Spots Global Cancer Trial Database for Olaparib Real-world Utilization and Clinical Outcomes in France, Italy, and the UK
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Trial Identification
Brief Title: Olaparib Real-world Utilization and Clinical Outcomes in France, Italy, and the UK
Official Title: A Pan-European Non-interventional, Retrospective Observational Cohort Study of Patients With BRCA Mutated Advanced (FIGO Stage III-IV) Ovarian Cancer Treated With Olaparib Tablets in the First-line Maintenance Setting
Study ID: NCT04532645
Conditions
Interventions
Study Description
Brief Summary: This is a retrospective observational medical records review study of BRCA mutated advanced (FIGO stage III-IV) ovarian cancer patients who received first dose maintenance olaparib in 1L setting in France, Italy and the UK. Physicians who treated ovarian cancer patients with olaparib in 1L setting will be requested to recruit patients to have their clinical data abstracted from their clinical records in line with local laws
Detailed Description: Primary Objective(s) 1. To estimate progression-free survival (PFS) in patients with BRCA-mutated advanced ovarian cancer treated with olaparib tablets in real-world first line maintenance setting. 2. To describe olaparib treatment patterns (dosage; frequency of: dosage changes, dose interruptions, treatment cessation) in patients with BRCA-mutated advanced ovarian cancer treated in real-world first line maintenance setting. Secondary Objective(s) 1. To estimate overall survival (OS) in patients with BRCA-mutated advanced ovarian cancer treated with olaparib tablets in real-world first line maintenance setting. 2. To describe reasons for olaparib dosage changes, dose interruptions and treatment cessation in patients with BRCA-mutated advanced ovarian cancer treated in real-world first line maintenance setting 3. To describe surgical and chemotherapy outcomes (PR/CR) in patients with BRCA-mutated advanced ovarian cancer before initiation of real-world first line maintenance olaparib tablets 4. To describe response rate (RR) to olaparib tablets in patients with BRCA-mutated ovarian cancer with partial response to real-world first line chemotherapy. 5. To describe treatment patterns and clinical outcomes in patients with BRCA-mutated advanced ovarian cancer who progressed during olaparib real-world first line maintenance therapy (including frequency of treatment interruptions, dosage reductions and treatment discontinuations and reasons associated with patterns) 6. To estimate second progression-free survival (PFS2) in patients with BRCA-mutated ovarian cancer who progress while on olaparib real-world first line maintenance therapy. 7. To describe healthcare resource utilisation in patients with BRCA-mutated advanced ovarian cancer treated with olaparib in real-world first line setting
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Research Site, Saint Pierre, La Réunion (oversea France), France
Research Site, Avignon, , France
Research Site, Besancon, , France
Research Site, Bordeaux, , France
Research Site, Bordeaux, , France
Research Site, Bourg-en-Bresse, , France
Research Site, Brest, , France
Research Site, Calais, , France
Research Site, Chalon-sur-Saone, , France
Research Site, Chambray-les-Tours, , France
Research Site, Dijon, , France
Research Site, Epagny Metz-Tessy, , France
Research Site, Grenoble, , France
Research Site, Langon, , France
Research Site, Le Coudray, , France
Research Site, Lille, , France
Research Site, Lille, , France
Research Site, Limoges, , France
Research Site, Lyon, , France
Research Site, Marseille, , France
Research Site, Nancy, , France
Research Site, Paris, , France
Research Site, Paris, , France
Research Site, Paris, , France
Research Site, Pierre-Benite, , France
Research Site, Pontoise, , France
Research Site, Rennes, , France
Research Site, Roubaix, , France
Research Site, Saint-Cloud, , France
Research Site, Saint-Gregoire, , France
Research Site, Sainte Clotilde - La Reunion, , France
Research Site, Strasbourg, , France
Research Site, Suresnes, , France
Research Site, Tours, , France
Research Site, Valenciennes, , France
Research Site, Vandoeuvre-les-Nancy, , France
Research Site, Villejuif, , France
Research Site, Edinburgh, , United Kingdom
Research Site, Glasgow, , United Kingdom
Research Site, Leeds, , United Kingdom
Research Site, Liverpool, , United Kingdom
Research Site, London, , United Kingdom
Research Site, London, , United Kingdom
Research Site, London, , United Kingdom
Research Site, London, , United Kingdom
Research Site, Maidstone, , United Kingdom
Research Site, Manchester, , United Kingdom
Research Site, Newcastle, , United Kingdom
Research Site, Nottingham, , United Kingdom
Research Site, Portsmouth, , United Kingdom
Research Site, Surrey, , United Kingdom
Research Site, Swansea, , United Kingdom
Contact Details
Name: Charlie Gourley, MD, PhD
Affiliation: University of Edinburgh
Role: PRINCIPAL_INVESTIGATOR
Name: Domenica Lorusso, MD
Affiliation: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Role: PRINCIPAL_INVESTIGATOR
Name: Delphine Garbay, MD
Affiliation: Institut Bergonie, France
Role: PRINCIPAL_INVESTIGATOR
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