An Observational Study of Xeloda (Capecitabine) in Patients With Metastatic Colorectal Cancer (AXIOM)
Evaluation of Safety and Efficacy of Xeloda in Metastatic Colorectal Carcinoma
1 other identifier
observational
258
1 country
5
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2009
Typical duration for all trials
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2009
CompletedFirst Submitted
Initial submission to the registry
September 28, 2012
CompletedFirst Posted
Study publicly available on registry
October 2, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedResults Posted
Study results publicly available
January 26, 2016
CompletedJanuary 26, 2016
November 1, 2015
3.4 years
September 28, 2012
December 16, 2015
December 16, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
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)
Secondary Outcomes (3)
Percentage of Participants With Disease Progression
Baseline to progressive disease or death (up to 42 months)
Progression-Free Survival (PFS)
Baseline to progressive disease or death (up to 42 months)
Number of Participants With Hand-Foot Syndrome (HFS)
Baseline up to end of study (up to 42 months)
Study Arms (1)
Cohort
Eligibility Criteria
Patients with metastatic colorectal cancer
You may qualify if:
- Adult patients, \>/= 18 years of age
- Metastatic colorectal cancer
- Receiving Xeloda according to registered indication
You may not qualify if:
- Patients who are not eligible for Xeloda treatment according to the Summary of Product Characteristics
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Unknown Facility
Belgrade, 11000, Serbia
Unknown Facility
Belgrade, 11080, Serbia
Unknown Facility
Kamenitz, 21204, Serbia
Unknown Facility
Kragujevac, 34000, Serbia
Unknown Facility
Niš, 18000, Serbia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-LaRoche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 28, 2012
First Posted
October 2, 2012
Study Start
July 1, 2009
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
January 26, 2016
Results First Posted
January 26, 2016
Record last verified: 2015-11