A Phase III Trial to Evaluate the Efficacy and Safety of the Combination Therapy of Capecitabine and Oxaliplatin (XELOX) in Comparison to the Combination Therapy of Fluorouracil/Folinic Acid and Oxaliplatin (FOLFOX) in Patients With AGC
Quality assurance: Data will be collected, controlled, and monitored at the Korean Clinical
Study Group (KCSG) data center.
Data will be entered throuGh the E-Case report form (CRF) (Web based data input)
Korean Clinical Study Group (KCSG) data center will do the standard Operating Procedures to
address registry operations and analysis activities, such as patient recruitment, data
collection, data management, data analysis, reporting for adverse events, and change
management
Sample size assessment to specify the number of participants or participant years was
consulted Statistical specialist. And data analysis will be also discuss with him
Expected median progression-free survival(PFS) in Xelox: 6 months total number of events
required: 359 197 patients will be needed After 10% of follow-up loss, 219 patients in each
arm, a total of 438 patients will be enrolled
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression free survival
6 months after treatment
No
Sung Yong Oh, M.D.
Principal Investigator
Dong-A University Hospital
Korea: Food and Drug Administration
KCSG ST12-05
NCT01748851
December 2012
December 2018
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