Relapsed Ovarian Cancers PatientsRETROLANCT04152941
Real-life Data of Olaparib in Relapsed Ovarian Cancers Patients
An observational study of Relapsed Ovarian Cancers Patients, run by ARCAGY/ GINECO GROUP at 28 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Relapsed Ovarian Cancers Patients
- What is being tested?
- Olaparib
- How many people
- 130 participants
- Where
- 28 sitesFrance
- Study dates
- 11 Oct 2018to 11 Feb 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Patient that were given olaparib within a clinical trial
Trial locations and contacts
28 sites in 1 country.
28 sites in 1 country
France28 sites
ICO Paul Papin
Angers, 49055
Institut Sainte-Catherine
Avignon, 84918
CHRU Jean Minjoz
Besançon, 25030
Clinique Tivoli
Bordeaux, 33000
Institut Bergonié
Bordeaux, 33076
Clinique Pasteur
Brest, 29200
Hôpital Morvan - Centre Hospitalier Universitaire
Brest, 29200
Centre Jean Perrin
Clermont-Ferrand, 63000
Centre Georges François Leclerc
Dijon, 21079
Groupe Hospitalier Mutualiste de Grenoble
Grenoble, 38028
Institut Hospitalier Franco-Britannique
Levallois-Perret, 92300
Centre Léon Bérard
Lyon, 69373
ICM Val d'Aurelle
Montpellier, 34298
ORACLE - Centre d'Oncologie de Gentilly
Nancy, 54100
Hôpital Privé du Confluent S.A.S.
Nantes, 44277
Centre Antoine Lacassagne
Nice, 6189
Centre Hospitalier Régional d'Orléans
Orléans, 45067
Hôpital Saint-Louis
Paris, 75010
Hôpital Cochin
Paris, 75014
Institut du Cancer Courlancy Reims
Reims, 51100
Centre Eugène Marquis
Rennes, 35042
Centre Hospitalier de Saint-Brieuc
Saint-Brieuc, 22015
ICO Centre René Gauducheau
Saint-Herblain, 44805
Clinique Mutualiste de l'Estuaire, Cité Sanitaire
Saint-Nazaire, 44600
Institut de Cancérologie Lucien Neuwirth
Saint-Priest-en-Jarez, 42271
Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091
ICL Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, 54511
Gustave Roussy
Villejuif, 94805
About this study
Official 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
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.
- Conditions
- Relapsed Ovarian Cancers Patients
- Being tested
- Olaparib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OlaparibDrug
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
What is being measured
The primary outcome is the main question the study is designed to answer.
progression free survival (PFS)
PFS (days) = date of progression - date of treatment start + 1
Measured: through study completion, an average of 1 year
overall Survival (OS)
OS (days) = date of death - date of treatment start + 1
Measured: 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.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2019
- Study start11 Oct 2018
- Primary completion11 Feb 2020
- Study completion11 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed Ovarian Cancers PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- ARCAGY/ GINECO GROUP
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
- Investigators
- Thibault de La Motte Rouge, Dr, Principal investigator, Centre Eugène Marquis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04152941
- Sponsor's protocol ID
- GINECO-OV-237
- Acronym
- RETROLA
- Status last verified
- Sep 2023
- First submitted
- 22 Oct 2019
- Last updated
- 6 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04152941
- Acronym / sponsor ID
- RETROLA / GINECO-OV-237
- Conditions
- Relapsed Ovarian Cancers Patients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- ARCAGY/ GINECO GROUPUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- 11 Oct 2018 (actual)
- Primary completion
- 11 Feb 2020 (actual)
- Study completion
- 11 Feb 2020 (actual)
- First posted
- 6 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Patient that were given olaparib within a clinical trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OlaparibPatients 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 | Drug | – |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2023.
- Individual participant dataSharing planned: No
Related trials for Relapsed Ovarian Cancers Patients
Active, not recruitingPhase 2
OSE2101 Alone or in Combination With Pembrolizumab vs BSC in Patient With Platinum-sensitive Recurrent OC
Platinum-sensitive Ovarian Cancer, Relapsed Ovarian Cancer
RecruitingPhase 1
A Study of PHST001 in Advanced Solid Tumors
Advanced Solid Tumors, Ovarian Cancer
RecruitingPhase 1/2
177Lu-BetaBart in Patients With Relapsed/Refractory, Locally Advanced Inoperable, or Metastatic Solid Tumors
Castration-Resistant Prostate Cancer (CRPC), Colorectal Cancer
RecruitingPhase 1/2
Evaluation of XYA02 in Patients With Advanced Solid Tumors
MUC1-expressing Advanced, Relapsed and/or Refractory Solid Tumors, Non-Small Cell Lung Cancer
RecruitingPhase 3
A Phase 3 Study of Manganese-primed Immunochemotherapy in Patients With Advanced Ovarian Cancer
Ovarian Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thibault de La Motte Rouge, Dr principal investigator
Centre Eugène Marquis
28 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Relapsed Ovarian Cancers Patients, run by ARCAGY/ GINECO GROUP at 28 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression free survival (PFS) (time frame: through study completion, an average of 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2023.