C-PATROL - Non-interventional Study (NIS) to Collect Clinical and Patient Reported Outcome Data in an Olaparib Treated BRCAm+ PSR Ovarian Cancer Population
Completed
- Conditions
- Ovarian Cancer, Hereditary Ovarian Cancer Syndrome
- Registration Number
- NCT02503436
- Lead Sponsor
- AstraZeneca
- Brief Summary
The main objective of the proposed non-interventional study is to obtain real-world effectiveness, safety and treatment patterns data of patients with BRCAm+ (Breast Cancer Gene(s) mutation positive) platinum sensitive relapsed (PSR) ovarian cancer in German hospitals and outpatient practices treated with olaparib.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 276
Inclusion Criteria
- Signed written informed consent
- Women aged ≥ 18 years
- Patients with platinum sensitive relapsed high grade epithelial ovarian cancers (including primary peritoneal and/or fallopian tube cancer). (Platinum sensitive disease is defined as disease progression ≥6 months after completion of their last dose of platinum based chemotherapy. Patients must be currently in response to platinum-based chemotherapy. For the last chemotherapy course immediately prior to enrolment on the study, patients must be, in the opinion of the investigator, in response (partial or complete), following completion of this chemotherapy course.
- Documented BRCA mutations (germline and/or somatic mutation in BRCA1 (Breast Cancer gene 1) and/or BRCA2 (Breast Cancer gene 2) that is predicted to be deleterious or suspected deleterious (known or predicted to be detrimental/lead to loss of function))
- Patients should be in line with the specifications mentioned in the German LYNPARZA (olaparib) SmPC (Summary Product Characteristics) for hard capsules or tablets.
- Patients are able to read and understand German, English, Turkish or Arabic
Exclusion Criteria
- Known hypersensitivity to olaparib or any of the excipients of the drug
- Patients who have started olaparib monotherapy for more than 14 days before giving their informed consent
- Pregnancy or breast feeding
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess clinical effectiveness of olaparib maintenance monotherapy by assessment of progression free survival (PFS) in patients with BRCAm+ ovarian cancer. Methods and time intervals for tumor assessment depend on the investigator's decision. Date of first documented dose of olaparib to the date of progression (as judged by the investigator) or death (of any cause) whichever occurred before, assessed approximately up to 84 months
- Secondary Outcome Measures
Name Time Method Progression-free survival 2 (PFS2) Date of first administration of first subsequent therapy to date of progression as assessed by the investigator or death, assessed approximately up to 84 months Time to discontinuation of olaparib monotherapy (TDO) Date of first documented dose of olaparib montherapy to date of last documented dose of olaparib monotherapy or death whichever occurred before, assessed approximately up to 84 months Safety of Olaparib: collection of Adverse Events (AE) Date of first documented dose of Olaparib to last visit, assessed approximately up to 84 months Type and frequeny of adverse event (AE), intensity, causal relationship to olaparib, outcome, seriousness, management of adverse event
To collect and explore real-life data on patient outcomes in terms of Overall Survival (OS) Date of first documented dose of olaparib to death of any cause, assessed approximately up to 84 months Time to second subsequent therapy (TSST) Date of first documented dose of olaparib to date of first administration of second subsequent therapy or death if this occurs before commencement of second subsequent treatment, assessed approximately up to 84 months Time to first subsequent therapy (TFST) Date of first documented dose of olaparib to date of first administration of first subsequent therapy or death if this occurs before commencement of first subsequent treatment, assessed approximately up to 84 months Assessment of health-related quality of life (HRQoL) in patients participating in the study. Date of first visit to last visit. HRQoL are collected every 3 months up to 84 months Health related quality of life (HRQoL): Assessment of general cancer-associated and specific ovarian cancer associated parameters by use of standardized HRQoL questionnaires:
* Functional assessment of Cancer Therapy for Patients with Ovarian Cancer (FACT-O)
* Functional Assessment of Chronic Illness - Fatigue (FACIT-Fatigue)
* Functional Living Index - Emesis (FLIE)
Trial Locations
- Locations (1)
Research Site
🇩🇪Wuerzburg, Germany