Clinical Trial: An Observational Study of Avastin (Bevacizumab) in Combination With Carboplatin/Paclitaxel in First Line in Patients With Advanced Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer (OTILIA)

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Non-interventional Surveillance Study (NIS) on First-line (FL) Bevacizumab (Avastin) in Combination With Carboplatin/Paclitaxel in Patients With Advanced Epithelial Ovarian, Fallopian Tube or Primary

Brief Summary: This observational study will evaluate the safety, efficacy, quality of life and predictive/selection factors for Avastin (bevacizumab) in combination with carboplatin/paclitaxel in first line in patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer in clinical practice. Data of eligible patients will be collected during up to 15 months of treatment and 12 months of follow-up. A second recruitment phase has been opened to focus on patients >/= 70 years.

Detailed Summary:
Sponsor: Hoffmann-La Roche

Current Primary Outcome:

  • Efficacy: Progression-free survival [ Time Frame: up to approximately 27 months ]
  • Safety: Incidence of adverse events [ Time Frame: approximately 5 years ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Quality of life: European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30/QLQ-OV28 questionnaires [ Time Frame: up to approximately 27 months ]
  • Selection criteria for first-line treatment with Avastin and carboplatin/paclitaxel: clinical/demographic patient characteristics [ Time Frame: approximately 5 years ]
  • Treatment discontinuations/modifications [ Time Frame: approximately 5 years ]
  • Treatment duration [ Time Frame: approximately 5 years ]


Original Secondary Outcome: Same as current

Information By: Hoffmann-La Roche

Dates:
Date Received: September 28, 2012
Date Started: February 2012
Date Completion:
Last Updated: November 1, 2016
Last Verified: November 2016