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

Colorectal Cancer Clinical Trial

Official title:

Evaluation of Safety and Efficacy of Xeloda in Metastatic Colorectal Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01697462
• Other study ID #: ML22585
• Status: Completed
• Phase: N/A
• First received: September 28, 2012
• Last updated: December 16, 2015
• Start date: July 2009
• Est. completion date: December 2012

Study information

• Verified date: November 2015
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Serbia: Medicines and Medical Devices Agency
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 258
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Serbia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	Percentage of Participants With Disease Progression	Disease progression was defined as greater than 20 percent (%) increase in sum of longest diameter of target lesions compared to baseline.	Baseline to progressive disease or death (up to 42 months)	No
Secondary	Progression-Free Survival (PFS)	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.	Baseline to progressive disease or death (up to 42 months)	No
Secondary	Number of Participants With Hand-Foot Syndrome (HFS)	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.	Baseline up to end of study (up to 42 months)	No