Status:
COMPLETED
Continuous Infusion of FU Combined With Epirubicin and Oxaliplatin in Patients With A/MGC
Lead Sponsor:
Fudan University
Conditions:
Gastric Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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 unre...
Detailed Description
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 s...
Eligibility Criteria
Inclusion
- Histologically confirmed advanced or metastatic adenocarcinoma of the stomach
- ECOG performance scale ≤2
- At least one measurable lesion (larger than 10 mm in diameter by spiral CT scan)
- Adequate hepatic, renal, heart, and hematologic functions (platelets \>80×109/L, neutrophil\>2.0×109/L, serum creatinine ≤1.5mg/dl, total bilirubin within upper limit of normal(ULN), and serum transaminase≤2.5×the ULN)
Exclusion
- Pregnant or lactating women
- Concurrent cancer
- History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
- Neuropathy, brain, or leptomeningeal involvement
- Clinically relevant coronary artery disease or a history of a myocardial infarction within the last 12 months or high risk/uncontrolled arrhythmia
- Uncontrolled significant comorbid conditions and previous radiotherapy
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
163 Patients enrolled
Trial Details
Trial ID
NCT00767377
Start Date
May 1 2007
End Date
March 1 2013
Last Update
October 16 2013
Active Locations (1)
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1
Fudan University Cancer Hospital
Shanghai, China, 200032