An Observational Study of Xeloda (Capecitabine) in Patients With Metastatic Colorectal Cancer (AXIOM)
|ClinicalTrials.gov Identifier: NCT01697462|
Recruitment Status : Completed
First Posted : October 2, 2012
Results First Posted : January 26, 2016
Last Update Posted : January 26, 2016
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||258 participants|
|Official Title:||Evaluation of Safety and Efficacy of Xeloda in Metastatic Colorectal Carcinoma|
|Study Start Date :||July 2009|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||December 2012|
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01697462
|Belgrade, Serbia, 11000|
|Belgrade, Serbia, 11080|
|Kragujevac, Serbia, 34000|
|NIS, Serbia, 18000|
|Sremska Kamenica, Serbia, 21204|
|Study Director:||Clinical Trials||Hoffmann-La Roche|