An Observational Study of Avastin (Bevacizumab) in Patients With Metastatic Colorectal Cancer (RELEVANT)
1 other identifier
observational
191
1 country
5
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2009
Longer than P75 for all trials
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2009
CompletedFirst Submitted
Initial submission to the registry
September 28, 2012
CompletedFirst Posted
Study publicly available on registry
October 2, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedResults Posted
Study results publicly available
October 16, 2015
CompletedOctober 16, 2015
September 1, 2015
5.4 years
September 28, 2012
September 15, 2015
September 15, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With At Least One Adverse Event (AE)
An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug.
Up to 65 months
Secondary Outcomes (4)
Percentage of Participants With Clinical Benefit of Complete Response [CR], Partial Response [PR] or Stable Disease [SD] Per Response Evaluation Criteria in Solid Tumors (RECIST)
Up to 65 months
Percentage of Participants Who Were Resectable Postbaseline Among the Participants Who Were Unresectable at Baseline
Up to 65 months
Percentage of Participants With Disease Progression or Death
Up to 65 months
Progression Free Survival (PFS)
Up to 65 months
Study Arms (1)
Cohort
Eligibility Criteria
Patients with metastatic colorectal cancer initiated on Avastin in combination with chemotherapy
You may qualify if:
- Adult patients, \>/= 18 years of age
- Metastatic colorectal cancer
- Prescribed to receive Avastin according to registered indication
You may not qualify if:
- Patients not eligible for Avastin treatment according to the Summary of Product Characteristics
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Unknown Facility
Belgrade, 11000, Serbia
Unknown Facility
Belgrade, 11080, Serbia
Unknown Facility
Kamenitz, 21204, Serbia
Unknown Facility
Kragujevac, 34000, Serbia
Unknown Facility
Niš, 18000, Serbia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-LaRoche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 28, 2012
First Posted
October 2, 2012
Study Start
March 1, 2009
Primary Completion
August 1, 2014
Study Completion
August 1, 2014
Last Updated
October 16, 2015
Results First Posted
October 16, 2015
Record last verified: 2015-09