An Observational Study of Avastin (Bevacizumab) in Combination With Chemotherapy as First-Line Treatment in Patients With Advanced Ovarian Cancer (OSCAR 1)
- Conditions
- Ovarian Cancer
- Registration Number
- NCT01863693
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This multicenter, prospective, observational study will evaluate the safety and efficacy of Avastin (bevacizumab) in combination with chemotherapy as first-line treatment in patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer in routine clinical practice. Eligible patients will be followed for approximately 15 months.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 300
- Adult patients, >/= 18 years of age
- Advanced (FIGO stages IIIB, IIIC and IV) epithelial ovarian, fallopian tube or primary peritoneal cancer not previously treated with chemotherapy
- Initiating Avastin in combination with chemotherapy
- Contraindications, warnings and precautions for use as specified in the Avastin Summary of Product Characteristics
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety: Incidence of adverse events approximately 6 years Progression-free survival, defined as time from first administration of first-line therapy to documented disease progression approximately 6 years
- Secondary Outcome Measures
Name Time Method Objective response rate, defined as percentage of patients with complete or partial response according to local assessments approximately 6 years Quality of life: EQ-5D/EORTC questionnaires approximately 6 years Composition of first-line chemotherapy regimens: drugs/dosage/duration approximately 6 years Overall survival, defined as time from first administration of first-line therapy to documented death approximately 6 years Dosage/schedule/duration of Avastin therapy approximately 6 years
Trial Locations
- Locations (30)
Queen Alexandra Hospital; Portsmouth Haematology & Oncology Centre, Level B
🇬🇧Portsmouth, United Kingdom
Royal United Hospital; Oncology Department
🇬🇧Bath, United Kingdom
Eastborne District General Hospital
🇬🇧Eastbourne, United Kingdom
Christie Hospital Nhs Trust; Medical Oncology
🇬🇧Manchester, United Kingdom
St James University Hospital
🇬🇧Leeds, United Kingdom
The Royal Marsden Hospital
🇬🇧Sutton, United Kingdom
Southampton General Hospital
🇬🇧Southampton, United Kingdom
Weston Park Hospital; Cancer Clinical Trials Centre
🇬🇧Sheffield, United Kingdom
City General Hospital
🇬🇧Stoke-on-Trent, United Kingdom
Singleton Hospital; Oncology
🇬🇧Swansea, United Kingdom
Bradford Royal Infirmary; Oncology Department
🇬🇧Bradford, United Kingdom
Bristol Haematology and Oncology Centre
🇬🇧Bristol, United Kingdom
Queen's Hospital; Oncology Department
🇬🇧Burton on Trent, United Kingdom
Essex County Hospital
🇬🇧Colchester, United Kingdom
Wonford Hospital; Oncology Department
🇬🇧Exeter, United Kingdom
Royal Surrey County Hospital
🇬🇧Guildford, United Kingdom
Royal Marsden Hospital - London
🇬🇧London, United Kingdom
Airedale General Hospital; Research Office Ward 12
🇬🇧Keighley, United Kingdom
Maidstone Hospital; Kent Oncology Centre
🇬🇧Maidstone, United Kingdom
Mount Vernon Hospital
🇬🇧Middlesex, United Kingdom
St Mary's Hospital
🇬🇧Newport, United Kingdom
The James Cook University Hospital
🇬🇧Middlesborough, United Kingdom
City Campus; Academic Unit of Oncology
🇬🇧Nottingham, United Kingdom
Torbay Hospital; Oncology Department
🇬🇧Torquay, United Kingdom
Royal Cornwall Hospital
🇬🇧Truro, United Kingdom
The Clatterbridge Cancer Centre NHS Foundation Trust
🇬🇧Wirral, United Kingdom
New Cross Hospital; Deansley Centre
🇬🇧Wolverhampton, United Kingdom
Ipswich Hospital
🇬🇧Ipswich, United Kingdom
City Hospital
🇬🇧Birmingham, United Kingdom
The York Hospital
🇬🇧York, United Kingdom