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
1 other identifier
observational
201
1 country
19
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2010
Typical duration for all trials
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedFirst Submitted
Initial submission to the registry
March 15, 2010
CompletedFirst Posted
Study publicly available on registry
March 18, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedResults Posted
Study results publicly available
December 16, 2015
CompletedDecember 16, 2015
November 1, 2015
3.4 years
March 15, 2010
November 13, 2015
November 13, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Duration of Bevacizumab Treatment
Duration of bevacizumab treatment (in months) was defined as: (last treatment date - first treatment date plus \[+\] 1)/30.44. Duration of treatment was estimated using Kaplan-Meier method. Results are reported as per age groups (\<70 years and greater than or equal to \[≥\] 70 years) as well as for overall participants.
Baseline up to end of treatment (up to approximately 3 years)
Secondary Outcomes (3)
Progression-Free Survival (PFS)
Baseline up to disease progression or death (up to approximately 3 years)
Percentage of Participants With Best Overall Response
Baseline up to disease progression or death (up to approximately 3 years)
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Baseline up to Cycle 51 (1 cycle = 21 days)
Study Arms (1)
Cohort
Interventions
Eligibility Criteria
Patients with 1st line treatment with bevacizumab in Belgium
You may qualify if:
- 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
You may not qualify if:
- hypersensitivity to recombinant human or humanised antibodies
- pregnancy or breast-feeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
Unknown Facility
Aalst, 9300, Belgium
Unknown Facility
Antwerp, 2020, Belgium
Unknown Facility
Assebroek, 8310, Belgium
Unknown Facility
Aye, 6900, Belgium
Unknown Facility
Bruges, 8000, Belgium
Unknown Facility
Brussels, 1180, Belgium
Unknown Facility
Charleroi, 6000, Belgium
Unknown Facility
Haine-Saint-Paul, 7100, Belgium
Unknown Facility
Hasselt, 3500, Belgium
Unknown Facility
Ieper, 8900, Belgium
Unknown Facility
Kortrijk, 8500, Belgium
Unknown Facility
Liège, 4000, Belgium
Unknown Facility
Mons, 7000, Belgium
Unknown Facility
Namur, 5000, Belgium
Unknown Facility
Roeselare, 8800, Belgium
Unknown Facility
Sint-Niklaas, 9100, Belgium
Unknown Facility
Tongeren, 3700, Belgium
Unknown Facility
Tournai, 7500, Belgium
Unknown Facility
Vilvoorde, 1800, Belgium
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffman-La Roche
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
March 15, 2010
First Posted
March 18, 2010
Study Start
January 1, 2010
Primary Completion
June 1, 2013
Study Completion
June 1, 2013
Last Updated
December 16, 2015
Results First Posted
December 16, 2015
Record last verified: 2015-11