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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01089413
First received: March 15, 2010
Last updated: July 7, 2014
Last verified: July 2014
  Purpose

This observational study will assess the treatment duration, progression-free su rvival, reason for stopping treatment and patient and tumor characteristics of b evacizumab [Avastin] treatment in patients with metastatic colorectal cancer. Da ta will be collected for approximately 34 months. The target sample size is >300 patients.


Condition Intervention
Colorectal Cancer
Drug: bevacizumab [Avastin]

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Observation of treatment duration in daily clinical practice [ Time Frame: Throughout study, approximately 34 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 202
Study Start Date: January 2010
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Cohort Drug: bevacizumab [Avastin]
As prescribed by physician

  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 1st line treatment with bevacizumab in Belgium

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01089413

Locations
Belgium
Aalst, Belgium, 9300
Antwerpen, Belgium, 2020
Assebroek, Belgium, 8310
AYE, Belgium, 6900
Brugge, Belgium, 8000
Bruxelles, Belgium, 1180
Charleroi, Belgium, 6000
Haine-saint-paul, Belgium, 7100
Hasselt, Belgium, 3500
Ieper, Belgium, 8900
Kortrijk, Belgium, 8500
Liege, Belgium, 4000
Mons, Belgium, 7000
Namur, Belgium, 5000
Roeselare, Belgium, 8800
Sint-Niklaas, Belgium, 9100
Tongeren, Belgium, 3700
Tournai, Belgium, 7500
Vilvoorde, Belgium, 1800
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: NCT01089413     History of Changes
Other Study ID Numbers: ML25117
Study First Received: March 15, 2010
Last Updated: July 7, 2014
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

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 July 20, 2014