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

November 1, 2016 updated by: Hoffmann-La Roche

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

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.

Study Overview

Status

Completed

Conditions

Colorectal Cancer

Study Type

Observational

Enrollment (Actual)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Hungary
- - Budapest, Hungary, 1145

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

61 years and older (Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Elderly patients (</= 65 years of age) with newly diagnosed metastatic colorectal cancer starting first-line treatment with Avastin in combination with fluoropyrimidine-based chemotherapy

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Cohort
Time Perspectives: Prospective

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
Cohort

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Median progression-free survival Time Frame: approximately 3.5 years	approximately 3.5 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Overall response rate (complete response + partial response) Time Frame: approximately 3.5 years	approximately 3.5 years
Clinical benefit rate (complete response + partial response + stable disease) Time Frame: approximately 3.5 years	approximately 3.5 years
Metastasectomy rate Time Frame: approximately 3.5 years	approximately 3.5 years
Mean duration of Avastin treatment Time Frame: approximately 3.5 years	approximately 3.5 years
Safety: Incidence of adverse events Time Frame: approximately 3.5 years	approximately 3.5 years
Median progression-free survival in subgroup receiving Avastin plus fluorouracil monotherapy Time Frame: approximately 3.5 years	approximately 3.5 years
Median progression-free survival according to age group (65-74 years; >/= 75 years) Time Frame: approximately 3.5 years	approximately 3.5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)