Clinical trial NCT01676922: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2012-08-31
Enrollment: 256
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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).


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

Primary outcomes:
measure: Treatment duration in patients receiving chemotherapy with Avastin as first-line therapy in daily clinical practice
timeFrame: approximately 24 months
Secondary outcomes:
measure: Treatment duration in patients receiving chemotherapy alone as first-line therapy in daily clinical practice
timeFrame: approximately 24 months
measure: Safety: Incidence of adverse events/adverse events of special interest
timeFrame: approximately 24 months
measure: Clinical/demographic patient characteristics at baseline
timeFrame: approximately 24 months
measure: Dosage/regimen
timeFrame: approximately 24 months
measure: Correlation between Comprehensive Geriatric Assessment (CGA) scores and initial treatment
timeFrame: approximately 24 months
Other outcomes:
Locations:
city: Aalst
country: Belgium
city: Antwerpen
country: Belgium
city: Assebroek
country: Belgium
city: Bonheiden
country: Belgium
city: Bornem
country: Belgium
city: Brasschaat
country: Belgium
city: Brugge
country: Belgium
city: Brussel
country: Belgium
city: Bruxelles
country: Belgium
city: Bruxelles
country: Belgium
city: Gent
country: Belgium
city: Haine-Saint-Paul
country: Belgium
city: Hasselt
country: Belgium
city: Hornu
country: Belgium
city: Ieper
country: Belgium
city: Kortrijk
country: Belgium
city: Leuven
country: Belgium
city: Lier
country: Belgium
city: Liège
country: Belgium
city: Mechelen
country: Belgium
city: Mons
country: Belgium
city: Mont-godinne
country: Belgium
city: Namur
country: Belgium
city: Oostende
country: Belgium
city: Oudenaarde
country: Belgium
city: Roeselare
country: Belgium
city: Ronse
country: Belgium
city: Seraing
country: Belgium
city: Sint-Niklaas
country: Belgium
city: Tongeren
country: Belgium
city: Turnhout
country: Belgium
city: Verviers
country: Belgium
city: Wilrijk
country: Belgium
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: