BEVERLY-C: An Observational Study of Avastin (Bevacizumab) in First-Line Treatment in Elderly Patients With Metastatic Colorectal Cancer

Program for Assessment of Activity and Safety of 1st-line Bevacizumab (Avastin) Therapy in Elderly Patients With Metastatic Colorectal Cancer (BEVERLY-C Study)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01791140

Enrollment

Registered

2013-02-13

Start date

2011-03-31

Completion date

2011-05-31

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

65 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Median progression-free survival	approximately 3.5 years

Secondary

Measure	Time frame
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
Overall response rate (complete response + partial response)	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
Safety: Incidence of adverse events	approximately 3.5 years

Countries

Hungary

Outcome results