Phase II Trial of Epirubicin, Oxaliplatin and 5-day 5-fluorouracil in Patients With Advanced and Metastatic Gastric Cancer
ECF regimen is considered as a reference regimen for gastric cancer in Europe. Now, no
regimen has been proved to be more effective while less toxicity than ECF regimen.
Oxaliplatin has demonstrated synergy with 5-FU in vitro, in vivo, and in the clinical
setting in advanced colorectal cancer. It presents a better toxicity profile than cisplatin.
Recently some studies used combination regimens of oxaliplatin, folinic acid, and continuous
infusion 5-FU for about 44 hours (e.g FOLFOX4 ) to treat A/MGC, and yielded good response
rates and median overall survival times while resulting in lower rates of grade 3-4 adverse
events. Therefore, it is logical to modify ECF regimen with oxaliplatin replacing cisplatin
and a short-term FU infusion replacing 21-day FU infusion. Our objective is to evaluate
whether the EOF5 regimen is less toxicity while is comparable effective as ECF regimen.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Time to progression
every six weeks
No
Jiliang Ying, M.D
Principal Investigator
Fudan University
China: Ethics Committee
EOF-MGC
NCT00767377
May 2007
December 2011
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