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

This study is currently recruiting participants.
Verified May 2013 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01609075
First received: May 29, 2012
Last updated: May 23, 2013
Last verified: May 2013
History of Changes
  Purpose

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.


Condition
Colorectal Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Use of Bevacizumab in the Treatment of Metastatic Colorectal Cancer (mCRC) in Italy: an Observational Cohort Study

Resource links provided by NLM:

Drug Information available for: Bevacizumab
U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 600
Study Start Date: June 2012
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01609075

Contacts
Contact: Reference Study ID Number: ML27907 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

  Show 76 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01609075     History of Changes
Other Study ID Numbers: ML27907
Study First Received: May 29, 2012
Last Updated: May 23, 2013
Health Authority: Italy: Ministry of Health

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
 Rectal Diseases
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013