BELOVA Data Collection: Safety and Efficacy of Frontline Bevacizumab Treatment in Participants With Ovarian Cancer 70 Years and Older
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
1 other identifier
observational
76
1 country
26
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2015
Longer than P75 for all trials
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 12, 2015
CompletedFirst Posted
Study publicly available on registry
March 20, 2015
CompletedStudy Start
First participant enrolled
April 23, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 14, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 14, 2019
CompletedJuly 24, 2019
July 1, 2019
4.1 years
March 12, 2015
July 23, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (7)
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)
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)
Dosage of Bevacizumab in Milligrams per Kilogram (mg/kg)
Every 3 weeks according to SmPC for up to 15 months
- +2 more secondary outcomes
Study Arms (1)
Elderly Participants with Ovarian Cancer
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.
Interventions
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 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 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 Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- Contraindications, warnings, and precautions for bevacizumab
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (26)
Onze Lieve Vrouwziekenhuis Aalst
Aalst, 9300, Belgium
AZ Sint Lucas Brugge
Assebroek, 8310, Belgium
Imeldaziekenhuis
Bonheiden, 2820, Belgium
AZ KLINA
Brasschaat, 2930, Belgium
AZ Sint Jan
Bruges, 8000, Belgium
CHU St Pierre (St Pierre)
Brussels, 1000, Belgium
Cliniques Uni Ires Saint-Luc; Gynaecology
Brussels, 1200, Belgium
GHdC Site Notre Dame
Charleroi, 6000, Belgium
UZ Antwerpen
Edegem, 2650, Belgium
ZOL (Sint Jan)
Genk, 3600, Belgium
AZ Maria Middelares
Ghent, 9000, Belgium
AZ Sint Lucas (Sint Lucas)
Ghent, 9000, Belgium
UZ Gent
Ghent, 9000, Belgium
CH Jolimont - Lobbes (Jolimont)
Haine-Saint-Paul, 7100, Belgium
Jessa Zkh (Campus Virga Jesse)
Hasselt, 3500, Belgium
AZ Groeninge
Kortrijk, 8500, Belgium
UZ Leuven Gasthuisberg
Leuven, 3000, Belgium
Chr de La Citadelle
Liège, 4000, Belgium
CHU Sart-Tilman
Liège, 4000, Belgium
Clinique Saint-Joseph
Liège, 4000, Belgium
Clinique Ste-Elisabeth
Namur, 5000, Belgium
AZ Damiaan
Ostend, 8400, Belgium
AZ Nikolaas (Sint Niklaas)
Sint-Niklaas, 9100, Belgium
AZ Turnhout Sint Elisabeth
Turnhout, 2300, Belgium
CHR de Verviers - East Belgium
Verviers, 4800, Belgium
Sint Augustinus Wilrijk
Wilrijk, 2610, Belgium
Related Publications (1)
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.
PMID: 35063943DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 12, 2015
First Posted
March 20, 2015
Study Start
April 23, 2015
Primary Completion
June 14, 2019
Study Completion
June 14, 2019
Last Updated
July 24, 2019
Record last verified: 2019-07