S-1 and Irinotecan in Treating Patients Who Are Undergoing Surgery for Locally Advanced Stomach Cancer
This trial is active, not recruiting.
|Treatments||irinotecan hydrochloride, tegafur-gimeracil-oteracil potassium, adjuvant therapy, conventional surgery, neoadjuvant therapy|
|Sponsor||Fukushima Medical University Hospital|
|Start date||September 2004|
|End date||August 2008|
|Trial size||70 participants|
|Trial identifier||NCT00134095, CDR0000439474, FMUH-UHA-GC04-02|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Noshiro, Japan||Yamamoto Kumiai General Hospital||no longer recruiting|
|Asahikawa, Japan||Asahikawa Kosei General Hospital||no longer recruiting|
|Kobe, Japan||Kobe City General Hospital||no longer recruiting|
|Morioka, Japan||Iwate Medical University Hospital||no longer recruiting|
|Tsuruoka, Japan||Tsuruoka Municipal Shonai Hospital||no longer recruiting|
|Fukushima, Japan||Fukushima Medical University Hospital||no longer recruiting|
|Yamagata, Japan||Yamagata Prefectural Central Hospital||no longer recruiting|
Historical tumor shrinkage
Male or female participants from 20 years up to 75 years old.
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
|Official title||Phase II Clinical Study of Preoperative S-1/CPT-11 Combination Chemotherapy in Patients With Locally Advanced Gastric Cancer|
|Description||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.|
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