drugset / Trial / NCT00767377

Continuous Infusion of FU Combined With Epirubicin and Oxaliplatin in Patients With A/MGC

NCT00767377 ↗

Phase 2 Completed 163 enrolled Fudan University
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the efficacy and tolerability of the combination of epirubicin, oxaliplatin and 5-day continuous infusional 5-fluorouracil (EOF5 regimen) in patients with unresectable advanced or metastatic gastric cancer (A/MGC). Since Mar 2011, two addition second endpoints was added to the trial, one was to compare the consistence of two types of PET Scan evaluation with routine CT Scan evaluation, the other was to search for predictor factors of clinical results ( ORR,PFS and OS) with Pharmacogenomics methods. This modification was approved by the Ethic Committee of Fudan University Cancer Hospital, and the approval number was IRB50-15-1101A.

Timeline

Start
2007-05
Primary completion
2012-07
Completion
2013-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Epirubicin Small molecule 50 mg/m2 —
Subject Oxaliplatin Small molecule 130 mg/m2 —
Subject fluorouracil Small molecule 375 mg/m2 —
Subject fluorouracil Small molecule 425 mg/m2 —

Indications