NCT00134095Unknown2 期
Phase II Clinical Study of Preoperative S-1/CPT-11 Combination Chemotherapy in Patients With Locally Advanced Gastric Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 70
- 试验地点
- 7
- 主要终点
- Historical tumor shrinkage
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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:
- •Performance status
- •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
- •AST and ALT ≤ 100 U/L
- •Bilirubin ≤ 1.5 mg/dL
- •Creatinine normal OR
- •Creatinine clearance ≥ 50 mL/min
- •PaO_2 > 60 mm Hg on room air
- •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
- •No prior surgery for gastric cancer
- •No other prior therapy for gastric cancer
排除标准
- 未提供
结局指标
主要结局
Historical tumor shrinkage
Tumor shrinkage
Overall survival
Progression-free survival
Median survival
Safety
次要结局
未报告次要终点
研究者
研究点 (7)
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