Real-life Data of Olaparib in Relapsed Ovarian Cancers Patients (RETROLA)

September 5, 2023 updated by: ARCAGY/ GINECO GROUP

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

130

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France, 49055
        • ICO Paul Papin
      • Avignon, France, 84918
        • Institut Sainte-Catherine
      • Besancon, France, 25030
        • CHRU Jean Minjoz
      • Bordeaux, France, 33076
        • Institut Bergonie
      • Bordeaux, France, 33000
        • Clinique Tivoli
      • Brest, France, 29200
        • Clinique Pasteur
      • Brest, France, 29200
        • Hôpital Morvan - Centre Hospitalier Universitaire
      • Clermont-ferrand, France, 63000
        • Centre Jean Perrin
      • Dijon, France, 21079
        • Centre Georges François Leclerc
      • Grenoble, France, 38028
        • Groupe Hospitalier Mutualiste de Grenoble
      • Levallois Perret, France, 92300
        • Institut Hospitalier Franco-Britannique
      • Lyon, France, 69373
        • Centre Leon Berard
      • Montpellier, France, 34298
        • ICM Val d'Aurelle
      • Nancy, France, 54100
        • ORACLE - Centre d'Oncologie de Gentilly
      • Nantes, France, 44277
        • Hôpital Privé du Confluent S.A.S.
      • Nice, France, 6189
        • Centre Antoine Lacassagne
      • Orleans, France, 45067
        • Centre Hospitalier Regional D'Orleans
      • Paris, France, 75014
        • Hôpital COCHIN
      • Paris, France, 75010
        • Hôpital Saint-Louis
      • Reims, France, 51100
        • Institut du Cancer Courlancy Reims
      • Rennes, France, 35042
        • Centre Eugène Marquis
      • Saint-brieuc, France, 22015
        • Centre Hospitalier de Saint-Brieuc
      • Saint-herblain, France, 44805
        • ICO Centre René Gauducheau
      • Saint-nazaire, France, 44600
        • Clinique Mutualiste de l'Estuaire, Cité Sanitaire
      • Saint-priest-en-jarez, France, 42271
        • Institut de Cancérologie Lucien Neuwirth
      • Strasbourg, France, 67091
        • Hopitaux Universitaires de Strasbourg
      • Vandœuvre-lès-Nancy, France, 54511
        • ICL Institut de Cancérologie de Lorraine
      • Villejuif, France, 94805
        • Gustave Roussy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

The patient population observed in this study must fulfil all of the following 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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
progression free survival (PFS)
Time Frame: through study completion, an average of 1 year
PFS (days) = date of progression - date of treatment start + 1
through study completion, an average of 1 year
overall Survival (OS)
Time Frame: through study completion, an average of 1 year
OS (days) = date of death - date of treatment start + 1
through study completion, an average of 1 year
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.
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ARCAGY/ GINECO GROUP

Collaborators

AstraZeneca

Investigators

  • Principal Investigator: Thibault de La Motte Rouge, Dr, Centre Eugène Marquis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 11, 2018

Primary Completion (Actual)

February 11, 2020

Study Completion (Actual)

February 11, 2020

Study Registration Dates

First Submitted

October 22, 2019

First Submitted That Met QC Criteria

November 4, 2019

First Posted (Actual)

November 6, 2019

Study Record Updates

Last Update Posted (Actual)

September 6, 2023

Last Update Submitted That Met QC Criteria

September 5, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GINECO-OV-237

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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