Brief Summary
The study is observational, not interventional. The study will include patients with advanced ovarian cancer who have been treated in Poland based on a previous early access program, and who are currently being treated under the B.50 drug program, funded by the National Health Fund. Only patients currently being treated in the B.50 program at 10 selected centers listed on this site may be included in the study. Of course, any patient in Poland eligible for maintenance treatment with niraparib can receive the drug, regardless of participation in this RWE study.The treatment involves administering niraparib as maintenance therapy for 3 years after the completion of chemotherapy, provided that the patient has responded to systemic treatment (NED, CR, PR).
Eligibility Criteria
Inclusion Criteria: 1. Patients must be female, ≥18 years of age, able to understand the study procedures, and agree to participate in the study by providing written informed consent. 2. Patients with a histologically confirmed diagnosis of nonmucinous high - grade epithelial ovarian cancer (serous, endometrial) that is stage III or IV according to the FIGO criteria. 3. All patients with Stage IV disease are eligible. This includes those with inoperable disease, those who undergo PDS (R0 or macroscopic disease), or those for whom NACT is planned. 4. Patients with Stage III are eligible if they meet the following criteria: 1. All FIGO III patients in spite of residual disease and cytoreductive surgery. 2. All patients with inoperable Stage III disease. 3. All Stage III patients after NACT chemotherapy. 5. FFPE tumor tissue sample must be available for molecular analysis. 6. Patients of childbearing potential must have a negative serum or urine pregnancy test (beta human chorionic gonado