Real-life Data of Olaparib in Relapsed Ovarian Cancers Patients

Completed

• Conditions: Relapsed Ovarian Cancers Patients

• Registration Number: NCT04152941
• Lead Sponsor: ARCAGY/ GINECO GROUP

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-11
• Study First Submitted: 2019-10-22
• Study First Submitted QC: 2019-11-04
• Study First Posted: 2019-11-06
• Primary Completion: 2020-02-11
• Study Completion: 2020-02-11
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-05
• Last Update Posted: 2023-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 130

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
progression free survival (PFS)	through study completion, an average of 1 year	PFS (days) = date of progression - date of treatment start + 1
overall Survival (OS)	through study completion, an average of 1 year	OS (days) = date of death - date of treatment start + 1
incidence of events of clinical interest	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.

Trial Locations

Locations (28)

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

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