BEVERLY-C: An Observational Study of Avastin (Bevacizumab) in First-Line Treatment in Elderly Patients With Metastatic Colorectal Cancer
Completed
- Conditions
- Colorectal Cancer
- Registration Number
- NCT01791140
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This observational study will evaluate the efficacy and safety of Avastin (bevacizumab) in combination with fluoropyrimidine-based chemotherapy in elderly patients (\>/= 65 years of age) with newly diagnosed metastatic colorectal cancer. Patients will be followed until disease progression, death, withdrawal of consent, discontinuation of physician-patient relationship or study closure, whichever comes first.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3
Inclusion Criteria
- Adult patients, >/= 65 years of age
- Patients with newly diagnosed metastatic colorectal cancer starting first-line treatment with Avastin in combination with fluoropyrimidine-based chemotherapy according to the approved Hungarian Summary of Product Characteristics
- Patients suitable for Avastin treatment as assessed by the treating physician
Exclusion Criteria
- Any contraindications to Avastin treatment according to the Hungarian Summary of Product Characteristics
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Median progression-free survival approximately 3.5 years
- Secondary Outcome Measures
Name Time Method Overall response rate (complete response + partial response) approximately 3.5 years Clinical benefit rate (complete response + partial response + stable disease) approximately 3.5 years Metastasectomy rate approximately 3.5 years Mean duration of Avastin treatment approximately 3.5 years Safety: Incidence of adverse events approximately 3.5 years Median progression-free survival in subgroup receiving Avastin plus fluorouracil monotherapy approximately 3.5 years Median progression-free survival according to age group (65-74 years; >/= 75 years) approximately 3.5 years