S-1 and Irinotecan in Treating Patients Who Are Undergoing Surgery for Locally Advanced Stomach Cancer

Study Overview
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Brief Summary
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RATIONALE: Drugs used in chemotherapy, such as S-1 and irinotecan, 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 completely removed. PURPOSE: This phase II trial is studying how well giving S-1 together with irinotecan works in treating patients who are undergoing surgery for locally advanced stomach cancer.

Detailed Description
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OBJECTIVES: Primary Determine the efficacy of neoadjuvant S-1 and irinotecan in patients with locally advanced gastric cancer. Secondary Determine the histological response in patients treated with this regimen. Determine the overall survival of patients treated with this regimen. Determine the progression-free survival of patients treated with this regimen. Determine the toxicity of this regimen in these patients. Determine postoperative morbidity in patients treated with this regimen. Determine the rate of potentially curative surgery in patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive oral S-1 on days 1-21 and irinotecan IV over 90 minutes on days 1 and 15. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients then undergo gastrectomy with lymphadenectomy. After surgery, patients resume treatment with S-1 alone as before for 1 year. PROJECTED ACCRUAL: A total of 70 patients will be accrued for this study.

Official Title
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Phase II Clinical Study of Preoperative S-1/CPT-11 Combination Chemotherapy in Patients With Locally Advanced Gastric Cancer

Conditions
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Gastric Cancer

Intervention / Treatment
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* Drug: irinotecan hydrochloride
* 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 Locally advanced disease Clinical stage T3-4, N0-3, M0 (according to the Japanese gastric cancer classification) Planning to undergo curative surgery after neoadjuvant chemotherapy PATIENT CHARACTERISTICS: Age 20 to 75 Performance status ECOG 0-1 Life expectancy Not specified 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 Renal Creatinine normal OR Creatinine clearance ≥ 50 mL/min Pulmonary PaO_2 > 60 mm Hg on room air Other Able to swallow oral medication PRIOR CONCURRENT THERAPY: Biologic therapy No prior biologic therapy for gastric cancer Chemotherapy No prior chemotherapy for gastric cancer Endocrine therapy No prior endocrine therapy for gastric cancer 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
Maximum Age: 75 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
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: irinotecan hydrochloride|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 |
| --- | --- | --- |
| Tumor shrinkage |  |  | 
| Historical tumor shrinkage |  |  | 
| Overall survival |  |  | 
| Progression-free survival |  |  | 
| Median survival |  |  | 
| Safety |  |  | 

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