S-1 and Cisplatin Before Surgery in Treating Patients With Stage IV Gastric Cancer

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Drugs used in chemotherapy, such as S-1 and cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Giving combination chemotherapy before surgery may shrink the tumor so that it can be removed. PURPOSE: This phase II trial is studying how well giving S-1 together with cisplatin works in treating patients who are undergoing surgery for stage IV gastric cancer.

Detailed Description
-----------------
OBJECTIVES: Primary Determine the efficacy and feasibility of neoadjuvant chemotherapy comprising S-1 and cisplatin in patients with stage IV gastric adenocarcinoma. Determine the overall survival of patients treated with this regimen. Secondary Determine the time to progression and types of initial recurrence in patients treated with this regimen. Determine tumor response in patients treated with this regimen. Determine mortality and morbidity related to treatment in these patients. Determine the toxicity of this regimen in these patients. OUTLINE: This is a multicenter study. Patients receive oral S-1 on days 1-21 and cisplatin IV over 2 hours on day 8. Treatment repeats every 35 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients then undergo gastrectomy with lymphadenectomy. Patients resume oral S-1 after surgery. PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

Official Title
-----------------
Phase II Clinical Study of Preoperative S-1/CDDP Combination Chemotherapy in Patients With Advanced Gastric Cancer

Conditions
-----------------
Gastric Cancer

Intervention / Treatment
-----------------
* Drug: cisplatin
* Drug: tegafur-gimeracil-oteracil potassium
* Procedure: adjuvant therapy
* Procedure: conventional surgery
* Procedure: neoadjuvant therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Histologically confirmed gastric adenocarcinoma Stage IV disease meeting 1 of the following staging criteria according to Japanese gastric cancer classification: T4, N2 T4, N3 P1, CY1 CT scan and laparoscopic staging required PATIENT CHARACTERISTICS: Age 20 and over Performance status ECOG 0-1 Life expectancy Not specified Hematopoietic WBC ≥ 4,000/mm^3 AND < 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 ≤ 2.5 times upper limit of normal Bilirubin ≤ 1.5 mg/dL Renal Creatinine clearance ≥ 50 mL/min Pulmonary PaO_2 ≥ 70 mm Hg on room air Other Able to swallow oral medication PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy No prior chemotherapy for gastric cancer Endocrine therapy Not specified Radiotherapy No prior radiotherapy for gastric cancer Surgery No prior surgery for gastric cancer Other No other prior therapy for gastric cancer

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

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

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

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

Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: cisplatin|nan|
|Drug: tegafur-gimeracil-oteracil potassium|nan|
|Procedure: adjuvant therapy|nan|
|Procedure: conventional surgery|nan|
|Procedure: neoadjuvant therapy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to progression |  |  | 
| Tumor response |  |  | 
| Death related to treatment |  |  | 
| Histological response |  |  | 
| Postoperative complications |  |  | 
| Surgical/pathological curative resection |  |  | 
| Types of initial recurrence |  |  | 
| Adverse events |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stage IV gastric cancer, adenocarcinoma of the stomach