OSCA - Olaparib Standard of CAre Study

Completed

• Conditions: Platinum-sensitive Recurrent Serous Ovarian Cancer
• Interventions: Other: Data Collection

• Registration Number: NCT02262273
• Lead Sponsor: AstraZeneca

Brief Summary

This study will be carried out as a retrospective, non-interventional observational review of medical records for patients in multiple countries with platinum-sensitive recurrent serous ovarian cancer. The objectives are to describe in a real-world population, treatment patterns, BRCA mutation testing and results, overall survival, health care utilization and also to estimate rates of selected treatment- and/or disease-related side effects

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2014-10-06
• Study First Submitted QC: 2014-10-09
• Study First Posted: 2014-10-13
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-28
• Last Update Posted: 2017-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 2123

Inclusion Criteria

1. First determined to have platinum-sensitive recurrent serous ovarian cancer between January 1, 2009, and December 31, 2013 (study entry period), as defined by no evidence of disease progression for at least 6 months after completion of a first-line platinum-based chemotherapy regimen; the first date of platinum-sensitive recurrence between January 1, 2009 and December 31, 2013 will define the study index date.
2. At least 18 years of age on the index date.
3. Fully documented medical history related to the patient's ovarian cancer treatment beginning with initial diagnosis of serous ovarian cancer.
4. Patients can be either alive or deceased at the time of medical record abstraction.

Exclusion Criteria

1. Ever taken an investigational product as part of an interventional clinical trial for ovarian cancer.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Serous ovarian cancer:	Data Collection	Women with platinum-sensitive recurrent serous ovarian cancer

Primary Outcome Measures

Name	Time	Method
Best response to therapy and date of response for each subsequent therapy line post-index	Data will be collected retrospectively from medical records	Response categories: complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD) Criteria on which physicians determined therapy response also will be captured (e.g., symptoms, radiological and/or other imaging findings, CA-125 levels, physical exam, or other criteria).

Secondary Outcome Measures

Name	Time	Method
Progression-free survival, by therapy line	Data will be collected retrospectively from medical records	Defined as time from initiation of the therapy line (including the required first-line platinum-based chemotherapy) until the earliest of progression, death, or end of follow-up (for censored observations) Criteria on which physicians determined progression also will be captured (e.g., symptoms, radiological and/or other imaging findings, CA-125 levels, physical exam, or other criteria)
Overall survival, calculated from various time points	Data will be collected retrospectively from medical records	From first diagnosis of ovarian cancer until death or end of follow-up, whichever is earliest From initiation of the required first-line platinum-based chemotherapy regimen until death or end of follow-up, whichever is earliest From the index date (first determination of platinum-sensitive recurrence) until death or end of follow-up, whichever is earliest From initiation of each subsequent, post-index therapy line until death or end of follow-up, whichever is earliest

Trial Locations

Locations (1)

Research Site; 🇬🇧 Wolverhampton, United Kingdom