Assessment of Clinical Practice Administration of Chemotherapy and Anti-angiogenic Agent (Bevacizumab) in Colorectal Cancer

Study Overview
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Brief Summary
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Investigators propose to assess, retrospectively (from 1/7/2009) and prospectively (up to 31/12/2013,) the safety and tolerability profile (number of participants with adverse events) of standard chemotherapy and anti-angiogenic agent bevacizumab (Avastin) as first line treatment of patients with metastatic Colorectal Cancer with or without KRAS mutation. All treatment schedules that are going to be assessed are considered by the international guidelines as standard therapy for patients with metastatic Colorectal Cancer.

Detailed Description
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In addition investigators propose to assess the compliance of patients to treatment and the efficacy of treatment. That means percentage of objective responses, duration of response, frequency of curative liver resection after the administration of treatment, progression free survival and estimation of overall survival

Official Title
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Assessment of Clinical Practice Administration of Chemotherapy and Anti-angiogenic Agent (Bevacizumab) Retrospectively (From 1/7/2009) and Prospectively (up to 31/12/2013) as First Line Treatment for Patients With Locally Advanced or Metastatic Colorectal Cancer (With or Without KRAS Mutation). Assessment of Toxicity, Compliance and Survival of Patients.

Conditions
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Metastatic Colorectal Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent Histologically confirmed metastatic or locally advanced non-operable colorectal cancer No prior first line treatment for metastatic colorectal cancer Age ≥18 years One or more measurable lesions (≥1cm in diameter with spiral CT scan or ≥2cm with conventional techniques) according to RECIST criteria ECOG performance status ≤2 Adequate haematological, renal and hepatic function Urine protein <2+ (dipstick) Life expectancy of ≥12 weeks Exclusion Criteria: Previous first line treatment for metastatic colorectal cancer(progression >6 months after the end of adjuvant treatment) Previous radiotherapy to target lesions Patients with brain metastases and/or cancerous meningitis Metastatic infiltration >50% of the liver parenchyma Presence or history of other neoplasm except properly treated basal cell skin cancer or in situ cervical carcinoma Patients participating in interventional clinical trial

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 |
| --- | --- |
| Avastin regimens<br>Patients who have either received or who are going to receive chemotherapy plus Avastin (bevacizumab) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with AE | In this observational study investigators are going to assess standard schedules in which administration was every 2 weeks. | Every 2 weeks up to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Response Rate | In this observational study investigators are going to assess standard schedules in which the disease evaluation was performed every 6 weeks | Disease evaluation at Week 6 | 
| Percentage of Patients with Progression Free Survival |  | 1 year | 
| Patients Overall Survival |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mCRC, KRAS mutation, Chemotherapy, Anti-angiogenic agent, Bevacizumab, 1st Line