Clinical Trial: BOVARI: A Non-Interventional Study of Avastin (Bevacizumab) as Front-Line Treatment in Patients With Ovarian Cancer
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational
Official Title: A Non-interventional Trial With Avastin as Front-line Treatment for Ovarian Cancer
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.
Detailed Summary:
Sponsor: Hoffmann-La Roche
Current Primary Outcome:
- Clinical/demographic patient characteristics at initiation of treatment [ Time Frame: approximately 4 years ]
- Duration of treatment [ Time Frame: approximately 4 years ]
- Treatment discontinuations/modifications [ Time Frame: approximately 4 years ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Safety: Incidence of adverse events [ Time Frame: approximately 4 years ]
- Progression-free survival [ Time Frame: approximately 4 years ]
Original Secondary Outcome: Same as current
Information By: Hoffmann-La Roche
Dates:
Date Received: February 8, 2013
Date Started: October 2012
Date Completion: June 2017
Last Updated: November 1, 2016
Last Verified: November 2016