Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2025-12-25 @ 9:33 PM
Study NCT ID:
NCT01748851
Status:
TERMINATED
Last Update Posted:
2014-11-04
First Post:
2012-12-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
XELOX Versus FOLFOX for Advanced Gastric Cancer (AGC)
Sponsor:
Dong-A University Hospital
Organization:
Study Overview
Official Title:
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
Status:
TERMINATED
Status Verified Date:
2014-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Poor enrollment of patients
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| ML27924 | OTHER_GRANT | Roche Korea Company | View |