Ovarian Cancer
Conditions
Brief summary
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).
Interventions
DRUGBevacizumab
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.
DRUGCarboplatin
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.
DRUGPaclitaxel
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.
Sponsors
Hoffmann-La Roche
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
70 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants with Adverse Events | Per routine clinical practice during bevacizumab treatment (up to 15 months) |
| Time to First Incidence of Adverse Events of Special Interest | Per routine clinical practice during bevacizumab treatment (up to 15 months) |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival | 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 | 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) |
| Progression-Free Survival According to Response Evaluation Criteria in Solid Tumors (RECIST) | 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) |
| Total Number of Bevacizumab Doses | Every 3 weeks according to SmPC for up to 15 months |
| Percentage of Participants by Chemotherapy Used in Combination with Bevacizumab | Every 3 weeks per routine clinical practice for up to 18 weeks |
| Dosage of Bevacizumab in Milligrams per Kilogram (mg/kg) | Every 3 weeks according to SmPC for up to 15 months |
| Percentage of Participants with Complete or Partial Response According to RECIST | 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) |
Countries
Belgium
Outcome results
None listed