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This single arm study will evaluate the safety profile of Xeloda as monotherapy for adjuvant treatment of colon cancer. All patients will receive Xeloda 1250mg/m2 p.o. twice daily as intermittent treatment (3 week cycles consisting of 2 weeks of treatment followed by 1 week without treatment). The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| capecitabine [Xeloda] | Drug | 1250mg/m2 po bid on days 1-14 of each 3 week cycle |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With an Adverse Event (AE), Serious AE, or Death Due to an AE | The postmarketing safety profile of capecitabine was evaluated by collection of AEs, clinical laboratory data, vital signs, and other findings from physical examination. Abnormalities in these findings were captured as AEs, defined as any untoward medical occurrence in a study participant regardless of the suspected cause. Serious AEs were those which, at any dose, met one or more of the following criteria: resulted in fatality, were life-threatening, necessitated new or prolonged existing hospitalization, produced persistent or significant disability, resulted in congenital anomaly or birth defect, were considered medically significant, or required intervention to prevent any of the aforementioned outcomes. Those specific serious AEs which resulted in fatality were also reported separately. The percentage of participants with an AE, serious AE, or AE resulting in death was calculated as [number of participants with event divided by number analyzed] multiplied by 100. | Up to 25 weeks (from Baseline to the end of safety follow-up) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Early Withdrawal or Discontinuation Due to an AE | The postmarketing safety profile of capecitabine was evaluated by collection of AEs, clinical laboratory data, vital signs, and other findings from physical examination. Abnormalities in these findings were captured as AEs, defined as any untoward medical occurrence in a study participant regardless of the suspected cause. The percentage of participants with early withdrawal or treatment discontinuation due to an AE was calculated as [number of participants with event divided by number analyzed] multiplied by 100. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arkhangelsk | 163045 | Russia | ||||
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| ID | Title | Description |
|---|---|---|
| FG000 | Capecitabine | Participants with resected Stage III colon cancer (Dukes C) or high-risk Stage II colon cancer (Dukes B) received capecitabine orally (PO) as 1250 milligrams per meter-squared (mg/m^2) twice daily, once in the morning and once at night, in this non-randomized postmarketing safety study. For those with moderate renal insufficiency at Baseline, the initial dose was reduced to 950 mg/m^2 twice daily. Each 3-week cycle comprised 2 weeks of continuous treatment followed by a 1-week break, and treatment continued for up to 8 cycles (24 weeks) or until relapse, new-onset colon cancer, or unacceptable toxicity. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Up to 25 weeks (from Baseline to the end of safety follow-up) |
| Astrakhan |
| 414041 |
| Russia |
| Barnaul | 656049 | Russia |
| Belgorod | 308010 | Russia |
| Chelyabinsk | 454047 | Russia |
| Irkutsk | 664035 | Russia |
| Izhevsk | 426009 | Russia |
| Kaluga | 248007 | Russia |
| Kazan' | 420029 | Russia |
| Kazan' | 420111 | Russia |
| Kirov | 610021 | Russia |
| Kostroma | 156005 | Russia |
| Krasnodar | 350040 | Russia |
| Kursk | 305035 | Russia |
| Lipetsk | 398005 | Russia |
| Moscow | 105229 | Russia |
| Moscow | 107005 | Russia |
| Moscow | 119992 | Russia |
| Moscow | 123354 | Russia |
| Moscow | 127006 | Russia |
| Moscow | 143420 | Russia |
| Nizhny Novgorod | 603126 | Russia |
| Novgorod Veliky | 173016 | Russia |
| Obninsk | 249036 | Russia |
| Orenburg | 460021 | Russia |
| Perm | 614 066 | Russia |
| Rostov-on-Don | 344037 | Russia |
| Ryazan | 390011 | Russia |
| Saint Petersburg | 197022 | Russia |
| Saint Petersburg | 197047 | Russia |
| Salekhard | 629001 | Russia |
| Samara | 443031 | Russia |
| Sashi | 354057 | Russia |
| Smolensk | 214000 | Russia |
| Stavropol | 355047 | Russia |
| Surgut | 628408 | Russia |
| Tollyatti | 445846 | Russia |
| Tomsk | 634028 | Russia |
| Tomsk | 634050 | Russia |
| Tver' | 170008 | Russia |
| Tyumen | 625047 | Russia |
| Ufa | 450005 | Russia |
| Ufa | 450054 | Russia |
| Volgograd | 400138 | Russia |
| Yekaterinburg | 620905 | Russia |
| Yuzhno-Sakhalinsk | 693010 | Russia |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety Population: All enrolled participants who received a dose of study medication.
