Gastric adenocarcinoma
Conditions
Interventions
XELOX:Capecitabine: 1000 mg/m2, take two times a day, 1-14 days
SOX:S-1: 40~60mg bid, 1-14 days
Oxaliplatin combined with S-1 (SOX) during peri operation period of chemotherapy group:S-1 single oral dose, S-1: 40-60mg bid, 1-14 days
Sponsors
Beijing Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. male or female, age over 18 years old; 2. Karnofsky physical condition score were better than 70%; 3. the histologic diagnosis of gastric adenocarcinoma (Lauren type), according to the endoscopic ultrasonography and enhanced CT/MRI examination for clinical staging, staging of cT4b/N+M0, or cT4aN+M0; 4. determine the possible radical resection; 5. research center and the operation can be completed radical lymph node dissection (D2, number of lymph node examination must be at least 15, to ensure that the quality of surgical operation); 6. physical status and organ function is allowed to accept large abdominal operation; 7. baseline blood routine and biochemical indexes meet the following criteria: hemoglobin is greater than or equal to 90g/L; the absolute neutrophil count (ANC) = 1.5*10^9/L; platelet over 100*10^9/L; ALT, AST is less than or equal to 2.5 times the upper limit of normal value; the ALP is less than or equal to 2.5 times the upper limit of normal value; serum total bilirubin <1.5 times the upper limit of normal value; serum creatinine <1 times the upper limit of normal value is greater than or equal to 30g/L; serum albumin; 8. no serious diseases associated with the survival period of 5 years; 9. be willing and able to abide by during the study program; 10. in the study of screening to provide informed consent in writing, and the patient has to know could withdraw from the study at any time without any loss of; 11. agreed to provide blood and histological specimens.
Exclusion criteria
Exclusion criteria: 1. pregnant or lactating women; 2. women of childbearing age at baseline had a positive pregnancy test or a pregnancy test. Menopausal women must stop for at least 12 months, just think it; 3. sexual life (fertility may) men and women do not want to use contraception during the study period; 4. because this is a study of adjuvant chemotherapy, all patients were not on any signs of metastasis; 5. for the treatment of the gastric cancer had received cytotoxic chemotherapy, radiotherapy or immunotherapy, corticosteroids except; 6.There are other malignant disease in the last 5 years, except for skin cancer cure cervical cancer; 7. there are disorders of central nervous system disease or epilepsy, mental control, by the researchers to determine its clinical severity will prevent the signing of informed consent the compliance of oral drugs in patients with books or influence; 8. severe clinical (activity) of heart disease, such as coronary heart disease, symptoms of New York Heart Association (NYHA) class II or more severe congestive heart failure or severe arrhythmia drug intervention (see Appendix 12), or within the last 12 months have a history of mi; 9. upper gastrointestinal obstruction or abnormal physiological function or from malabsorption syndrome, may affect the absorption of /S-1 capecitabine capecitabine; 10. patients with peripheral nerve disease, known NCI CTC AE 1. But only the deep tendon reflex (DTR) performance of the patients disappeared without exclusion; 11. organ transplantation require immunosuppressive therapy; 12. severe uncontrolled repeated infection, or other severe uncontrolled concomitant disease; 13. moderate or severe renal impairment [creatinine clearance rate is equal to or lower than 50 ml/min (calculated according to Cockroft and Gault equation, see Appendix 4), and serum creatinine. The upper limit of normal (ULN); 14. with two hydrogen known dihydropyrimidine dehydrogenase (DPD) deficiency; 15. the platinum compounds or any component of drug allergy; 16. were randomly assigned within 4 weeks before study drug or preparation treated / (in other test).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3 year disease free survival rate; | — |
Countries
China
Contacts
Public ContactJi Jiafu; Shen Lin
Outcome results
None listed