Gastric Cancer
Conditions
Brief summary
The purpose of this study is to determine whether S-1 and oxaliplatin as neoadjuvant chemotherapy may improve survival benefit compared with control.
Interventions
DRUGDrug: S-1 and oxaliplatin
Drug:S-1:80mg/m2;oxaliplatin 130mg/m2
Sponsors
Chinese PLA General Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. DISEASE CHARACTERISTICS: Histologically confirmed gastric adenocarcinoma Locally advanced disease:Clinical stage T3-4, N0-3, M0 (according to the Japanese gastric cancer classification) 2. Planning to undergo gastric cancer D2 surgery after neoadjuvant chemotherapy 3. Age:20 to 75 4. Performance status:ECOG 0-2 5. Life expectancy:Not specified 6. Hematopoietic:WBC 4,000-12,000/mm\^3；Granulocyte count ≥ 2,000/mm\^3；Platelet count ≥ 100,000/mm\^3；Hemoglobin ≥ 9.0 g/dL;Hepatic:AST and ALT ≤ 100 U/L；Bilirubin ≤ 1.5 mg/dL 7. Adequate organ function 8. Able to swallow oral medication 9. Written informed consent
Exclusion criteria
1. Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ 2. Pregnant or breast-feeding women 3. Severe mental disease 4. Systemic administration of corticosteroids, flucytosine, phenytoin or warfarin 5. Other severe complications such as paralytic ileus, intestinal pneumonitis, pulmonary fibrosis, or ischemic heart disease 6. Myocardial infarction within six disease-free months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall survival | 5 years |
Secondary
| Measure | Time frame |
|---|---|
| response rate | 3 months |
Countries
China
Contacts
Primary ContactL Chen, MD
Outcome results
None listed