Characteristics related to Assessments of disease, patient and treatment associated with long-term survival in ovarian cancer patients (CAROLIN)-Intergroup study NOGGO/ A-AGO
- Conditions
- C56Malignant neoplasm of ovary
- Registration Number
- DRKS00017371
- Lead Sponsor
- ord-Ostdeutsche Gesellschaft für Gynäkologische Onkologie - NOGGO e.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Female
- Target Recruitment
- 300
• 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 histologically diagnosed relapsed 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
• Known hypersensitivity to the components of the product
• Pregnant or breast-feeding patients
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method • Evaluation of therapy management of Niraparib with focus on long term survival<br>• Identification of Niraparib specific factors associated with long-term survival (<5 vs >5 years)