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

Hoffmann-La Roche68 enrolled

Overview

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).

Study Type

OBSERVATIONAL

Enrollment

Conditions

Colorectal Cancer

Interventions

BevacizumabBIOLOGICAL

Bevacizumab administered according to prescribing information and normal clinical practice.

CapecitabineBIOLOGICAL

Capecitabine administered according to prescribing information and normal clinical practice.

OxaliplatinDRUG

Capecitabine administered according to prescribing information and normal clinical practice.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (9)

Unnamed facility

Banská Bystrica, Slovakia

Unnamed facility

Bratislava, Slovakia

Unnamed facility

Bratislava, Slovakia

Unnamed facility

Košice, Slovakia

Outcomes

Primary Outcomes

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.

Time frame: From randomization to progression or death during the study (up to approximately 30 months)

Secondary Outcomes

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

Time frame: 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.

Time frame: Up to approximately 30 months

Data from ClinicalTrials.gov

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