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OpenTrials
Completed

NCT Number: NCT04152941

Real-life Data of Olaparib in Relapsed Ovarian Cancers Patients

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.

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Key information

Conditions

Relapsed Ovarian Cancers Patients

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

ICO Paul Papin, Angers, France

Loading trial locations.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Olaparib

Drug

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

Primary outcomes

  1. progression free survival (PFS)

    Time frame: through study completion, an average of 1 year

    PFS (days) = date of progression - date of treatment start + 1

  2. overall Survival (OS)

    Time frame: through study completion, an average of 1 year

    OS (days) = date of death - date of treatment start + 1

  3. 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.

Sponsors and collaborators

Lead sponsor

ARCAGY/ GINECO GROUP

Other

Collaborators

  • AstraZeneca

Registry information

Official study title

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

Acronym: RETROLA

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Nov 6, 2019
Registry last updated
Sep 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.