An Observational Study of Avastin (Bevacizumab) in First Line in Patients With Metastatic Colorectal Cancer (AVANiS)

Colorectal Cancer Clinical Trial

Official title:

Non-interventional Study of Avastin in 1st Line Metastatic Colorectal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01674907
• Other study ID #: ML22399
• Status: Completed
• Phase: N/A
• First received: August 22, 2012
• Last updated: November 1, 2016
• Start date: March 2010
• Est. completion date: April 2012

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Africa: Medicines Control Council of South Africa
• Study type: Observational

Clinical Trial Summary

This observational study will evaluate the use in clinical practice and the efficacy of Avastin (bevacizumab) in patients with metastatic colorectal cancer who have not received prior chemotherapy treatment in the metastatic setting. Patients for whom the treating physician has decided to initiate therapy with Avastin will be followed for 10 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients, >/= 18 years of age

• Histologically confirmed metastatic colorectal cancer without prior chemotherapy in the metastatic setting

Exclusion Criteria:

• Contraindications for Avastin according to the locally approved package insert (version 7 April 2006)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dosage/schedule of 1st-line Avastin		approximately 3 years	No
Primary	Duration of treatment		approximately 3 years	No
Primary	Chemotherapy regimens used in clinical practice		approximately 3 years	No
Primary	Clinical/demographic patient characteristics at baseline		approximately 3 years	No
Secondary	Progression-free survival		approximately 3 years	No
Secondary	Relationship between termination of Avastin treatment and time point of progression		approximately 3 years	No