C56
Conditions
Interventions
Group 1: Data about treatment and medical history will be collected individually from each patient every 3 month for the duration of maintenance therapy and then every 6 month for a maximum of 7 years
Sponsors
Nord-Ostdeutsche Gesellschaft für Gynäkologische Onkologie - NOGGO e.V.
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • Female, age at least 18 years • Participant must be able to understand the study procedures and agree to participate in the study by providing written informed consent • For the last chemotherapy course prior to inclusion in the NIS the patient must have achieved a partial (PR) or complete (CR) tumor response • Patients eligible for Niraparib maintenance therapy according to SmPC and diagnosed with relapsed or primary advanced OC, fallopian tube cancer, or primary peritoneal cancer • Patients can be included after therapy decision of Niraparib treatment (decision to start Niraparib therapy must have been taken independently) and for up to 3 months after start of Niraparib therapy • Patient is able to take oral medications
Exclusion criteria
Exclusion criteria: • Known hypersensitivity to the components of the product • Pregnant or breast-feeding patients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Identification of disease, patient and treatment factors associated with long term survival. The quality of life is recorded by means of questionnaires, which are completed at each visit (during treatment with Niraparib every 3 months) to the end of treatment (4 weeks after the last dose of Niraparib). | — |
Secondary
| Measure | Time frame |
|---|---|
| • Evaluation of therapy management of Niraparib with focus on long term survival • Identification of Niraparib specific factors associated with long-term survival (5 years) | — |
Countries
Austria, Germany
Contacts
Public ContactYasemin Virk
Nord-Ostdeutsche Gesellschaft für Gynäkologische Onkologie - NOGGO e.V.
Outcome results
None listed