The purpose of this study is to identify the non-inferiority of the combination therapy of Capecitabine and Oxaliplatin compared with the combination therapy of Fluorouracil/Folinic acid and Oxaliplatin in patients with advanced gastric cancer.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
42
Dong-A University Hospital
Busan, South Korea
Progression free survival
Time frame: 6 months after treatment
Response rate
Time frame: every 6 weeks up to 6 months
overall survival
Time frame: 3 years later initial study start
performance status (quality of life)
European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)-C30 will be used.
Time frame: Every 6 weeks up to 1 year
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