An Observational Study of Xeloda (Capecitabine) Monotherapy in Patients With Colorectal Cancer (AXEL)

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01276405
First received: January 12, 2011
Last updated: July 1, 2016
Last verified: July 2016

January 12, 2011
July 1, 2016
March 2010
October 2015   (final data collection date for primary outcome measure)
Disease-free survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01276405 on ClinicalTrials.gov Archive Site
Safety (Incidence of adverse events) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
An Observational Study of Xeloda (Capecitabine) Monotherapy in Patients With Colorectal Cancer (AXEL)
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)
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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample
Patients with colon cancer stage III (Duke C) on Xeloda monotherapy
Colorectal Cancer
Not Provided
Cohort
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
123
October 2015
October 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult patients, over the age of 18 years
  • Presence of colon adenocarcinoma
  • Surgical resection for colon cancer stage III (Duke C)
  • Prior adjuvant therapy with Xeloda monotherapy

Exclusion Criteria:

  • Contraindications for Xeloda
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Romania
 
NCT01276405
ML25174
Not Provided
Not Provided
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP