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

Hoffmann-La Roche76 enrolled

Overview

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).

Study Type

OBSERVATIONAL

Enrollment

Conditions

Ovarian Cancer

Interventions

BevacizumabDRUG

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.

CarboplatinDRUG

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.

PaclitaxelDRUG

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.

Eligibility

Sex: FEMALEMin age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Aged 70 years and older * No treatment with any other investigational agent within 28 days or 2 half-lives (whichever is longer) prior to enrollment Exclusion Criteria: * Contraindications, warnings, and precautions for bevacizumab

Locations (26)

Onze Lieve Vrouwziekenhuis Aalst

Aalst, Belgium

Outcomes

Primary Outcomes

Percentage of Participants with Adverse Events

Time frame: Per routine clinical practice during bevacizumab treatment (up to 15 months)

Time to First Incidence of Adverse Events of Special Interest

Time frame: Per routine clinical practice during bevacizumab treatment (up to 15 months)

Secondary Outcomes

Progression-Free Survival According to Response Evaluation Criteria in Solid Tumors (RECIST)

Time frame: Per routine clinical practice during bevacizumab treatment (up to 15 months) and at 6 and 12 months after end of bevacizumab (approximately 27 months overall)

Percentage of Participants with Complete or Partial Response According to RECIST

Time frame: Per routine clinical practice during bevacizumab treatment (up to 15 months) and at 6 and 12 months after end of bevacizumab (approximately 27 months overall)

Overall Survival

Time frame: Per routine clinical practice during bevacizumab treatment (up to 15 months) and at 6 and 12 months after end of bevacizumab (approximately 27 months overall)

Comprehensive Geriatric Assessment Subscale Scores

Time frame: Baseline, end of chemotherapy (up to 18 weeks), and after 10 and 15 months of bevacizumab treatment or at disease progression (up to 15 months overall)

Dosage of Bevacizumab in Milligrams per Kilogram (mg/kg)

Time frame: Every 3 weeks according to SmPC for up to 15 months

Total Number of Bevacizumab Doses

Time frame: Every 3 weeks according to SmPC for up to 15 months

Data from ClinicalTrials.gov

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