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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT01697462 |
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Date of registration:
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28/09/2012 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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An Observational Study of Xeloda (Capecitabine) in Patients With Metastatic Colorectal Cancer (AXIOM)
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Scientific title:
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Evaluation of Safety and Efficacy of Xeloda in Metastatic Colorectal Carcinoma |
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Date of first enrolment:
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July 2009 |
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Target sample size:
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258 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01697462 |
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Study type:
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Observational |
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Study design:
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Phase:
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N/A
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Countries of recruitment
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Serbia
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Contacts
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Name:
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Clinical Trials |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hoffmann-La Roche |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Adult patients, >/= 18 years of age
- Metastatic colorectal cancer
- Receiving Xeloda according to registered indication
Exclusion Criteria:
- Patients who are not eligible for Xeloda treatment according to the Summary of Product
Characteristics
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Colorectal Cancer
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Primary Outcome(s)
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Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs)
[Time Frame: Baseline up to end of study (up to 42 months)]
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Secondary Outcome(s)
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Percentage of Participants With Disease Progression
[Time Frame: Baseline to progressive disease or death (up to 42 months)]
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Number of Participants With Hand-Foot Syndrome (HFS)
[Time Frame: Baseline up to end of study (up to 42 months)]
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Progression-Free Survival (PFS)
[Time Frame: Baseline to progressive disease or death (up to 42 months)]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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