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| ID | Title | Description |
|---|---|---|
| BG000 | Capecitabine | Participants with resected Stage III colon cancer (Dukes C) or high-risk Stage II colon cancer (Dukes B) received capecitabine PO as 1250 mg/m^2 twice daily, once in the morning and once at night, in this non-randomized postmarketing safety study. For those with moderate renal insufficiency at Baseline, the initial dose was reduced to 950 mg/m^2 twice daily. Each 3-week cycle comprised 2 weeks of continuous treatment followed by a 1-week break, and treatment continued for up to 8 cycles (24 weeks) or until relapse, new-onset colon cancer, or unacceptable toxicity. |
| 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 | Percentage of Participants With an Adverse Event (AE), Serious AE, or Death Due to an AE | The postmarketing safety profile of capecitabine was evaluated by collection of AEs, clinical laboratory data, vital signs, and other findings from physical examination. Abnormalities in these findings were captured as AEs, defined as any untoward medical occurrence in a study participant regardless of the suspected cause. Serious AEs were those which, at any dose, met one or more of the following criteria: resulted in fatality, were life-threatening, necessitated new or prolonged existing hospitalization, produced persistent or significant disability, resulted in congenital anomaly or birth defect, were considered medically significant, or required intervention to prevent any of the aforementioned outcomes. Those specific serious AEs which resulted in fatality were also reported separately. The percentage of participants with an AE, serious AE, or AE resulting in death was calculated as [number of participants with event divided by number analyzed] multiplied by 100. | Safety Population. | Posted | Number | percentage of participants | Up to 25 weeks (from Baseline to the end of safety follow-up) |
|
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Early Withdrawal or Discontinuation Due to an AE | The postmarketing safety profile of capecitabine was evaluated by collection of AEs, clinical laboratory data, vital signs, and other findings from physical examination. Abnormalities in these findings were captured as AEs, defined as any untoward medical occurrence in a study participant regardless of the suspected cause. The percentage of participants with early withdrawal or treatment discontinuation due to an AE was calculated as [number of participants with event divided by number analyzed] multiplied by 100. | Safety Population. | Posted | Number | percentage of participants | Up to 25 weeks (from Baseline to the end of safety follow-up) |
|
|
Up to 25 weeks (from Baseline to the end of safety follow-up)
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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 with resected Stage III colon cancer (Dukes C) or high-risk Stage II colon cancer (Dukes B) received capecitabine PO as 1250 mg/m^2 twice daily, once in the morning and once at night, in this non-randomized postmarketing safety study. For those with moderate renal insufficiency at Baseline, the initial dose was reduced to 950 mg/m^2 twice daily. Each 3-week cycle comprised 2 weeks of continuous treatment followed by a 1-week break, and treatment continued for up to 8 cycles (24 weeks) or until relapse, new-onset colon cancer, or unacceptable toxicity. | 14 | 228 | 81 | 228 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial infarction | Cardiac disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Abdominal abscess | Gastrointestinal disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Colon cancer | Gastrointestinal disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Death | General disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Disease progression | General disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Metastasis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.0) | Non-systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Nervous system disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Hospitalisation | Surgical and medical procedures | MedDRA (15.0) | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA (15.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hyperbilirubinaemia | Blood and lymphatic system disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Nervous system disorders | MedDRA (15.0) | Non-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-LaRoche | 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 |
| 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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