Clinical trial NCT02393898: BELOVA Data Collection: Safety and Efficacy of Frontline Bevacizumab Treatment in Participants With Ovarian Cancer 70 Years and Older
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ovarian Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2015-03-20
Enrollment: 76
Sex: FEMALE
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Real-world patients (70 years of age and older) with epithelial ovarian, fallopian tube, or primary peritoneal cancer who are receiving frontline treatment with bevacizumab and chemotherapy according to standard of care.

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).


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants with Adverse Events
timeFrame: Per routine clinical practice during bevacizumab treatment (up to 15 months)
measure: Time to First Incidence of Adverse Events of Special Interest
timeFrame: Per routine clinical practice during bevacizumab treatment (up to 15 months)
Secondary outcomes:
measure: Progression-Free Survival According to Response Evaluation Criteria in Solid Tumors (RECIST)
timeFrame: 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)
measure: Percentage of Participants with Complete or Partial Response According to RECIST
timeFrame: 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)
measure: Overall Survival
timeFrame: 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)
measure: Comprehensive Geriatric Assessment Subscale Scores
timeFrame: 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)
measure: Dosage of Bevacizumab in Milligrams per Kilogram (mg/kg)
timeFrame: Every 3 weeks according to SmPC for up to 15 months
measure: Total Number of Bevacizumab Doses
timeFrame: Every 3 weeks according to SmPC for up to 15 months
measure: Percentage of Participants by Chemotherapy Used in Combination with Bevacizumab
timeFrame: Every 3 weeks per routine clinical practice for up to 18 weeks
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: Onze Lieve Vrouwziekenhuis Aalst
city: Assebroek
country: Belgium
facility: AZ Sint Lucas Brugge
city: Bonheiden
country: Belgium
facility: Imeldaziekenhuis
city: Brasschaat
country: Belgium
facility: AZ KLINA
city: Brugge
country: Belgium
facility: AZ Sint Jan
city: Brussels
country: Belgium
facility: CHU St Pierre (St Pierre)
city: Bruxelles
country: Belgium
facility: Cliniques Uni Ires Saint-Luc; Gynaecology
city: Charleroi
country: Belgium
facility: GHdC Site Notre Dame
city: Edegem
country: Belgium
facility: UZ Antwerpen
city: Genk
country: Belgium
facility: ZOL (Sint Jan)
city: Gent
country: Belgium
facility: AZ Maria Middelares
city: Gent
country: Belgium
facility: AZ Sint Lucas (Sint Lucas)
city: Gent
country: Belgium
facility: UZ Gent
city: Haine-Saint-Paul
country: Belgium
facility: CH Jolimont - Lobbes (Jolimont)
city: Hasselt
country: Belgium
facility: Jessa Zkh (Campus Virga Jesse)
city: Kortrijk
country: Belgium
facility: AZ Groeninge
city: Leuven
country: Belgium
facility: UZ Leuven Gasthuisberg
city: Liège
country: Belgium
facility: Chr de La Citadelle
city: Liège
country: Belgium
facility: CHU Sart-Tilman
city: Liège
country: Belgium
facility: Clinique Saint-Joseph
city: Namur
country: Belgium
facility: Clinique Ste-Elisabeth
city: Oostende
country: Belgium
facility: AZ Damiaan
city: Sint Niklaas
country: Belgium
facility: AZ Nikolaas (Sint Niklaas)
city: Turnhout
country: Belgium
facility: AZ Turnhout Sint Elisabeth
city: Verviers
country: Belgium
facility: CHR de Verviers - East Belgium
city: Wilrijk
country: Belgium
facility: Sint Augustinus Wilrijk
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Vergote I, Van Nieuwenhuysen E, De Waele S, Vulsteke C, Lamot C, Van den Bulck H, Claes N, Graas MP, Debrock G, Spoormans I, Vuylsteke P, Honhon B, Verhoeven D, De Maeseneer D, Dirix L, Mebis J, Vroman P, Denys H, Martinez Mena C, Pelgrims G, Van Steenberghe M, van Gorp T, Gennigens C. Prospective non-interventional BELOVA/BGOG-ov16 study on safety of frontline bevacizumab in elderly patients with FIGO stage IV ovarian cancer: a study of the Belgian and Luxembourg Gynaecological Oncology Group. Int J Gynecol Cancer. 2022 Jun 6;32(6):753-760. doi: 10.1136/ijgc-2021-003190.