S-1 and Cisplatin in Treating Patients Who Are Undergoing Surgery for Stage III Stomach Cancer

Study Overview
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Brief Summary
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RATIONALE: Drugs used in chemotherapy, such as S-1 and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Giving chemotherapy before surgery may shrink the tumor so that it can be removed. It is not yet known whether giving S-1 together with cisplatin before surgery is more effective than surgery followed by S-1 in treating stomach cancer. PURPOSE: This randomized phase III trial is studying how well giving S-1 together with cisplatin before surgery works compared to surgery followed by S-1 in treating patients with stage III stomach cancer.

Detailed Description
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OBJECTIVES: Primary Compare the overall survival of patients with potentially resectable stage III gastric cancer treated with neoadjuvant S-1 and cisplatin followed by gastrectomy and adjuvant S-1 vs no neoadjuvant chemotherapy before gastrectomy and adjuvant S-1. Secondary Compare the progression-free survival of patients treated with these regimens. Compare the curative resection rates in patients treated with these regimens. Compare the safety of these regimens, in terms of postoperative complications, adverse events, and treatment- or surgery-related mortality rate, in these patients. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to disease stage (T3 vs T4) and ECOG performance status (0 vs 1). Patients are randomized to 1 of 2 treatment arms. Arm I (control): Patients undergo gastrectomy with D2+ lymph node dissection. Patients then receive adjuvant oral S-1. Arm II (neoadjuvant therapy): Patients receive neoadjuvant 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. Patients then undergo surgery and receive adjuvant S-1 as in arm I. PROJECTED ACCRUAL: A total of 100 patients (50 per treatment arm) will be accrued for this study.

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

Conditions
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Gastric Cancer

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


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed gastric adenocarcinoma, including type II or type III adenocarcinoma of the esophagogastric junction Stage III disease T3 or T4 and/or N2 No stage IV disease Helical CT scan and laparoscopic staging required Potentially resectable disease PATIENT CHARACTERISTICS: Age 20 and over Performance status ECOG 0-1 Life expectancy Not specified Hematopoietic WBC ≥ 4,000/mm³, but < 12,000/mm³ Granulocyte count ≥ 2,000/mm³ Platelet count ≥ 100,000/mm³ 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 Arterial oxygen pressure (PaO_2) ≥ 70 mm Hg on room air Other Able to take oral medications 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
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized


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?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival (PFS) |  |  | 
| Postoperative PFS |  |  | 
| Surgical/pathological curative resection |  |  | 
| Death related to treatment |  |  | 
| Death related to operation |  |  | 
| Postoperative complications |  |  | 
| Adverse events |  |  | 

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