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

Completed

• Conditions: Colorectal Cancer

• Registration Number: NCT01697462
• Lead Sponsor: Hoffmann-La Roche

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2012-09-28
• Study First Submitted QC: 2012-09-28
• Study First Posted: 2012-10-02
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2015-11
• Results First Submitted: 2015-12-16
• Results First Submitted QC: 2015-12-16
• Last Update Submitted: 2015-12-16
• Results First Posted: 2016-01-26
• Last Update Posted: 2016-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 258

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs)	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

Name	Time	Method
Percentage of Participants With Disease Progression	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.
Number of Participants With Hand-Foot Syndrome (HFS)	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.
Progression-Free Survival (PFS)	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.