A Non-interventional Multicenter Study of First-line Avastin® (Bevacizumab) in Combination With Chemotherapy in Patients With Metastatic Colorectal Cancer

Hoffmann-La Roche14 sites in 1 country205 target enrollmentSeptember 3, 2010

ConditionsColorectal Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Colorectal Cancer
Sponsor: Hoffmann-La Roche
Enrollment: 205
Locations: 14
Primary Endpoint: Progression-free survival in a real life setting assessed by computer tomography
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This observational study will assess the progression-free survival, overall response and safety of Avastin (bevacizumab) in combination with chemotherapy in a real life setting in patients with metastatic colorectal cancer. Data will be collected from patients for approximately 2 years.

Registry

clinicaltrials.gov

Start Date

September 3, 2010

End Date

July 10, 2015

Last Updated

8 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Hoffmann-La Roche

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Adult patients, age \>/=18 years
•Proven metastatic colorectal carcinoma
•Patients have measurable disease
•Patients are eligible to receive first-line Avastin
•Patients have signed data release form

Exclusion Criteria

•Contra-indication to receive Avastin according to the local labeling
•Participation in a clinical study within 30 days prior to enrolment
•Patients have any other primary cancer
•Concomitant treatment with other biologics
•History of other malignant disease in the past 5 years except basal cell carcinoma

Outcomes

Primary Outcomes

Progression-free survival in a real life setting assessed by computer tomography

Time Frame: Approximately 2 years

Secondary Outcomes

Overall response rate assessed by computer tomography(Approximately 2 years)
Response of Avastin according to the sites of metastases assessed by computer tomography(Approximately 2 years)
Chemotherapy regimens used in combination with Avastin(Approximately 2 years)
Patient demographics eligible to receive Avastin(Approximately 2 years)
Safety: incidence of adverse events(Approximately 2 years)