Gastric Carcinoma Stage IV Clinical Trial
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
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
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04442984 -
FOLFOX6 Versus mFOLFIRINOX as First Line Chemotherapy in Metastatic Gastric Cancer or Esophagogastric Junction Adenocarcinoma (Type II-III)
|
Phase 2 |