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Clinical Trials/NCT01697488
NCT01697488
Completed
Not Applicable

Non-interventional Surveillance Study (NIS) on First-line (FL) Bevacizumab (Avastin) in Combination With Carboplatin/Paclitaxel in Patients With Advanced Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer

Hoffmann-La Roche1 site in 1 country1,090 target enrollmentFebruary 2, 2012
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ConditionsPeritoneal Neoplasms

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Peritoneal Neoplasms
Sponsor
Hoffmann-La Roche
Enrollment
1090
Locations
1
Primary Endpoint
Efficacy: Progression-free survival
Status
Completed
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

This observational study will evaluate the safety, efficacy, quality of life and predictive/selection factors for Avastin (bevacizumab) in combination with carboplatin/paclitaxel in first line in patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer in clinical practice. Data of eligible patients will be collected during up to 15 months of treatment and 12 months of follow-up. A second recruitment phase has been opened to focus on patients >/= 70 years.

Registry
clinicaltrials.gov
Start Date
February 2, 2012
End Date
September 27, 2019
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •Study phase 1: Patients aged \>/= 18 years
  • •Study phase 2: Patients aged \>/= 70 years
  • •Newly diagnosed advanced epithelial ovarian cancer, fallopian tube carcinoma or primary peritoneal cancer with indication for a first-line carboplatin/paclitaxel chemotherapy in combination with Avastin

Exclusion Criteria

  • •Contraindications to Avastin according to Summary of Product Characteristics

Outcomes

Primary Outcomes

Efficacy: Progression-free survival

Time Frame: up to approximately 27 months

Safety: Incidence of adverse events

Time Frame: approximately 5 years

Secondary Outcomes

  • Quality of life: European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30/QLQ-OV28 questionnaires(up to approximately 27 months)
  • Selection criteria for first-line treatment with Avastin and carboplatin/paclitaxel: clinical/demographic patient characteristics(approximately 5 years)
  • Treatment duration(approximately 5 years)
  • Treatment discontinuations/modifications(approximately 5 years)

Study Sites (1)

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