An Observational Study of Avastin and Conventional Chemotherapy in Patients >/= 70 Years of Age With Previously Untreated Metastatic Colorectal Cancer (AVAPLUS)
Prospective Non-interventional Study to Collect Data on the Use of Avastin and Conventional Chemotherapy for the Treatment of Previously Untreated Metastatic Colorectal Cancer in Patients >/= 70 Years
1 other identifier
observational
256
1 country
33
Brief Summary
This observational study will evaluate the use of Avastin (bevacizumab) and conventional chemotherapy in patients \>/= 70 years of age with previously untreated metastatic colorectal cancer. Data will be collected from each patient from initiation of treatment until disease progression occurs (minimum follow-up 12 months).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2011
Typical duration for all trials
33 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
August 1, 2011
CompletedFirst Submitted
Initial submission to the registry
August 27, 2012
CompletedFirst Posted
Study publicly available on registry
August 31, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedNovember 2, 2016
November 1, 2016
3.8 years
August 27, 2012
November 1, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Treatment duration in patients receiving chemotherapy with Avastin as first-line therapy in daily clinical practice
approximately 24 months
Secondary Outcomes (5)
Treatment duration in patients receiving chemotherapy alone as first-line therapy in daily clinical practice
approximately 24 months
Safety: Incidence of adverse events/adverse events of special interest
approximately 24 months
Clinical/demographic patient characteristics at baseline
approximately 24 months
Dosage/regimen
approximately 24 months
Correlation between Comprehensive Geriatric Assessment (CGA) scores and initial treatment
approximately 24 months
Study Arms (1)
Cohort
Eligibility Criteria
Patients \>/= 70 years of age with previously untreated metastatic colorectal cancer suitable to receive chemotherapy with or without Avastin
You may qualify if:
- Adult patients, \>/ 70 years of age
- Previously untreated metastatic colorectal cancer
- Patient considered suitable to receive chemotherapy with or without Avastin
You may not qualify if:
- Participation in any other clinical trial or study with the exception of participation in registries
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (33)
Unknown Facility
Aalst, 9300, Belgium
Unknown Facility
Antwerp, 2020, Belgium
Unknown Facility
Assebroek, 8310, Belgium
Unknown Facility
Bonheiden, 2820, Belgium
Unknown Facility
Bornem, 2880, Belgium
Unknown Facility
Brasschaat, 2930, Belgium
Unknown Facility
Bruges, 8000, Belgium
Unknown Facility
Brussels, 1070, Belgium
Unknown Facility
Brussels, 1090, Belgium
Unknown Facility
Brussels, 1200, Belgium
Unknown Facility
Ghent, 9000, Belgium
Unknown Facility
Haine-Saint-Paul, 7100, Belgium
Unknown Facility
Hasselt, 3500, Belgium
Unknown Facility
Hornu, 7301, Belgium
Unknown Facility
Ieper, 8900, Belgium
Unknown Facility
Kortrijk, 8500, Belgium
Unknown Facility
Leuven, 3000, Belgium
Unknown Facility
Lier, 2500, Belgium
Unknown Facility
Liège, 4000, Belgium
Unknown Facility
Mechelen, 2800, Belgium
Unknown Facility
Mons, 7000, Belgium
Unknown Facility
Mont-godinne, 5530, Belgium
Unknown Facility
Namur, 5000, Belgium
Unknown Facility
Ostend, 8400, Belgium
Unknown Facility
Oudenaarde, 9700, Belgium
Unknown Facility
Roeselare, 8800, Belgium
Unknown Facility
Ronse, 9600, Belgium
Unknown Facility
Seraing, 4100, Belgium
Unknown Facility
Sint-Niklaas, 9100, Belgium
Unknown Facility
Tongeren, 3700, Belgium
Unknown Facility
Turnhout, 2300, Belgium
Unknown Facility
Verviers, 4800, Belgium
Unknown Facility
Wilrijk, 2610, Belgium
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 27, 2012
First Posted
August 31, 2012
Study Start
August 1, 2011
Primary Completion
May 1, 2015
Study Completion
May 1, 2015
Last Updated
November 2, 2016
Record last verified: 2016-11