Skip to main content
OpenTrials
Completed

NCT Number: NCT02393898

BELOVA Data Collection: Safety and Efficacy of Frontline Bevacizumab Treatment in Participants With Ovarian Cancer 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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Ovarian Cancer Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

70 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Onze Lieve Vrouwziekenhuis Aalst, Aalst, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bevacizumab

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.

Other names: Avastin

carboplatin

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

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.

Primary outcomes

  1. Percentage of Participants with Adverse Events

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

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

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

Secondary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

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

    Time frame: Every 3 weeks according to SmPC for up to 15 months

  6. Total Number of Bevacizumab Doses

    Time frame: Every 3 weeks according to SmPC for up to 15 months

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

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

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Mar 20, 2015
Registry last updated
Jul 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.