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Ovarian CancerNCT02393898

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

An observational study of Ovarian Cancer, run by Hoffmann-La Roche at 26 sites in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 70 years and older, women only
Conditions the study is for
Ovarian Cancer
What is being tested?
Bevacizumab, Carboplatin and Paclitaxel
Type of treatment
Injection or infusion
How many people
76 participants
Where
26 sitesBelgium
Study dates
23 Apr 2015to 14 Jun 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 70 years and older
  • Women only
  • No healthy volunteers
  • Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • Contraindications, warnings, and precautions for bevacizumab

Trial locations and contacts

26 sites in 1 country.

26 sites in 1 country

Belgium26 sites

  • Onze Lieve Vrouwziekenhuis Aalst

    Aalst, 9300

  • AZ Sint Lucas Brugge

    Assebroek, 8310

  • Imeldaziekenhuis

    Bonheiden, 2820

  • AZ KLINA

    Brasschaat, 2930

  • AZ Sint Jan

    Bruges, 8000

  • CHU St Pierre (St Pierre)

    Brussels, 1000

  • Cliniques Uni Ires Saint-Luc; Gynaecology

    Brussels, 1200

  • GHdC Site Notre Dame

    Charleroi, 6000

  • UZ Antwerpen

    Edegem, 2650

  • ZOL (Sint Jan)

    Genk, 3600

  • AZ Maria Middelares

    Ghent, 9000

  • AZ Sint Lucas (Sint Lucas)

    Ghent, 9000

  • UZ Gent

    Ghent, 9000

  • CH Jolimont - Lobbes (Jolimont)

    Haine-Saint-Paul, 7100

  • Jessa Zkh (Campus Virga Jesse)

    Hasselt, 3500

  • AZ Groeninge

    Kortrijk, 8500

  • UZ Leuven Gasthuisberg

    Leuven, 3000

  • Chr de La Citadelle

    Liège, 4000

  • CHU Sart-Tilman

    Liège, 4000

  • Clinique Saint-Joseph

    Liège, 4000

  • Clinique Ste-Elisabeth

    Namur, 5000

  • AZ Damiaan

    Ostend, 8400

  • AZ Nikolaas (Sint Niklaas)

    Sint-Niklaas, 9100

  • AZ Turnhout Sint Elisabeth

    Turnhout, 2300

  • CHR de Verviers - East Belgium

    Verviers, 4800

  • Sint Augustinus Wilrijk

    Wilrijk, 2610

Other trials in Belgium

About this study

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

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).

Conditions
Ovarian Cancer
Medical subject headings
Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BevacizumabDrug

    Also called Avastin

    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.

  • CarboplatinDrug

    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.

  • PaclitaxelDrug

    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.

Study groups in NCT02393898
Study groupRoleWhat they receive
Elderly Participants with Ovarian CancerElderly 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.
Receives: Drug: Bevacizumab; Drug: Carboplatin; Drug: Paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants with Adverse Events

    Measured: Per routine clinical practice during bevacizumab treatment (up to 15 months)

  2. Time to First Incidence of Adverse Events of Special Interest

    Measured: Per routine clinical practice during bevacizumab treatment (up to 15 months)

Secondary outcomes (7)

  1. Progression-Free Survival According to Response Evaluation Criteria in Solid Tumors (RECIST)

    Measured: 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)

  2. Percentage of Participants with Complete or Partial Response According to RECIST

    Measured: 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)

  3. Overall Survival

    Measured: 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)

  4. Comprehensive Geriatric Assessment Subscale Scores

    Measured: 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)

  5. Dosage of Bevacizumab in Milligrams per Kilogram (mg/kg)

    Measured: Every 3 weeks according to SmPC for up to 15 months

  6. Total Number of Bevacizumab Doses

    Measured: Every 3 weeks according to SmPC for up to 15 months

  7. Percentage of Participants by Chemotherapy Used in Combination with Bevacizumab

    Measured: Every 3 weeks per routine clinical practice for up to 18 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Mar 2015 (estimated)
  2. Study start23 Apr 2015
  3. Primary completion14 Jun 2019
  4. Study completion14 Jun 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
76 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02393898
Sponsor's protocol ID
ML29515
Status last verified
Jul 2019
First submitted
12 Mar 2015
Last updated
24 Jul 2019
Results posted
No

Publications

  • 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.

    PubMed 35063943

Questions about this trial

What is this clinical trial studying?

An observational study of Ovarian Cancer, run by Hoffmann-La Roche at 26 sites in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants with Adverse Events (time frame: Per routine clinical practice during bevacizumab treatment (up to 15 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02393898, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2019.

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