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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01609075
• Other study ID #: ML27907
• Status: Completed
• Phase: N/A
• First received: May 29, 2012
• Last updated: November 1, 2016
• Start date: June 2012
• Est. completion date: June 2013

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 437
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with Avastin treatment discontinuation due to either disease progression or Avastin-related adverse events		approximately 15 months	No
Secondary	Proportion of patients with treatment discontinuation due to other causes		approximately 15 months	No
Secondary	Incidence of other causes for treatment discontinuation		approximately 15 months	No
Secondary	Second-line treatments initiated		approximately 15 months	No
Secondary	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	No