Real-life Data of Olaparib in Relapsed Ovarian Cancers Patients
RETROLA
Observational Retrospective Cohort Study in Patients With Relapsed Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer Treated With Olaparib Following Response to Platinium-based Chemotherapy
1 other identifier
observational
130
1 country
28
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2018
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 11, 2018
CompletedFirst Submitted
Initial submission to the registry
October 22, 2019
CompletedFirst Posted
Study publicly available on registry
November 6, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 11, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 11, 2020
CompletedSeptember 6, 2023
September 1, 2023
1.3 years
October 22, 2019
September 5, 2023
Conditions
Outcome Measures
Primary Outcomes (3)
progression free survival (PFS)
PFS (days) = date of progression - date of treatment start + 1
through study completion, an average of 1 year
overall Survival (OS)
OS (days) = date of death - date of treatment start + 1
through study completion, an average of 1 year
incidence of events of clinical interest
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
Interventions
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
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- Patient that were given olaparib within a clinical trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ARCAGY/ GINECO GROUPlead
- AstraZenecacollaborator
Study Sites (28)
ICO Paul Papin
Angers, 49055, France
Institut Sainte-Catherine
Avignon, 84918, France
CHRU Jean Minjoz
Besançon, 25030, France
Clinique Tivoli
Bordeaux, 33000, France
Institut Bergonié
Bordeaux, 33076, France
Clinique Pasteur
Brest, 29200, France
Hôpital Morvan - Centre Hospitalier Universitaire
Brest, 29200, France
Centre Jean Perrin
Clermont-Ferrand, 63000, France
Centre Georges François Leclerc
Dijon, 21079, France
Groupe Hospitalier Mutualiste de Grenoble
Grenoble, 38028, France
Institut Hospitalier Franco-Britannique
Levallois-Perret, 92300, France
Centre Léon Bérard
Lyon, 69373, France
ICM Val d'Aurelle
Montpellier, 34298, France
ORACLE - Centre d'Oncologie de Gentilly
Nancy, 54100, France
Hôpital Privé du Confluent S.A.S.
Nantes, 44277, France
Centre Antoine Lacassagne
Nice, 6189, France
Centre Hospitalier Régional d'Orléans
Orléans, 45067, France
Hôpital Saint-Louis
Paris, 75010, France
Hôpital Cochin
Paris, 75014, France
Institut du Cancer Courlancy Reims
Reims, 51100, France
Centre Eugène Marquis
Rennes, 35042, France
Centre Hospitalier de Saint-Brieuc
Saint-Brieuc, 22015, France
ICO Centre René Gauducheau
Saint-Herblain, 44805, France
Clinique Mutualiste de l'Estuaire, Cité Sanitaire
Saint-Nazaire, 44600, France
Institut de Cancérologie Lucien Neuwirth
Saint-Priest-en-Jarez, 42271, France
Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091, France
ICL Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, 54511, France
Gustave Roussy
Villejuif, 94805, France
MeSH Terms
Interventions
Study Officials
- PRINCIPAL INVESTIGATOR
Thibault de La Motte Rouge, Dr
Centre Eugène Marquis
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 22, 2019
First Posted
November 6, 2019
Study Start
October 11, 2018
Primary Completion
February 11, 2020
Study Completion
February 11, 2020
Last Updated
September 6, 2023
Record last verified: 2023-09
Data Sharing
- IPD Sharing
- Will not share