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This multicenter observational study will evaluate the efficacy and safety of first-line bevacizumab (Avastin) in combination with fluoropyrimidine-based chemotherapy in participants with metastatic colorectal cancer (mCRC). Participants for whom the treating physician has decided to initiate first-line fluoropyrimidine based chemotherapy in combination with bevacizumab will be observed for approximately 4 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mCRC Participants | mCRC participant will receive bevacizumab as per approved label with the approved first-line fluoropyrimidine based chemotherapy, as per physician discretion. The protocol does not specify the chemotherapy regimen to be used, the choice of chemotherapy will be at the discretion of treating physician. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bevacizumab | Drug | Bevacizumab will be administered as per approved label. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival from the time of starting first-line therapy | Start of first line therapy until death (up to approximately 4 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival from the time of starting first-line therapy, assessed according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) criteria | Start of first line therapy until death (up to approximately 4 years) | |
| Percentage of participants with best overall response, assessed according to RECIST v.1.1 criteria |
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Inclusion Criteria:
Exclusion Criteria:
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Participants with metastatic colorectal cancer receiving first-line bevacizumab in combination with fluoropyrimidine-based chemotherapy
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chang Gung Medical Foundation - Chai Yi; Surgery | CHAI YI | 613 | Taiwan | |||
| Kaohsiung Chang Gung Memorial Hospital; Colorectal Surgery |
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| Chemotherapy | Drug | The protocol does not specify the chemotherapy regimen to be used, the choice of chemotherapy will be at the discretion of treating physician. |
|
| Start of first line therapy until death (up to approximately 4 years) |
| Percentage of participants with liver resection | up to approximately 4 years |
| Number of participants with adverse events | up to approximately 4 years |
| Kaohsiung City |
| 00833 |
| Taiwan |
| Kaohsiung Medical Uni Chung-Ho Hospital; Dept of Surgery | Kaohsiung City | 807 | Taiwan |
| Taichung Veterans General Hospital; Dept of Surgery | Taichung | 407 | Taiwan |
| National Cheng Kung Uni Hospital; Dept of Hematology and Oncology | Tainan | 704 | Taiwan |
| Veterans General Hospital; Division of Oncology | Taipei | 00112 | Taiwan |
| Tri-Service General Hospital; Hematology and Oncology | Taipei | 114 | Taiwan |
| Mackay Memorial Hospital; Department of Surgery, Division of Colon and Rectal Surgery | Taipei | Taiwan |
| Chang Gung Medical Foundation - Linkou; Colo-rectal Surgery | Taoyuan | 333 | Taiwan |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D013812 | Therapeutics |
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