BELOVA Data Collection: Safety and Efficacy of Frontline Bevacizumab Treatment in Participants With Ovarian Cancer 70 Years and Older

Sponsor
Hoffmann-La Roche
Study ID
NCT02393898
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
70 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bevacizumab — DRUG
    Bevacizumab will be prescribed by the local clinician according to the SmPC and standard of care for up to 15 months. No treatment will be provided by the Sponsor in this non-interventional study.
  • Carboplatin — DRUG
    Carboplatin will be prescribed by the local clinician according to local labeling and standard of care for up to 18 weeks. No treatment will be provided by the Sponsor in this non-interventional study.
  • Paclitaxel — DRUG
    Paclitaxel will be prescribed by the local clinician according to local labeling and standard of care for up to 18 weeks. No treatment will be provided by the Sponsor in this non-interventional study.

Study Details

The purpose of this study is to evaluate the safety and efficacy in the frontline treatment of ovarian cancer in participants 70 years of age and older in routine clinical practice in Belgium. Bevacizumab will be used in combination with carboplatin/paclitaxel followed by bevacizumab as maintenance in accordance with the Summary of Product Characteristics (SmPC).

Key Dates

First listed
Mar 20, 2015
Start date
Apr 23, 2015
Status verified
Jul 2019
Primary completion
Jun 14, 2019
Completion
Jun 14, 2019

Study Design

Enrollment
76 participants (actual)

Arms

  • Arm: Elderly Participants with Ovarian Cancer
    Elderly participants aged 70 years and older administered frontline treatment for International Federation for Gynecology and Obstetrics (FIGO) stage IV epithelial ovarian, fallopian tube, or primary peritoneal cancer with bevacizumab in combination with chemotherapy according to standard of care.

Primary Outcome Measure

Percentage of Participants with Adverse Events [ Time Frame: Per routine clinical practice during bevacizumab treatment (up to 15 months) ]

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