An Observational Study of Xeloda (Capecitabine) Monotherapy in Patients With Colorectal Cancer (AXEL)
This study is ongoing, but not recruiting participants.
Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01276405
First received: January 12, 2011
Last updated: May 23, 2013
Last verified: May 2013
| Tracking Information | |||||
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| First Received Date ICMJE | January 12, 2011 | ||||
| Last Updated Date | May 23, 2013 | ||||
| Start Date ICMJE | March 2010 | ||||
| Estimated Primary Completion Date | October 2014 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Disease-free survival [ Time Frame: 3 years ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01276405 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Safety (Incidence of adverse events) [ Time Frame: 3 years ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | An Observational Study of Xeloda (Capecitabine) Monotherapy in Patients With Colorectal Cancer (AXEL) | ||||
| Official Title ICMJE | The Efficacy of Adjuvant Chemotherapy With Capecitabine (Xeloda) Monotherapy in Patients With Colon Cancer Stage III (Duke C) Considering the Histopathology of the Tumour (AXEL) | ||||
| Brief Summary | This observational study will evaluate Xeloda (capecitabine) monotherapy on the effect of disease-free survival in patients with colon cancer stage III (Duke C) after surgical resection. Data will be collected for 3 years. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | Patients with colon cancer stage III (Duke C) on Xeloda monotherapy |
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| Condition ICMJE | Colorectal Cancer | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Cohort | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Enrollment ICMJE | 100 | ||||
| Estimated Completion Date | October 2014 | ||||
| Estimated Primary Completion Date | October 2014 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Romania | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01276405 | ||||
| Other Study ID Numbers ICMJE | ML25174 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Hoffmann-La Roche | ||||
| Study Sponsor ICMJE | Hoffmann-La Roche | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Hoffmann-La Roche | ||||
| Verification Date | May 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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