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.
Study Type
OBSERVATIONAL
Enrollment
258
Unnamed facility
Belgrade, Serbia
Unnamed facility
Belgrade, Serbia
Unnamed facility
Kamenitz, Serbia
Unnamed facility
Kragujevac, Serbia
Unnamed facility
Niš, Serbia
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.
Time frame: Baseline up to end of study (up to 42 months)
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.
Time frame: Baseline to progressive disease or death (up to 42 months)
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.
Time frame: Baseline to progressive disease or death (up to 42 months)
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.
Time frame: Baseline up to end of study (up to 42 months)
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