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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 23, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 14, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 14, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 12, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 16, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 20, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 24, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 23, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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