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

NCT ID: NCT02393898

Last Updated: 2019-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

76 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-04-23

Study Completion Date

2019-06-14

Brief Summary

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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).

Detailed Description

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Conditions

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Ovarian Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Bevacizumab

Intervention Type DRUG

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

Intervention Type DRUG

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

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Avastin

Eligibility Criteria

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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
Minimum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Onze Lieve Vrouwziekenhuis Aalst

Aalst, , Belgium

Site Status

AZ Sint Lucas Brugge

Assebroek, , Belgium

Site Status

Imeldaziekenhuis

Bonheiden, , Belgium

Site Status

AZ KLINA

Brasschaat, , Belgium

Site Status

AZ Sint Jan

Bruges, , Belgium

Site Status

CHU St Pierre (St Pierre)

Brussels, , Belgium

Site Status

Cliniques Uni Ires Saint-Luc; Gynaecology

Brussels, , Belgium

Site Status

GHdC Site Notre Dame

Charleroi, , Belgium

Site Status

UZ Antwerpen

Edegem, , Belgium

Site Status

ZOL (Sint Jan)

Genk, , Belgium

Site Status

AZ Maria Middelares

Ghent, , Belgium

Site Status

AZ Sint Lucas (Sint Lucas)

Ghent, , Belgium

Site Status

UZ Gent

Ghent, , Belgium

Site Status

CH Jolimont - Lobbes (Jolimont)

Haine-Saint-Paul, , Belgium

Site Status

Jessa Zkh (Campus Virga Jesse)

Hasselt, , Belgium

Site Status

AZ Groeninge

Kortrijk, , Belgium

Site Status

UZ Leuven Gasthuisberg

Leuven, , Belgium

Site Status

Chr de La Citadelle

Liège, , Belgium

Site Status

CHU Sart-Tilman

Liège, , Belgium

Site Status

Clinique Saint-Joseph

Liège, , Belgium

Site Status

Clinique Ste-Elisabeth

Namur, , Belgium

Site Status

AZ Damiaan

Ostend, , Belgium

Site Status

AZ Nikolaas (Sint Niklaas)

Sint-Niklaas, , Belgium

Site Status

AZ Turnhout Sint Elisabeth

Turnhout, , Belgium

Site Status

CHR de Verviers - East Belgium

Verviers, , Belgium

Site Status

Sint Augustinus Wilrijk

Wilrijk, , Belgium

Site Status

Countries

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Belgium

References

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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.

Reference Type DERIVED
PMID: 35063943 (View on PubMed)

Other Identifiers

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ML29515

Identifier Type: -

Identifier Source: org_study_id

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