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

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

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer

• Study Type: Observational
• Enrollment (Actual): 27

Contacts and Locations

Study Locations

• South Africa
  • Cape Town, South Africa, 7500
  • George, South Africa, 6529
  • Port Elizabeth, South Africa, 6045
  • Pretoria, South Africa, 0001
  • Vereeniging, South Africa, 1939

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with metastatic colorectal cancer without prior chemotherapy in the metastatic setting

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Cohort

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Dosage/schedule of 1st-line Avastin	approximately 3 years
Duration of treatment	approximately 3 years
Chemotherapy regimens used in clinical practice	approximately 3 years
Clinical/demographic patient characteristics at baseline	approximately 3 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Progression-free survival	approximately 3 years
Relationship between termination of Avastin treatment and time point of progression	approximately 3 years

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Actual): April 1, 2012
• Study Completion (Actual): April 1, 2012

Study Registration Dates

• First Submitted: August 22, 2012
• First Submitted That Met QC Criteria: August 27, 2012
• First Posted (Estimate): August 29, 2012

Study Record Updates

• Last Update Posted (Estimate): November 2, 2016
• Last Update Submitted That Met QC Criteria: November 1, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: ML22399