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

AN OBSERVATIONAL STUDY OF AVASTIN® (BEVACIZUMAB) AS FIRST LINE THERAPY IN PATIENTS WITH ADVANCED OVARIAN CANCER

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01863693

Enrollment

300

Registered

2013-05-29

Start date

2013-05-10

Completion date

2018-06-15

Last updated

2018-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian Cancer

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Progression-free survival, defined as time from first administration of first-line therapy to documented disease progression	approximately 6 years
Safety: Incidence of adverse events	approximately 6 years

Secondary

Measure	Time frame
Composition of first-line chemotherapy regimens: drugs/dosage/duration	approximately 6 years
Quality of life: EQ-5D/EORTC questionnaires	approximately 6 years
Overall survival, defined as time from first administration of first-line therapy to documented death	approximately 6 years
Objective response rate, defined as percentage of patients with complete or partial response according to local assessments	approximately 6 years
Dosage/schedule/duration of Avastin therapy	approximately 6 years

Countries

United Kingdom

Outcome results