An Observational Study of Avastin (Bevacizumab) in Patients With Metastatic Colorectal Cancer in Italy (BEWARE)

Completed

• Conditions: Colorectal Cancer

• Registration Number: NCT01609075
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

This observational, multicenter, retrospective/prospective study will evaluate the use of Avastin (bevacizumab) in clinical practice in patients with metastatic colorectal cancer. Patients having initiated first-line treatment with a fluoropyrimidine-based chemotherapy and Avastin will be followed for up to 15 months.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-05-29
• Study First Submitted QC: 2012-05-29
• Study First Posted: 2012-05-31
• Study Start: 2012-06
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 437

Inclusion Criteria

• Adult patients, >/= 18 years of age
• Metastatic colorectal cancer
• Having initiated first-line treatment with fluoropyrimidine-based chemotherapy plus Avastin between 1. September 2011 and 29. February 2012
• Availability of test fro K-RAS genotyping

Exclusion Criteria

• Participation in a clinical trial during treatment with Avastin

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of patients with Avastin treatment discontinuation due to either disease progression or Avastin-related adverse events	approximately 15 months

Secondary Outcome Measures

Name	Time	Method
Proportion of patients with treatment discontinuation due to other causes	approximately 15 months
Incidence of other causes for treatment discontinuation	approximately 15 months
Second-line treatments initiated	approximately 15 months
Progression-free survival (patients with treatment discontinuation due to disease progression or Avastin-related toxicity as compared to patients with treatment discontinuation due to other causes)	approximately 15 months