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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01609075
First received: May 29, 2012
Last updated: October 20, 2014
Last verified: October 2014

May 29, 2012
October 20, 2014
June 2012
June 2013   (final data collection date for primary outcome measure)
Proportion of patients with Avastin treatment discontinuation due to either disease progression or Avastin-related adverse events [ Time Frame: approximately 15 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01609075 on ClinicalTrials.gov Archive Site
  • Proportion of patients with treatment discontinuation due to other causes [ Time Frame: approximately 15 months ] [ Designated as safety issue: No ]
  • Incidence of other causes for treatment discontinuation [ Time Frame: approximately 15 months ] [ Designated as safety issue: No ]
  • Second-line treatments initiated [ Time Frame: approximately 15 months ] [ Designated as safety issue: No ]
  • 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) [ Time Frame: approximately 15 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Patients with metastatic colorectal cancer having initiated first-line treatment with fluoropyrimidine-based chemotherapy and Avastin

Colorectal Cancer
Not Provided
Cohort
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
437
June 2013
June 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01609075
ML27907
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP