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This observational study evaluates the efficacy and safety of capecitabine in combination with oxaliplatin in the adjuvant setting in participants with Stage III colon cancer. Data were collected from each participant for up to 36 months or until disease recurrence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Capecitabine + Oxaliplatin | Participants with stage lll colon cancer, who were starting adjuvant chemotherapy with capecitabine in combination with oxaliplatin according to standard of care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Capecitabine | Drug | Administered according to the Summary of Product Characteristics. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Disease-Free Survival (Time to Event) | Disease free survival was measured as the time from the date of randomization until the date of first event (recurrence of colon cancer, or death due to any cause). | Up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Percentage of Participants With Adverse Events | An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. |
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Inclusion Criteria:
Exclusion Criteria:
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Participants with Stage III colon cancer
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banská Bystrica | 975 17 | Slovakia | ||||
Two participants were screening failures. 74 participants were assigned to the study and treated with study drug.
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| ID | Title | Description |
|---|---|---|
| FG000 | Capecitabine + Oxaliplatin | Participants with stage lll colon cancer, who were starting adjuvant chemotherapy with capecitabine in combination with oxaliplatin according to standard of care. Capecitabine: Administered according to the Summary of Product Characteristics. Oxaliplatin: Administered according to the Summary of Product Characteristics. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Oxaliplatin | Biological | Administered according to the Summary of Product Characteristics. |
|
| Up to 3 years |
| Bratislava |
| 812 50 |
| Slovakia |
| Bratislava | 833 10 | Slovakia |
| Košice | 04001 | Slovakia |
| Martin | 036 59 | Slovakia |
| Nitra | 950 01 | Slovakia |
| Poprad | 058 01 | Slovakia |
| Prešov | 081 81 | Slovakia |
| Ružomberok | 03426 | Slovakia |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Capecitabine + Oxaliplatin | Participants with stage lll colon cancer, who were starting adjuvant chemotherapy with capecitabine in combination with oxaliplatin according to standard of care. Capecitabine: Administered according to the Summary of Product Characteristics. Oxaliplatin: Administered according to the Summary of Product Characteristics. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 | Disease-Free Survival (Time to Event) | Disease free survival was measured as the time from the date of randomization until the date of first event (recurrence of colon cancer, or death due to any cause). | Intent-to-treat (ITT) population included all participants treated with at least one dose of study drug. Here, number of participants analyzed is number evaluable for efficacy. | Posted | Median | 95% Confidence Interval | months | Up to 3 years |
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| Secondary | Safety: Percentage of Participants With Adverse Events | An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. | Safety population included all participants treated with at least one dose of study drug. | Posted | Number | percentage of participants | Up to 3 years |
|
|
Up to 3 years
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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 + Oxaliplatin | Participants with stage lll colon cancer, who were starting adjuvant chemotherapy with capecitabine in combination with oxaliplatin according to standard of care. Capecitabine: Administered according to the Summary of Product Characteristics. Oxaliplatin: Administered according to the Summary of Product Characteristics. | 1 | 74 | 23 | 74 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Paresthesia | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
|
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 | 800 821-8590 | genentech@druginfo.com |
| 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 |
|---|---|
| D000069287 | Capecitabine |
| D000077150 | Oxaliplatin |
| 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 |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
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