Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2025-12-24 @ 11:42 PM
NCT ID:
NCT01748851
Brief Summary:
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.
Detailed Description:
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:
NCT01748851
Study Brief:
Protocol Section:
NCT01748851