Phase Ⅱ Study of S-1 Combined With Oxaliplatin (SOX)Verse S-1 Combined With Cisplatin(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.