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Observational Study of Bevacizumab [Avastin] in Patients With Metastatic Colorectal Cancer (AVASTART)

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:
NCT01089413
First received: March 15, 2010
Last updated: May 7, 2013
Last verified: May 2013
History of Changes

March 15, 2010
May 7, 2013
January 2010
May 2013   (final data collection date for primary outcome measure)
Observation of treatment duration in daily clinical practice [ Time Frame: Throughout study, approximately 34 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01089413 on ClinicalTrials.gov Archive Site
  • Progression-free survival in a daily clinical practice setting [ Time Frame: Throughout study, approximately 34 months ] [ Designated as safety issue: No ]
  • Identification of reasons for stopping treatment [ Time Frame: Throughout study, approximately 34 months ] [ Designated as safety issue: No ]
  • Patient and tumor characteristics: Anthropometric characteristics, performance status, medical, family and disease history [ Time Frame: Throughout study, approximately 34 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Observational Study of Bevacizumab [Avastin] in Patients With Metastatic Colorectal Cancer (AVASTART)
A Multicenter, Non-interventional, Post-authorization Study to Observe in Daily Clinical Practice the Treatment Duration of Patients Treated With Avastin (Bevacizumab) in 1st Line mCRC in Belgium

This observational study will assess the treatment duration, progression-free survival, reason for stopping treatment and patient and tumor characteristics of bevacizumab [Avastin] treatment in patients with metastatic colorectal cancer. Data will be collected for approximately 34 months. The target sample size is >300 patients.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Patients with 1st line treatment with bevacizumab in Belgium
Colorectal Cancer
Drug: bevacizumab [Avastin]
As prescribed by physician
Cohort
Intervention: Drug: bevacizumab [Avastin]
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
May 2013
May 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • adult patients =/<18 years of age
  • metastatic colorectal cancer
  • patients for whom the physician has prescribed bevacizumab [Avastin] for the treatment of 1st line metastatic colorectal cancer
  • patients, who have given written informed consent

Exclusion Criteria:

  • hypersensitivity to recombinant human or humanised antibodies
  • pregnancy or breast-feeding
Both
18 Years and older
No
Contact: Please reference Study ID Number: ML25117 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) genentechclinicaltrials@druginfo.com
Belgium
 
NCT01089413
ML25117
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
May 2013

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