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

January 2, 2019 updated by: Hoffmann-La Roche

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

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.

Study Overview

Status

Completed

Conditions

Ovarian Cancer, Peritoneal Neoplasms

Study Type

Observational

Enrollment (Actual)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Austria
- - Innsbruck, Austria, 6020
    - Tiroler Landeskrankenanstalten Ges.M.B.H.; Abt. Für Gynäkologie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Patients with newly diagnosed ovarian cancer (epithelial ovarian cancer, fallopian tube carcinoma or primary peritoneal carcinomas) with indication for carboplatin/paclitaxel chemotherapy in combination with Avastin

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
Cohort

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 15, 2012

Primary Completion (Actual)

October 11, 2018

Study Completion (Actual)

October 11, 2018

Study Registration Dates

First Submitted

February 8, 2013

First Submitted That Met QC Criteria