Relapsed Ovarian Cancers Patients Clinical Trial
— RETROLAOfficial 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
| Verified date | September 2023 |
| Source | ARCAGY/ GINECO GROUP |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 130 |
| Est. completion date | February 11, 2020 |
| Est. primary completion date | February 11, 2020 |
| Accepts healthy volunteers | |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| France | ICO Paul Papin | Angers | |
| France | Institut Sainte-Catherine | Avignon | |
| France | CHRU Jean Minjoz | Besancon | |
| France | Clinique Tivoli | Bordeaux | |
| France | Institut Bergonié | Bordeaux | |
| France | Clinique Pasteur | Brest | |
| France | Hôpital Morvan - Centre Hospitalier Universitaire | Brest | |
| France | Centre Jean Perrin | Clermont-ferrand | |
| France | Centre Georges François Leclerc | Dijon | |
| France | Groupe Hospitalier Mutualiste de Grenoble | Grenoble | |
| France | Institut Hospitalier Franco-Britannique | Levallois Perret | |
| France | Centre Léon Bérard | Lyon | |
| France | ICM Val d'Aurelle | Montpellier | |
| France | ORACLE - Centre d'Oncologie de Gentilly | Nancy | |
| France | Hôpital Privé du Confluent S.A.S. | Nantes | |
| France | Centre Antoine Lacassagne | Nice | |
| France | Centre Hospitalier Régional d'Orléans | Orleans | |
| France | Hôpital Cochin | Paris | |
| France | Hôpital Saint-Louis | Paris | |
| France | Institut du Cancer Courlancy Reims | Reims | |
| France | Centre Eugène Marquis | Rennes | |
| France | Centre Hospitalier de Saint-Brieuc | Saint-brieuc | |
| France | ICO Centre René Gauducheau | Saint-herblain | |
| France | Clinique Mutualiste de l'Estuaire, Cité Sanitaire | Saint-nazaire | |
| France | Institut de Cancérologie Lucien Neuwirth | Saint-priest-en-jarez | |
| France | Hôpitaux Universitaires de Strasbourg | Strasbourg | |
| France | ICL Institut de Cancérologie de Lorraine | Vandœuvre-lès-Nancy | |
| France | Gustave Roussy | Villejuif |
| Lead Sponsor | Collaborator |
|---|---|
| ARCAGY/ GINECO GROUP | AstraZeneca |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | progression free survival (PFS) | PFS (days) = date of progression - date of treatment start + 1 | through study completion, an average of 1 year | |
| Primary | overall Survival (OS) | OS (days) = date of death - date of treatment start + 1 | through study completion, an average of 1 year | |
| Primary | 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 |