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

July 23, 2019 updated by: Hoffmann-La Roche

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

76

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Aalst, Belgium, 9300
        • Onze Lieve Vrouwziekenhuis Aalst
      • Assebroek, Belgium, 8310
        • AZ Sint Lucas Brugge
      • Bonheiden, Belgium, 2820
        • Imeldaziekenhuis
      • Brasschaat, Belgium, 2930
        • AZ Klina
      • Brugge, Belgium, 8000
        • AZ Sint Jan
      • Brussels, Belgium, 1000
        • CHU St Pierre (St Pierre)
      • Bruxelles, Belgium, 1200
        • Cliniques Uni Ires Saint-Luc; Gynaecology
      • Charleroi, Belgium, 6000
        • GHdC Site Notre Dame
      • Edegem, Belgium, 2650
        • UZ Antwerpen
      • Genk, Belgium, 3600
        • ZOL (Sint Jan)
      • Gent, Belgium, 9000
        • UZ Gent
      • Gent, Belgium, 9000
        • AZ Maria Middelares
      • Gent, Belgium, 9000
        • AZ Sint Lucas (Sint Lucas)
      • Haine-Saint-Paul, Belgium, 7100
        • CH Jolimont - Lobbes (Jolimont)
      • Hasselt, Belgium, 3500
        • Jessa Zkh (Campus Virga Jesse)
      • Kortrijk, Belgium, 8500
        • AZ Groeninge
      • Leuven, Belgium, 3000
        • UZ Leuven Gasthuisberg
      • Liège, Belgium, 4000
        • CHU Sart-Tilman
      • Liège, Belgium, 4000
        • CHR de la Citadelle
      • Liège, Belgium, 4000
        • Clinique Saint-Joseph
      • Namur, Belgium, 5000
        • Clinique Ste-Elisabeth
      • Oostende, Belgium, 8400
        • AZ Damiaan
      • Sint Niklaas, Belgium, 9100
        • AZ Nikolaas (Sint Niklaas)
      • Turnhout, Belgium, 2300
        • AZ Turnhout Sint Elisabeth
      • Verviers, Belgium, 4800
        • CHR de Verviers - East Belgium
      • Wilrijk, Belgium, 2610
        • Sint Augustinus Wilrijk

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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.
Other Names:
  • Avastin
Drug: 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.
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants with Adverse Events
Time Frame: Per routine clinical practice during bevacizumab treatment (up to 15 months)
Per routine clinical practice during bevacizumab treatment (up to 15 months)
Time to First Incidence of Adverse Events of Special Interest
Time Frame: Per routine clinical practice during bevacizumab treatment (up to 15 months)
Per routine clinical practice during bevacizumab treatment (up to 15 months)

Secondary Outcome Measures

Outcome Measure
Time Frame
Progression-Free Survival According to Response Evaluation Criteria in Solid Tumors (RECIST)
Time Frame: 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)
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
Time Frame: 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)
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
Time Frame: 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)
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
Time Frame: 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)
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)
Time Frame: Every 3 weeks according to SmPC for up to 15 months
Every 3 weeks according to SmPC for up to 15 months
Total Number of Bevacizumab Doses
Time Frame: Every 3 weeks according to SmPC for up to 15 months
Every 3 weeks according to SmPC for up to 15 months
Percentage of Participants by Chemotherapy Used in Combination with Bevacizumab
Time Frame: Every 3 weeks per routine clinical practice for up to 18 weeks
Every 3 weeks per routine clinical practice for up to 18 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 23, 2015

Primary Completion (Actual)

June 14, 2019

Study Completion (Actual)

June 14, 2019

Study Registration Dates

First Submitted

March 12, 2015

First Submitted That Met QC Criteria

March 16, 2015

First Posted (Estimate)

March 20, 2015

Study Record Updates

Last Update Posted (Actual)

July 24, 2019

Last Update Submitted That Met QC Criteria

July 23, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML29515

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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