Observational Retrospective Cohort Study in Patients With Relapsed Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer Treated With Olaparib Following Response to Platinium-based Chemotherapy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 130
- Locations
- 28
- Primary Endpoint
- progression free survival (PFS)
Study Overview
Brief Summary
This is a national, multi center, retrospective observational cohort study that will be carried out by reviewing the medical records of patients with relapsed epithelial ovarian, fallopian tube, or peritoneal cancer treated with olaparib following response to platinum-based chemotherapy.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients must be female ≥18 years of age
- •Patients with histologically confirmed ovarian cancer, primary peritoneal cancer and / or fallopian-tube cancer that were treated with olaparib in a real life-setting, between May 2014 to March 2017, whatever the line of therapy
- •Patients can be either alive or deceased at the time of medical record abstraction
- •Patients should not have any objection that anonymized data will be collected and subjected to automated processing.
Exclusion Criteria
- •Patient that were given olaparib within a clinical trial
Outcomes
Primary Outcomes
progression free survival (PFS)
Time Frame: through study completion, an average of 1 year
PFS (days) = date of progression - date of treatment start + 1
overall Survival (OS)
Time Frame: through study completion, an average of 1 year
OS (days) = date of death - date of treatment start + 1
incidence of events of clinical interest
Time Frame: through study completion, an average of 1 year
the following events: anemia, thrombopenia, nausea and vomiting, fatigue, myelodysplastic syndrome, upper respiratory infections, diarrhea, decreased appetite, dysgeusia and headache will be formally retrieved from the source documents.
Secondary Outcomes
No secondary outcomes reported