C56
Conditions
Interventions
Group 1: Patients with rucaparib maintenance therapy. At baseline, demographics, family history, health history, treatment data and health data are queried, as well as questionnaires on quality of lif
Sponsors
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, histologically diagnosed high grade ovarian cancer, fallopian tube cancer, or primary peritoneal cancer, patient is eligible for rucaparib maintenance therapy according to SmPC, patient is able to take oral medications.
Exclusion criteria
Exclusion criteria: Known hypersensitivity to the components of the product, pregnant or breast-feeding patients, the patient is not allowed to participate in another interventional clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is to describe rucaparib adherence rate. The endpoint will be evaluated by a questionnaire. The questionnaire will be handed out to patients every 3 months during the treatment phase. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Evaluation of therapy management of Rucaparib with focus on compliance (including dose finding, adverse events, duration of treatment, QoL) • Side effect management • Estimated rate of PFS (defined as time to progression or death) rate after 6, 12 and 24 months • Time to next medical intervention (defined as tumor related treatment, e.g. chemotherapy, surgery, lumbar/pleural puncture) • Rate of treatment discontinuation due to treatment-emergent adverse events | — |
Countries
Germany
Contacts
Public ContactAnna-Maria Mira-Conti
Charité Universitätsklinikum BerlinCampus Virchow KlinikumKlinik für Gynäkologie
Outcome results
None listed