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

Completed

• Conditions: Ovarian Cancer
• Interventions: Drug: Bevacizumab; Drug: Carboplatin; Drug: Paclitaxel

• Registration Number: NCT02393898
• Lead Sponsor: Hoffmann-La Roche

Brief 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. 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

Not available

Study Timeline

• Study First Submitted: 2015-03-12
• Study First Submitted QC: 2015-03-16
• Study First Posted: 2015-03-20
• Study Start: 2015-04-23
• Primary Completion: 2019-06-14
• Study Completion: 2019-06-14
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-23
• Last Update Posted: 2019-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 76

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Elderly Participants with Ovarian Cancer	Carboplatin	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.
Elderly Participants with Ovarian Cancer	Paclitaxel	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.
Elderly Participants with Ovarian Cancer	Bevacizumab	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Dosage of Bevacizumab in Milligrams per Kilogram (mg/kg)	Every 3 weeks according to SmPC for up to 15 months
Percentage of Participants with Complete or Partial Response According to RECIST	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	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	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)
Percentage of Participants by Chemotherapy Used in Combination with Bevacizumab	Every 3 weeks per routine clinical practice for up to 18 weeks
Total Number of Bevacizumab Doses	Every 3 weeks according to SmPC for up to 15 months
Progression-Free Survival According to Response Evaluation Criteria in Solid Tumors (RECIST)	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)

Trial Locations

Locations (26)

Onze Lieve Vrouwziekenhuis Aalst; 🇧🇪 Aalst, Belgium

AZ Sint Lucas Brugge; 🇧🇪 Assebroek, Belgium

Imeldaziekenhuis; 🇧🇪 Bonheiden, Belgium

AZ KLINA; 🇧🇪 Brasschaat, Belgium

AZ Sint Jan; 🇧🇪 Brugge, Belgium

CHU St Pierre (St Pierre); 🇧🇪 Brussels, Belgium

Cliniques Uni Ires Saint-Luc; Gynaecology; 🇧🇪 Bruxelles, Belgium

GHdC Site Notre Dame; 🇧🇪 Charleroi, Belgium

UZ Antwerpen; 🇧🇪 Edegem, Belgium

ZOL (Sint Jan); 🇧🇪 Genk, Belgium

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