An Observational Study of Avastin (Bevacizumab) in Patients With Metastatic Colorectal Cancer (RELEVANT)

Hoffmann-La Roche0 sites191 target enrollmentMarch 2009

ConditionsColorectal Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Colorectal Cancer
Sponsor: Hoffmann-La Roche
Enrollment: 191
Primary Endpoint: Percentage of Participants With At Least One Adverse Event (AE)
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

This prospective observational study will evaluate the safety and efficacy of Avastin (bevacizumab) in patients with metastatic colorectal cancer. Data will be collected from patients receiving Avastin in combination with chemotherapy according to registered indication in routine clinical practice.

Registry

clinicaltrials.gov

Start Date

March 2009

End Date

August 2014

Last Updated

10 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Hoffmann-La Roche

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Adult patients, \>/= 18 years of age
•Metastatic colorectal cancer
•Prescribed to receive Avastin according to registered indication

Exclusion Criteria

•Patients not eligible for Avastin treatment according to the Summary of Product Characteristics

Outcomes

Primary Outcomes

Percentage of Participants With At Least One Adverse Event (AE)

Time Frame: Up to 65 months

An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug.

Secondary Outcomes

Percentage of Participants With Clinical Benefit of Complete Response [CR], Partial Response [PR] or Stable Disease [SD] Per Response Evaluation Criteria in Solid Tumors (RECIST)(Up to 65 months)
Percentage of Participants Who Were Resectable Postbaseline Among the Participants Who Were Unresectable at Baseline(Up to 65 months)
Percentage of Participants With Disease Progression or Death(Up to 65 months)
Progression Free Survival (PFS)(Up to 65 months)