A PhaseⅡ Study: SOX vs SP in Adjuvant Chemotherapy After D2 Surgery

Inclusion Criteria:

• histologically confirmed Phase III adenocarcinoma of gastric and esophageal-gastric junction ( AJCC 7th)
• without previous treatment, including radiotherapy, chemotherapy and immunotherapy
• Hb≥90g/L,WBC 4×109/L-10×109/L,ANC≥2×109/L,Platelet≥100×109/L
• creatinine≤1 UNL
• total bilirubin≤1.5 UNL,AST(SGOT),ALT(SGPT) and ALP≤2.5 UNL
• ECOG score 0 - 2
• take chemotherapy for 8 weeks after surgery
• older than 18 years
• can be followed up, good compliance
• can take medicine orally
• having signed informed consent

Exclusion Criteria:

• combined disease lead to Life Expectancy less than 3 years
• any evidence to show metastasis,including cancer cells in peritoneal fluid
• inability to take oral medication for difficult to swallow, intestinal obstruction，active intestinal blooding or perforation
• previous treatment,including cytotoxic chemotherapy, radio chemotherapy or immunotherapy ( except corticosteroid hormone）
• operation within 4 weeks, or not recovered from last major operation
• allergy with fluorouracil
• allergy with Platinum or any composition in research drugs
• uncontrollable seizure disorder，central nervous system disease or mental disorders, and has clinical significance by judgement of researchers, or can influnce understanding of informed consent or compliance to take orally drugs
• in the past 12 months, has clinical significant heart disease(active),such as symptomatic coronary heart disease, > =Stage II congestive cardiac failure;congestive heart failure as NYHA standard, or serious arrhythmias need take medicine( as Appendix 10th),or myocardical infarction.
• pregnancy， lactation， women in child-bearing period and her spouses reject to take effictive method to conraception
• other previous malignancy within 5 years, except healed skin basal cell carcinoma and carcinoma in cervix
• peripheral neuropathy> grade 1 of CTCAEv3, except the neural abnormality patients who only lose deep tendon reflex（DTRs）.
• serious complicated infection or other complicated diseases and hard to controll.
• As one of belowing:
• ANC < 2×109/L
• Platelet<100×109/L
• total bilirubin>1.5 UNL
• ALAT、ASAT > 2.5 x ULN
• ALP> 2.5 x ULN
• Any investigational agent within the past 28 days. That is the patient had jioned another trial.