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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metastatic Colorectal Cancer Participants | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bevacizumab | Drug | Administration of treatment will be as used in normal daily routine under local labeling. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Participants with metastatic colorectal cancer
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| 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 |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |