An Observational Study of Avastin and Conventional Chemotherapy in Patients >/= 70 Years of Age With Previously Untreated Metastatic Colorectal Cancer (AVAPLUS)

Tracking Information
First Submitted Date	August 27, 2012
First Posted Date	August 31, 2012
Last Update Posted Date	November 2, 2016
Study Start Date	August 2011
Actual Primary Completion Date	May 2015 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures; (submitted: August 30, 2012)	Treatment duration in patients receiving chemotherapy with Avastin as first-line therapy in daily clinical practice [ Time Frame: approximately 24 months ]
Original Primary Outcome Measures	Same as current
Change History	Complete list of historical versions of study NCT01676922 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures; (submitted: August 30, 2012)	Treatment duration in patients receiving chemotherapy alone as first-line therapy in daily clinical practice [ Time Frame: approximately 24 months ]; Safety: Incidence of adverse events/adverse events of special interest [ Time Frame: approximately 24 months ]; Clinical/demographic patient characteristics at baseline [ Time Frame: approximately 24 months ]; Dosage/regimen [ Time Frame: approximately 24 months ]; Correlation between Comprehensive Geriatric Assessment (CGA) scores and initial treatment [ Time Frame: approximately 24 months ]
Original Secondary Outcome Measures	Same as current
Current Other Outcome Measures	Not Provided
Original Other Outcome Measures	Not Provided
Descriptive Information
Brief Title	An Observational Study of Avastin and Conventional Chemotherapy in Patients >/= 70 Years of Age With Previously Untreated Metastatic Colorectal Cancer (AVAPLUS)
Official Title	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
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).
Detailed Description	Not Provided
Study Type	Observational
Study Design	Observational Model: Cohort; Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Probability Sample
Study Population	Patients >/= 70 years of age with previously untreated metastatic colorectal cancer suitable to receive chemotherapy with or without Avastin
Condition	Colorectal Cancer
Intervention	Not Provided
Study Groups/Cohorts	Cohort
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status	Completed
Actual Enrollment; (submitted: March 17, 2014)	256
Original Estimated Enrollment; (submitted: August 30, 2012)	200200
Actual Study Completion Date	May 2015
Actual Primary Completion Date	May 2015 (Final data collection date for primary outcome measure)
Eligibility Criteria	Inclusion Criteria: Adult patients, >/ 70 years of age; Previously untreated metastatic colorectal cancer; Patient considered suitable to receive chemotherapy with or without Avastin Exclusion Criteria: Participation in any other clinical trial or study with the exception of participation in registries
Sex/Gender	Sexes Eligible for Study: All
Ages	70 Years and older (Senior)
Accepts Healthy Volunteers	No
Contacts	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries	Belgium
Removed Location Countries	Russian Federation
Administrative Information
NCT Number	NCT01676922
Other Study ID Numbers	ML27768
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Hoffmann-La Roche
Study Sponsor	Hoffmann-La Roche
Collaborators	Not Provided
Investigators	Study Director: Clinical Trials Hoffmann-La Roche
PRS Account	Hoffmann-La Roche
Verification Date	November 2016