Avastin (Bevacizumab) in the Treatment of Metastatic Colorectal Cancer in Normal Clinical Use in the UK Population

Study Overview
=================
Brief Summary
-----------------
This study will focus on participants in the United Kingdom (UK) to collect local data on the effectiveness and safety of bevacizumab (Avastin) in the treatment of metastatic colorectal cancer in normal clinical use.

Official Title
-----------------
An Observational Study to Investigate the Real World Effectiveness of Avastin (Bevacizumab) in the Treatment of Metastatic Colorectal Cancer in the UK

Conditions
-----------------
Metastatic Colorectal Cancer

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have been diagnosed with metastatic colorectal cancer (mCRC) Have a Performance Status (PS) of 0-2, according to the Eastern Cooperative Oncology Group (ECOG) criteria at initiation of bevacizumab treatment Be chemotherapy-naive at diagnosis of mCRC or have relapsed more than 12 months after receiving adjuvant chemotherapy for early stage colorectal cancer Have received standard fluoropyrimidine-based chemotherapy for first-line treatment of mCRC with or without bevacizumab Have sufficient medical records available for assessment of eligibility at the Christie Hospital National Health Service (NHS) Trust, Manchester, United Kingdom For Cohort 1 (post CDF funding availability): patients between 2010-2013 who received bevacizumab with first-line chemotherapy For Cohort 2 (pre Cancer Drugs Fund [CDF] funding availability): patients propensity matched to cohort 1 between 2005-2008 who did not receive bevacizumab with first-line chemotherapy Exclusion Criteria: Subjects with metastatic colorectal cancer, who have received bevacizumab via a clinical trial Subjects with metastatic colorectal cancer, whose medical records are not complete enough to confirm eligibility for the study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort 1: bevacizumab<br>Participants with metastatic colorectal cancer between 2010-2013, who received bevacizumab (25 mg/ml concentrate for solution for infusion) with first-line chemotherapy. | Other: No intervention<br>* No intervention administered in this study<br>|
| Cohort 2: no bevacizumab<br>Participants with metastatic colorectal cancer between 2005-2008, who did not receive bevacizumab with first-line chemotherapy. | Other: No intervention<br>* No intervention administered in this study<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival (OS) |  | From date of metastatic colorectal cancer diagnosis to date of death up to 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response Rate (RR) |  | From date of metastatic colorectal cancer diagnosis to end of study up to 3 years | 
| Progression Free Survival (PFS) |  | From date of metastatic colorectal cancer diagnosis to end of study up to 3 years | 
| Percentage of Participants with Adverse Events of Special Interest |  | From date of metastatic colorectal cancer diagnosis to end of study up to 3 years |