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

Ovarian Cancer Clinical Trial

Official title:

BELOVA: A Non-Interventional Study to Collect Data on the Safety and Efficacy of Frontline Bevacizumab Treatment in Ovarian Cancer Patients 70 Years and Older

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02393898
• Other study ID #: ML29515
• Status: Completed
• Start date: April 23, 2015
• Est. completion date: June 14, 2019

Study information

• Verified date: July 2019
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: June 14, 2019
• Est. primary completion date: June 14, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 70 Years and older

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:

• Contraindications, warnings, and precautions for bevacizumab

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Drug:
• Bevacizumab
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
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
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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants with Adverse Events		Per routine clinical practice during bevacizumab treatment (up to 15 months)
Primary	Time to First Incidence of Adverse Events of Special Interest		Per routine clinical practice during bevacizumab treatment (up to 15 months)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Dosage of Bevacizumab in Milligrams per Kilogram (mg/kg)		Every 3 weeks according to SmPC for up to 15 months
Secondary	Total Number of Bevacizumab Doses		Every 3 weeks according to SmPC for up to 15 months
Secondary	Percentage of Participants by Chemotherapy Used in Combination with Bevacizumab		Every 3 weeks per routine clinical practice for up to 18 weeks