Registry of Rucaparib in Clinical Practice – An evaluation of clinical experience in Germany
- Conditions
- C56Malignant neoplasm of ovary
- Registration Number
- DRKS00022863
- Lead Sponsor
- OGGO e.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting stopped after recruiting started
- Sex
- Female
- Target Recruitment
- 15
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
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.
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method • Evaluation of therapy management of Rucaparib with focus on compliance (including dose finding, adverse events, duration of treatment, QoL)<br><br>• Side effect management <br><br>• Estimated rate of PFS (defined as time to progression or death) rate after 6, 12 and 24 months <br><br>• Time to next medical intervention (defined as tumor related treatment, e.g. chemotherapy, surgery, lumbar/pleural puncture)<br><br>• Rate of treatment discontinuation due to treatment-emergent adverse events