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This multi-center observational study will evaluate the use of Xeloda (capecitabine) in patients with metastatic colorectal cancer, colon cancer in the adjuvant setting, advanced gastric cancer and breast cancer in routine clinical practice. Eligible patients receiving treatment with Xeloda according to product label will be followed for up to 10 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Capecitabine | Participants will receive capecitabine according to the label text as monotherapy (1250 mg/m^2 twice daily) or combination therapy (800 to 1000 mg/m^2 or 1250 mg/m^2 twice daily) for 14 consecutive days followed by a treatment break of 7 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Capecitabine | Drug | Capecitabine will be given according to the label text as monotherapy (1250 mg/m^2 twice daily) or combination therapy (800 to 1000 mg/m^2 or 1250 mg/m^2 twice daily) for 14 consecutive days followed by a treatment break of 7 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Routine Clinical Use of Capecitabine as Per the Line of Treatment | Choice of line of treatment in adjuvant and advanced or metastatic cancer for capecitabine was observed. | Approximately 3 years; or up to disease progression, death or stop of capecitabine treatment, whichever occurred first |
| Measure | Description | Time Frame |
|---|---|---|
| Median Dose of Capecitabine | Median dose of capecitabine for treatment of metastatic colorectal cancer, adjuvant colon cancer, advanced gastric cancer, or metastatic breast cancer in this study was presented. | Approximately 3 years; or up to disease progression, death or stop of capecitabine treatment, whichever occurred first |
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Inclusion Criteria:
Exclusion Criteria:
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Patients metastatic colorectal cancer, colon cancer in the adjuvant setting, advanced gastric cancer or breast cancer receiving Xeloda
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vienna | 1090 | Austria |
Of 563 participants, 220 were treated for adjuvant colon cancer, 200 were treated for metastatic colorectal cancer, 84 were treated for metastatic breast cancer, and 59 were treated for advanced gastric cancer.
A total of 563 participants were included from April 2010 to July 2012 at 21 sites in Austria.
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| ID | Title | Description |
|---|---|---|
| FG000 | Capecitabine | Participants received capecitabine according to the label text as monotherapy (1250 mg/m^2 twice daily) or combination therapy (800 to 1000 mg/m^2 or 1250 mg/m^2 twice daily) for 14 consecutive days followed by a treatment break of 7 days. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Capecitabine | Participants received capecitabine according to the label text as monotherapy (1250 mg/m^2 twice daily) or combination therapy (800 to 1000 mg/m^2 or 1250 mg/m^2 twice daily) for 14 consecutive days followed by a treatment break of 7 days. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Routine Clinical Use of Capecitabine as Per the Line of Treatment | Choice of line of treatment in adjuvant and advanced or metastatic cancer for capecitabine was observed. | All enrolled participants were considered for this outcome measure. | Posted | Number | Participants | Approximately 3 years; or up to disease progression, death or stop of capecitabine treatment, whichever occurred first |
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| Secondary | Median Dose of Capecitabine | Median dose of capecitabine for treatment of metastatic colorectal cancer, adjuvant colon cancer, advanced gastric cancer, or metastatic breast cancer in this study was presented. | All enrolled participants were considered for this outcome measure. | Posted | Median | Full Range | Milligrams | Approximately 3 years; or up to disease progression, death or stop of capecitabine treatment, whichever occurred first |
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Approximately 3 years; or up to disease progression, death or stop of capecitabine treatment, whichever occurred first
SAEs and other AEs were collected in all enrolled participants.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Capecitabine | Participants received capecitabine according to the label text as monotherapy (1250 mg/m^2 twice daily) or combination therapy (800 to 1000 mg/m^2 or 1250 mg/m^2 twice daily) for 14 consecutive days followed by a treatment break of 7 days. | 34 | 563 | 271 | 563 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (18.1) | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA (18.1) | Systematic Assessment |
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| Cardiac arrest | Cardiac disorders | MedDRA (18.1) | Systematic Assessment |
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| Cardiac failure | Cardiac disorders | MedDRA (18.1) | Systematic Assessment |
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| Cardiopulmonary failure | Cardiac disorders | MedDRA (18.1) | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
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| Diverticulum intestinal | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
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| Enteritis | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
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| Enterocolitis haemorrhagic | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
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| Mechanical ileus | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
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| Stomatitis | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
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| Death | General disorders | MedDRA (18.1) | Systematic Assessment |
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| Disease progression | General disorders | MedDRA (18.1) | Systematic Assessment |
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| General physical health deterioration | General disorders | MedDRA (18.1) | Systematic Assessment |
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| Multiple Organ Failure | General disorders | MedDRA (18.1) | Systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
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| Facial bones fracture | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment |
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| Rib fracture | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment |
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| Inflammatory marker increased | Investigations | MedDRA (18.1) | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA (18.1) | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
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| Breast cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.1) | Systematic Assessment |
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| Metastases to bone | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.1) | Systematic Assessment |
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| Metastases to liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.1) | Systematic Assessment |
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| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.1) | Systematic Assessment |
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| Hypertonia | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
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| Acute kidney injury | Renal and urinary disorders | MedDRA (18.1) | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
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| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
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| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Systematic Assessment |
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| Blister | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Systematic Assessment |
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| Skin necrosis | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA (18.1) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palmar-plantar erythrodysesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
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| Stomatitis | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
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The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 1-800-821-8590 | genentech@druginfo.com |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D015179 | Colorectal Neoplasms |
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D013272 | Stomach Diseases |
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| ID | Term |
|---|---|
| D000069287 | Capecitabine |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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| Title | Measurements |
|---|---|
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| Third line therapy |
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