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

Completed

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).

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Elderly Participants with Ovarian Cancer	Carboplatin	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.
Elderly Participants with Ovarian Cancer	Paclitaxel	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.
Elderly Participants with Ovarian Cancer	Bevacizumab	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 Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)
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)
Percentage of Participants by Chemotherapy Used in Combination with Bevacizumab	Every 3 weeks per routine clinical practice for up to 18 weeks
Total Number of Bevacizumab Doses	Every 3 weeks according to SmPC for up to 15 months
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)

Locations (26): UZ Antwerpen
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Edegem, Belgium
Sint Augustinus Wilrijk
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Wilrijk, Belgium
UZ Leuven Gasthuisberg
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Leuven, Belgium
CHU Sart-Tilman
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Liège, Belgium
AZ Nikolaas (Sint Niklaas)
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Sint Niklaas, Belgium
AZ Turnhout Sint Elisabeth
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Turnhout, Belgium
Onze Lieve Vrouwziekenhuis Aalst
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Aalst, Belgium
ZOL (Sint Jan)
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Genk, Belgium
AZ Maria Middelares
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Gent, Belgium
AZ Sint Lucas (Sint Lucas)
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Gent, Belgium
CHU St Pierre (St Pierre)
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Brussels, Belgium
Cliniques Uni Ires Saint-Luc; Gynaecology
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Bruxelles, Belgium
Chr de La Citadelle
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Liège, Belgium
Clinique Ste-Elisabeth
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Namur, Belgium
AZ Damiaan
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Oostende, Belgium
AZ Sint Lucas Brugge
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Assebroek, Belgium
AZ Sint Jan
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Brugge, Belgium
GHdC Site Notre Dame
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Charleroi, Belgium
CHR de Verviers - East Belgium
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Verviers, Belgium
Imeldaziekenhuis
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Bonheiden, Belgium
AZ KLINA
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Brasschaat, Belgium
UZ Gent
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Gent, Belgium
CH Jolimont - Lobbes (Jolimont)
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Haine-Saint-Paul, Belgium
Jessa Zkh (Campus Virga Jesse)
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Hasselt, Belgium
AZ Groeninge
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Kortrijk, Belgium
Clinique Saint-Joseph
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Liège, Belgium