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An Observational Study of Avastin (Bevacizumab) in Combination With Chemotherapy as First-Line Treatment in Patients With Advanced Ovarian Cancer (OSCAR 1)

Completed
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
Inclusion Criteria
  • 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
Exclusion Criteria
  • 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
NameTimeMethod
Safety: Incidence of adverse eventsapproximately 6 years
Progression-free survival, defined as time from first administration of first-line therapy to documented disease progressionapproximately 6 years
Secondary Outcome Measures
NameTimeMethod
Objective response rate, defined as percentage of patients with complete or partial response according to local assessmentsapproximately 6 years
Quality of life: EQ-5D/EORTC questionnairesapproximately 6 years
Composition of first-line chemotherapy regimens: drugs/dosage/durationapproximately 6 years
Overall survival, defined as time from first administration of first-line therapy to documented deathapproximately 6 years
Dosage/schedule/duration of Avastin therapyapproximately 6 years

Trial Locations

Locations (30)

Royal United Hospital; Oncology Department

🇬🇧

Bath, United Kingdom

City Hospital

🇬🇧

Birmingham, 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

Eastborne District General Hospital

🇬🇧

Eastbourne, United Kingdom

Wonford Hospital; Oncology Department

🇬🇧

Exeter, United Kingdom

Royal Surrey County Hospital

🇬🇧

Guildford, United Kingdom

Ipswich Hospital

🇬🇧

Ipswich, United Kingdom

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Royal United Hospital; Oncology Department
🇬🇧Bath, United Kingdom

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