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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01697449
First received: September 28, 2012
Last updated: May 7, 2013
Last verified: May 2013
History of Changes
  Purpose

This prospective observational study will evaluate the safety and efficacy of Avastin (bevacizumab) in patients with metastatic colorectal cancer. Data will be collected from patients receiving Avastin in combination with chemotherapy according to registered indication in routine clinical practice.


Condition
Colorectal Cancer

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Safety: Incidence of adverse events [ Time Frame: approximately 4.5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Response rate (including rate of primary unresectable patients reaching stage of resectability) [ Time Frame: approximately 4.5 years ] [ Designated as safety issue: No ]
  • Progression-free survival [ Time Frame: approximately 4.5 years ] [ Designated as safety issue: No ]

Enrollment: 197
Study Start Date: March 2009
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 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 initiated on Avastin in combination with chemotherapy

Criteria

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Metastatic colorectal cancer
  • Prescribed to receive Avastin according to registered indication

Exclusion Criteria:

  • Patients not eligible for Avastin treatment according to the Summary of Product Characteristics
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01697449

Locations
Serbia
Belgrade, Serbia, 11000
Belgrade, Serbia, 11080
Kragujevac, Serbia, 34000
NIS, Serbia, 18000
Sremska Kamenica, Serbia, 21204
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: NCT01697449     History of Changes
Other Study ID Numbers: ML21889
Study First Received: September 28, 2012
Last Updated: May 7, 2013
Health Authority: Serbia: Medicines and Medical Devices Agency

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

ClinicalTrials.gov processed this record on May 19, 2013