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Real-life Data of Olaparib in Relapsed Ovarian Cancers Patients

Observational Retrospective Cohort Study in Patients With Relapsed Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer Treated With Olaparib Following Response to Platinium-based Chemotherapy

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04152941
Acronym
RETROLA
Enrollment
130
Registered
2019-11-06
Start date
2018-10-11
Completion date
2020-02-11
Last updated
2023-09-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Relapsed Ovarian Cancers Patients

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.

Interventions

DRUGOlaparib

Patients with histologically confirmed ovarian cancer, primary peritoneal cancer and / or fallopian-tube cancer treated with olaparib in a real life-setting, between May 2014 to March 2017, whatever the line of therapy

Sponsors

AstraZeneca
CollaboratorINDUSTRY
ARCAGY/ GINECO GROUP
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum

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

Design outcomes

Primary

MeasureTime frameDescription
progression free survival (PFS)through study completion, an average of 1 yearPFS (days) = date of progression - date of treatment start + 1
overall Survival (OS)through study completion, an average of 1 yearOS (days) = date of death - date of treatment start + 1
incidence of events of clinical interestthrough study completion, an average of 1 yearthe 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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026