Stomach Neoplasms
Conditions
Keywords
Gastric Cancer
Brief summary
This is a randomized multicenter controlled study of oxaliplatin, leucovorin calcium , plus 5-fluorouracil (FOLFOX) compared with S-1 plus oxaliplatin (SOX) as perioperative chemotherapy for advanced gastric cancer. Hypothesis: SOX is not inferior to FOLFOX as perioperative chemotherapy for advanced gastric cancer.
Interventions
DRUGS-1; Oxaliplatin; 5-Fu; Leucovorin Calcium
FOLFOX: oxaliplatin 130mg/m2 on day 1, CF 400mg/m2 on day 1, 5-Fu 400mg/m2 on day 1; 5-FU 2400 mg/m2 46hr civ regimen repeated every 3 weeks Pre-operative chemotherapy: 2-4 cycles and peri-operative chemotherapy consist of 6 cycles SOX: oxaliplatin 130mg/m2 on day 1, S-1 for 14 days regimen repeated every 3 weeks Pre-chemotherapy: 2-4 cycles, totally 6 cycles of perioperative chemotherapy
Sponsors
Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed gastric adenocarcinoma,diagnosed as locally advanced gastric cancer and primary tumor invades or penetrates serosa * Ambulatory males or females, aged 18-80 years old * ECOG score 0-2 * Given informed consent * Life expectancy more than 3 months * Measurable lesion * Normal cardiac, hepatic, renal, and bone marrow function(WBC:3.5×10\^9/l\ 12×10\^9/l;PLT:\>100×109/l;Bil:\<1.5 fold of upper limit value; ALT/AST:\<2.5 fold of upper limit value;Ccr:\>80ml/min;Cr:1.5mg/dl)
Exclusion criteria
* Prior stomach surgery * Previous cytotoxic chemotherapy, radiotherapy, target therapy or immunotherapy for any tumor * History of another malignancy except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix * distant metastasis(such as No.16 and No.13 lymphnode,liver, lung,brain,bones or peritoneal metastasis) * Severe bleeding * Bowel obstruction, ileus or complete pyloric obstruction * Serious uncontrolled concomitant disease * History of myocardial infarction in 6 months * Woman with on-going pregnancy or breast-feeding, or contemplating pregnancy * Systemic treatment with corticosteroid * Patients judged inappropriate for the trial by the physicians
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall survival | 3-year |
Secondary
| Measure | Time frame |
|---|---|
| progression-free survival(PFS) | 3-year |
| clinical response | 6 or 12 weeks |
| pathological response | within 10 days after surgery |
| Number of Participants with grade 3/4 adverse Events | 6 Years |
Countries
China
Outcome results
None listed