An Observational Study of Avastin (Bevacizumab) in Combination With Xeloda (Capecitabine) And Oxaliplatin in Patients With Colorectal Cancer

Study Overview
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Brief Summary
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This prospective observational study will evaluate the efficacy and safety of bevacizumab in combination with capecitabine and oxaliplatin as first-line treatment in participants with colorectal cancer. Data will be collected from each participant until disease progression occurs (for up to 30 months).

Official Title
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An Open Label Study of the Effect of First Line Treatment With Bevacizumab in Combination With Capecitabine and Oxaliplatin on Progression-free Survival in Patients With Metastatic Cancer of the Colon and Rectum

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Biological: Bevacizumab
* Biological: Capecitabine
* Drug: Oxaliplatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients, >/= 18 years of age Metastatic colorectal cancer Treatment in accordance with current Summary of Product Characteristics and local guidelines Exclusion Criteria: Contraindications according to current Summary of Product Characteristics and local guidelines

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Bevacizumab<br>Participants will receive bevacizumab in combination with capecitabine and oxaliplatin. | Biological: Bevacizumab<br>* Bevacizumab administered according to prescribing information and normal clinical practice.<br>* Other names: Avastin®;Biological: Capecitabine<br>* Capecitabine administered according to prescribing information and normal clinical practice.<br>* Other names: Xeloda®;Drug: Oxaliplatin<br>* Capecitabine administered according to prescribing information and normal clinical practice.<br>* Other names: Eloxatin™;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free Survival | Progression-free survival was defined as the interval between the day of first treatment and the first documentation of disease progression or death and was assessed by the investigators according to modified Response Evaluation Criteria in Solid Tumors (RECIST). Disease progression was defined as an increase in sum of lesions size by more than 20% or new lesions. | From randomization to progression or death during the study (up to approximately 30 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response Rate (Tumor Assessments According to RECIST) | Response to treatment (Response Rate) was defined as the percentage of participants with a complete remission (CR) or partial remission (PR), and was assessed by the investigators according to modified RECIST criteria. CR was defined as disappearance of all lesions. PR was defined as a decrease in sum of lesions size by more than 30%. Response Rate = CR +PR | Up to approximately 30 months | 
| Percentage of Participants With Adverse Events | An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. | Up to approximately 30 months |