BOVARI: A Non-Interventional Study of Avastin (Bevacizumab) as Front-Line Treatment in Patients With Ovarian Cancer

A Non-interventional Trial With Avastin as Front-line Treatment for Ovarian Cancer

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01788995

Enrollment

Registered

2013-02-11

Start date

2012-10-15

Completion date

2018-10-11

Last updated

2019-01-03

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

Conditions

Ovarian Cancer, Peritoneal Neoplasms

Brief summary

This non-interventional study will evaluate the routine use and the safety and efficacy of Avastin (bevacizumab) as first-line treatment in patients with advanced ovarian cancer (epithelial ovarian cancer, fallopian tube carcinoma, primary peritoneal carcinoma). Newly diagnosed patients who are initiated on carboplatin/paclitaxel chemotherapy in combination with Avastin will be followed for up to 15 months of treatment and 12 months of follow-up.

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 * Patients with newly diagnosed advanced epithelial ovarian cancer (EOC), fallopian tube carcinoma (FTC) or primary peritoneal carcinomas (PPC) with indication for first-line carboplatin/paclitaxel chemotherapy in combination with Avastin

Exclusion criteria

* Contraindications for Avastin according to the Summary of Product Characteristics

Design outcomes

Primary

Measure	Time frame
Clinical/demographic patient characteristics at initiation of treatment	approximately 4 years
Duration of treatment	approximately 4 years
Treatment discontinuations/modifications	approximately 4 years

Secondary

Measure	Time frame
Safety: Incidence of adverse events	approximately 4 years
Progression-free survival	approximately 4 years

Countries

Austria

Outcome results