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An Observational Study of Xeloda (Capecitabine) in Patients With Metastatic Colorectal Cancer (AXIOM)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01697462
First Posted: October 2, 2012
Last Update Posted: January 26, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hoffmann-La Roche
  Purpose
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.

Condition
Colorectal Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Safety and Efficacy of Xeloda in Metastatic Colorectal Carcinoma

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • 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) ]
    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.


Secondary Outcome Measures:
  • Percentage of Participants With Disease Progression [ Time Frame: Baseline to progressive disease or death (up to 42 months) ]
    Disease progression was defined as greater than 20 percent (%) increase in sum of longest diameter of target lesions compared to baseline.

  • Progression-Free Survival (PFS) [ Time Frame: Baseline to progressive disease or death (up to 42 months) ]
    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.

  • Number of Participants With Hand-Foot Syndrome (HFS) [ Time Frame: Baseline up to end of study (up to 42 months) ]
    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.


Enrollment: 258
Study Start Date: July 2009
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with metastatic colorectal cancer
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01697462


Locations
Serbia
Belgrade, Serbia, 11000
Belgrade, Serbia, 11080
Kragujevac, Serbia, 34000
NIS, Serbia, 18000
Sremska Kamenica, Serbia, 21204
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01697462     History of Changes
Other Study ID Numbers: ML22585
First Submitted: September 28, 2012
First Posted: October 2, 2012
Results First Submitted: December 16, 2015
Results First Posted: January 26, 2016
Last Update Posted: January 26, 2016
Last Verified: November 2015

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases