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This prospective observational study will evaluate the safety and efficacy of Xeloda (capecitabine) administered in monotherapy in patients with metastatic colorectal cancer. Patients will be followed until disease progression or unacceptable toxicity occurs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Number of participants with non-serious AEs was exclusive of serious AEs. | Baseline up to end of study (up to 42 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Disease Progression | Disease progression was defined as greater than 20 percent (%) increase in sum of longest diameter of target lesions compared to baseline. | Baseline to progressive disease or death (up to 42 months) |
| Progression-Free Survival (PFS) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with metastatic colorectal cancer
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Belgrade | 11000 | Serbia | ||||
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| ID | Title | Description |
|---|---|---|
| FG000 | mCRC Participants | Participants who were receiving capecitabine (Xeloda) as per local label for the treatment of metastatic colorectal cancer (mCRC) were followed until progression of the disease (PD), unacceptable toxicity, lost to follow up, death from any cause, or withdrawal of informed consent. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Baseline population included all enrolled participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | mCRC Participants | Participants who were receiving capecitabine (Xeloda) as per local label for the treatment of mCRC were followed until PD, unacceptable toxicity, lost to follow up, death from any cause, or withdrawal of informed consent. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Number of participants with non-serious AEs was exclusive of serious AEs. | Intent-to-treat (ITT) population included all participants who received at least one dose of the study drug and had a subsequent post baseline assessment. | Posted | Number | Participants | Baseline up to end of study (up to 42 months) |
|
Baseline up to end of study (up to 42 months)
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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 | mCRC Participants | Participants who were receiving capecitabine (Xeloda) as per local label for the treatment of mCRC were followed until PD, unacceptable toxicity, lost to follow up, death from any cause, or withdrawal of informed consent. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-LaRoche | 800-821-8590 | genentech@druginfo.com |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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PFS was defined as the period from study entry until disease progression or death from any cause. Disease progression was defined as greater than 20% increase in sum of longest diameter of target lesions compared to baseline. |
| Baseline to progressive disease or death (up to 42 months) |
| Number of Participants With Hand-Foot Syndrome (HFS) | HFS, also called palmar-plantar erythrodysesthesia, is a side effect or toxicity associated with specific chemotherapy treatments. The National Cancer Institute (2010) describes it as a condition marked by pain, swelling, numbness, tingling, or redness of the hands or feet. | Baseline up to end of study (up to 42 months) |
| Belgrade |
| 11080 |
| Serbia |
| Kamenitz | 21204 | Serbia |
| Kragujevac | 34000 | Serbia |
| Niš | 18000 | Serbia |
| Withdrawal by Subject |
|
| Investigator Decision |
|
| Death |
|
| Other |
|
| Missing |
|
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | Percentage of Participants With Disease Progression | Disease progression was defined as greater than 20 percent (%) increase in sum of longest diameter of target lesions compared to baseline. | ITT population. Here, number of participants analyzed (N) signifies those participants who were evaluable for this outcome. | Posted | Number | Percentage of participants | Baseline to progressive disease or death (up to 42 months) |
|
|
|
| Secondary | Progression-Free Survival (PFS) | PFS was defined as the period from study entry until disease progression or death from any cause. Disease progression was defined as greater than 20% increase in sum of longest diameter of target lesions compared to baseline. | ITT population. Here, number of participants analyzed (N) signifies those participants who were evaluable for this outcome. | Posted | Median | 95% Confidence Interval | Months | Baseline to progressive disease or death (up to 42 months) |
|
|
|
| Secondary | Number of Participants With Hand-Foot Syndrome (HFS) | HFS, also called palmar-plantar erythrodysesthesia, is a side effect or toxicity associated with specific chemotherapy treatments. The National Cancer Institute (2010) describes it as a condition marked by pain, swelling, numbness, tingling, or redness of the hands or feet. | ITT population. | Posted | Number | Participants | Baseline up to end of study (up to 42 months) |
|
|
|
| 11 |
| 258 |
| 132 |
| 258 |
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Non-systematic Assessment |
|
| Cardiotoxicity | Cardiac disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Thrombophlebitis | Vascular disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Chest pain | General disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (18.0) | 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.
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |