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

Use of Bevacizumab in the Treatment of Metastatic Colorectal Cancer (mCRC) in Italy: an Observational Cohort Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01609075
Enrollment
437
Registered
2012-05-31
Start date
2012-06-30
Completion date
2013-06-30
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, 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.

Interventions

None listed

Sponsors

Hoffmann-La Roche
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Proportion of patients with Avastin treatment discontinuation due to either disease progression or Avastin-related adverse eventsapproximately 15 months

Secondary

MeasureTime frame
Proportion of patients with treatment discontinuation due to other causesapproximately 15 months
Incidence of other causes for treatment discontinuationapproximately 15 months
Second-line treatments initiatedapproximately 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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026