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This prospective, multicenter, observational study will investigate the effectiveness and safety of bevacizumab in routine clinical practice in participants with metastatic CRC. Participants are to have initiated first-line treatment with fluoropyrimidine-based doublet chemotherapy plus bevacizumab according to the bevacizumab Summary of Product Characteristics (SmPC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with CRC | This is an observational study; thus, no intervention or treatment is required by the protocol. During the study, the treatment will be determined according to the treating physician decision. Eligible participants will be observed for safety and efficacy of continued bevacizumab plus fluoropyrimidine-based doublet chemotherapy treatment in routine clinical practice for 1 year. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bevacizumab | Other | Bevacizumab at a dose and schedule according to approved label and SmPC. The recommended dose of bevacizumab, administered as an intravenous infusion, is either 5 milligrams per kilogram (mg/kg) or 10 mg/kg of body weight given once every 2 weeks or 7.5 mg/kg or 15 mg/kg of body weight given once every 3 weeks. Bevacizumab is always used in combination with chemotherapy for the treatment of participants with metastatic CRC. It is recommended that treatment be continued until progression of the underlying disease or until unacceptable toxicity. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) | From enrollment to the first documented progression or death from any cause, whichever occurs first (maximum up to 36 months) |
| Measure | Description | Time Frame |
|---|---|---|
| PFS on First-Line Therapy | From first dose of bevacizumab first-line treatment up to the first documented progression or death from any cause, whichever occurs first (maximum up to 36 months) | |
| Percentage of Participants who were Alive at 1 Year | From enrollment up to death from any cause, maximum up to 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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Adult participants with metastatic CRC in first-line setting in Hungary
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Szent Margit Hospital | Budapest | 1032 | Hungary | |||
| Semmelweis Egyetem Onkologiai Központ |
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| Chemotherapy | Combination Product | Fluoropyrimidine-based doublet chemotherapy (5-Fluorouracil [5-FU] or capecitabine plus oxaliplatin or irinotecan) as first-line treatment; and continued fluoropyrimidine treatment with or without treatment modification for oxaliplatin or irinotecan, as per treating physician discretion. |
|
| Duration of Bevacizumab Plus Chemotherapy Treatment | From Baseline up to 36 months |
| Percentage of Participants with Best Overall Response Assessed by Treating Physicians Using Response Evaluation Criteria in Solid Tumors (RECIST) | From Baseline up to 36 months |
| Percentage of Participants with Reason for Bevacizumab Plus Chemotherapy Treatment Discontinuation | From enrollment to the treatment discontinuation (maximum up to 36 months) |
| Percentage of Participants with Protocol Defined Baseline Participant and Disease Characteristics | Protocol defined baseline participant and disease characteristics include: gender (male, female); age at enrollment (less than [<] 65 years, greater than or equal to [>/=] 65 years); Eastern Cooperative Oncology Group (ECOG) performance status (0,1, >/=2); primary tumor location (colon, rectum); liver metastasis only (yes, no); number and sites of organs with metastases (less than or equal to [</=] 1, greater than [>] 1); prior adjuvant chemotherapy (yes, no); resection of primary tumor (yes, no); disease stage at the time of diagnosis; disease-free interval between CRC disease diagnosis and diagnosis of metastatic stage; and mutation status (RAS, BRAF) if available. | Baseline |
| Percentage of Participants with Adverse Events (AEs) and Serious AEs | From Baseline up to 36 months |
| Budapest |
| 1083 |
| Hungary |
| Szent Imre Hospital | Budapest | 1115 | Hungary |
| Orszagos Onkologiai Intezet; B Belgyogyaszati Osztaly | Budapest | 1122 | Hungary |
| Semmelweis Egyetem Aok; Iii.Sz. Belgyogyaszati Klinika | Budapest | 1125 | Hungary |
| Fövárosi Önkormányzat uzsoki utcai Kórház | Budapest | 1145 | Hungary |
| Kenezy Korhaz Rendelointezet | Debrecen | 4031 | Hungary |
| Debreceni Egyetem Klinikai Kozpont ; Department of Oncology | Debrecen | 4032 | Hungary |
| Petz Aladar Megyei Oktato Korhaz | Győr | 9024 | Hungary |
| Békés Megyei Pándy Kálmán Kórház; Onkologiai tanszek | Gyula | 5703 | Hungary |
| Kaposi Mor Teaching Hospital | Kaposvár | 7400 | Hungary |
| Bacs-Kiskun Megyei Korhaz, SZTE AOK Oktato Korhaza, Onkoradiologiai Kozpont | Kecskemét | 6000 | Hungary |
| Borsod-Abauj-Zemplen Megyei Korhaz Es Egyetemi Oktato Korhaz; Onkologiai Osztaly | Miskolc | 3501 | Hungary |
| Josa Andras Korhaz; Dept of Oncoradiology | Nyíregyháza | 4400 | Hungary |
| Pécsi Tudományegyetem Áok; Onkoterapias Intezet | Pécs | 7624 | Hungary |
| Szegedi Tudomanyegyetem, AOK, Szent-Gyorgyi Albert Klinikai Kozpont, Onkoterapias Klinika | Szeged | 6720 | Hungary |
| Tolna Megyei Onkormanyzat Balassa Janos Korhaz | Szekszárd | 7100 | Hungary |
| Szent Gyorgy Korhaz;Fejer Megyei | Székesfehérvár | 8000 | Hungary |
| Markusovszky Hospital | Szombathely | 9700 | Hungary |
| Szent Borbala Korhaz | Tatabánya | 2800 | Hungary |
| Veszprem Megyei Csolnoky; Ferenc Korhaz | Veszprém | 8200 | Hungary |
| Zala megyei Önkormányzat Kórház és Rendelõintézet | Zalaegerszeg | 8900 | Hungary |
| 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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