A Randomized Phase II Multicenter Controlled Study of Oxaliplatin, Calcium Folinate, and 5-Fluorouracil as Neoadjuvant Chemotherapy for Resectable Advanced Gastric Cancer
- ECOG score 0-2
- Ambulatory males or females, aged 30-70 years.
- Histologically confirmed gastric adenocarcinoma, staged preoperatively AJCC/UICC
stage III(T3N1,T2N2,T4N0,T3N2)and IVM0 and operable
- Life expectancy more than 3 months
- Give written informed consent prior to study specific screening procedures, with the
understanding that the patient has the right to withdraw from the study at any time,
- Normal hepatic, renal, and bone marrow function (GPT<2 fold of upper limit value;
WBC>4000/dl, Tbil<1.5mg/dl, Cr<1.5 fold of upper limit value)
- Patients can not bear surgical procedure.
- Pregnant or lactating women or women do not agree conceptive procedures.
- Previous cytotoxic chemotherapy, radiotherapy or immunotherapy except
corticosteroids, for the currently treated gastric cancer.
- History of another malignancy within the last five years except cured basal cell
carcinoma of skin and cured carcinoma in-situ of uterine cervix.
- History of uncontrolled seizures, central nervous system disorders or psychiatric
disability judged by the Investigator to be clinically significant precluding
informed consent or interfering with compliance for oral drug intake.
- Clinically significant (i.e. active) cardiac disease e.g. symptomatic coronary artery
disease, New York Heart Association (NYHA) grade II or greater congestive heart
failure or serious cardiac arrhythmia requiring medication or myocardial infarction
within the last 12 months.
- Organ allografts requiring immunosuppressive therapy.
- Serious uncontrolled intercurrent infections or other serious uncontrolled
- Moderate or severe renal impairment: serum creatinine > 1.5 x upper limit of normal
- Prior unanticipated severe reaction to fluoropyrimidine therapy (with or without
documented DPD deficiency) or patients with known dihydropyrimidine dehydrogenase
- Hypersensitivity to platinum compounds or any of the components of the study
- Received any investigational drug or agent/procedure, i.e. participation in another
trial, within 4 weeks before randomization.
- Unwilling or unable to comply with the protocol for the duration of the study.