An Observational Study of Avastin in Participants With Metastatic Colorectal Cancer (KORALLE)

Study Overview
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Brief Summary
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This observational multicenter study will evaluate the differences in progression-free survival defined in specific subgroups of participants with metastatic colorectal cancer receiving bevacizumab (Avastin). Further, safety and efficacy in daily routine will be assessed.

Official Title
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Avastin ® First Line and Where Applicable Beyond First Progression With Metastatic Colorectal Carcinoma

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Drug: Bevacizumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants with metastatic colorectal cancer where physician has decided to give a first-line, fluoro-pyrimidine-based combination therapy with bevacizumab according to Summary of Product Characteristics (SmPC) Exclusion Criteria: Contraindications for bevacizumab according to SmPC

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 |
| --- | --- |
| Metastatic Colorectal Cancer Participants<br>Administration of treatment will be as used in normal daily routine under local labelling in 4 subgroups- participants with liver and/or lung metastases, potentially resectable after a response to a systemic therapy and clinically operable; participants with tumor related symptoms, risks for complications or fast progression for whom quick proliferation control is needed; asymptomatic participants (indolent tumor) without the option of a metastases resection (no pressure for remission) for whom the aim of the therapy is proliferation control and participants without classification. | Drug: Bevacizumab<br>* Administration of treatment will be as used in normal daily routine under local labeling.<br>* Other names: Avastin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median Progression-Free Survival Time in Defined Participant Subgroups as Assessed by Response Evaluation Criteria In Solid Tumors (RECIST) |  | Baseline up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants by Prognostic Factors |  | Baseline up to 5 years | 
| Percentage of Participants by Carcinoembryonic Antigen Tumor Marker |  | Baseline | 
| Percentage of Participants by Cancer Antigen 19-9 Tumor Marker |  | Baseline | 
| Percentage of Participants by Eastern Cooperative Oncology Group (ECOG) Performance Status |  | Baseline | 
| Percentage of Participants by Comorbidity Index as per Carlson Method |  | Baseline | 
| Percentage of Participants by RAS Mutation Status |  | Baseline | 
| Percentage of Participants by Cancer Metastasation Status |  | Baseline | 
| Percentage of Participants According to Previous Treatment Regimen of Bevacizumab |  | Baseline | 
| Progression-Free Survival as Assessed by RECIST (Overall) |  | Baseline up to 5 years | 
| Overall Survival in Daily Routine Practice |  | Baseline up to 5 years | 
| Overall Survival in Defined Participant Subgroups in Daily Routine Practice |  | Baseline up to 5 years | 
| Percentage of Participants Showing Overall Response in Daily Routine Practice as Assessed by RECIST |  | Baseline up to 5 years | 
| Number of Treatment Application Schemes of Bevacizumab Daily Routine Practice |  | Baseline up to 5 years | 
| Number of Participants With Adverse Event |  | Baseline up to 5 years | 
| Number of Participants With Reason for Bevacizumab Treatment Modifications and Discontinuation in Defined Participant Subgroups |  | Baseline up to 5 years | 
| Total Cumulative Therapy Dose of Bevacizumab |  | Baseline up to 5 years | 
| Percentage of Participants With Treatment Success |  | Baseline up to 5 years | 
| Percentage of Participants With Resection |  | Baseline up to 5 years | 
| Number of Physicians Satisfied With Treatment |  | Baseline up to 5 years | 
| Percentage of Participants Without Resection by Reason |  | Baseline up to 5 years | 
| Percentage of Participants With Follow-Up therapy |  | Baseline up to 5 years | 
| Percentage of Participants in Defined Participant Subgroups Showing Overall Response in Daily Routine Practice as Assessed by RECIST |  | Baseline up to 5 years |