Trials / Terminated

TerminatedNCT01748851

XELOX Versus FOLFOX for Advanced Gastric Cancer (AGC)

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
Phase: Phase 3
Study type: Interventional
Enrollment: 42 (actual)

Sponsor: Dong-A University Hospital · Academic / Other
Sex: All
Age: 20 Years
Healthy volunteers: Not accepted

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

Conditions

Gastric Carcinoma Stage IV

Interventions

Type	Name	Description
DRUG	XELOX	capecitabine 1000mg/m2 bid po D1-D14
DRUG	FOLFOX	5-FU 400mg/m2 iv push D1, 5-FU 1200mg/m2 over 22hr D1,D2

Timeline

Start date: 2012-12-01
Primary completion: 2014-09-01
Completion: 2014-09-01
First posted: 2012-12-13
Last updated: 2014-11-04

Locations

1 site across 1 country: South Korea

Source: ClinicalTrials.gov record NCT01748851. Inclusion in this directory is not an endorsement.