S-1 Plus Oxaliplatin Compared With Fluorouracil, Leucovorin Calcium Plus Oxaliplatin as Perioperative Chemotherapy for Advanced Gastric Carcinoma

Study Overview
=================
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.

Official Title
-----------------
S-1 Plus Oxaliplatin Compared With Fluorouracil, Leucovorin Calcium Plus Oxaliplatin as Perioperative Chemotherapy for Advanced Gastric Carcinoma: a Multi-center, Open-labeled, Randomized Controlled Trial

Conditions
-----------------
Stomach Neoplasms

Intervention / Treatment
-----------------
* Drug: S-1; Oxaliplatin; 5-Fu; Leucovorin Calcium


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: FOLFOX<br> | Drug: S-1; Oxaliplatin; 5-Fu; Leucovorin Calcium<br>* 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<br>|
| Experimental: SOX<br> | Drug: S-1; Oxaliplatin; 5-Fu; Leucovorin Calcium<br>* 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  | 3-year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gastric Cancer