Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02393898
Recruitment Status : Completed
First Posted : March 20, 2015
Last Update Posted : July 24, 2019
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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).

Condition or disease Intervention/treatment
Ovarian Cancer Drug: Bevacizumab Drug: Carboplatin Drug: Paclitaxel

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 76 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : April 23, 2015
Actual Primary Completion Date : June 14, 2019
Actual Study Completion Date : June 14, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer
Drug Information available for: Bevacizumab

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
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 Name: 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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02393898


Locations
Show Show 26 study locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Layout table for investigator information
Study Director: Clinical Trials Hoffmann-La Roche
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02393898    
Other Study ID Numbers: ML29515
First Posted: March 20, 2015    Key Record Dates
Last Update Posted: July 24, 2019
Last Verified: July 2019
Additional relevant MeSH terms:
Layout table for MeSH terms
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Paclitaxel
 Bevacizumab
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors