NCT00088816Unknown2 期
Phase II Clinical Study of Preoperative S-1/CDDP Combination Chemotherapy in Patients With Advanced Gastric Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 50
- 试验地点
- 7
- 主要终点
- Overall survival
研究概览
简要总结
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.
详细描述
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.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed gastric adenocarcinoma
- •Stage IV disease meeting 1 of the following staging criteria according to Japanese gastric cancer classification:
- •CT scan and laparoscopic staging required
- •PATIENT CHARACTERISTICS:
- •20 and over
- •Performance status
- •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
- •AST and ALT ≤ 2.5 times upper limit of normal
- •Bilirubin ≤ 1.5 mg/dL
- •Creatinine clearance ≥ 50 mL/min
- •PaO_2 ≥ 70 mm Hg on room air
- •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
- •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
Overall survival
次要结局
- Time to progression
- Tumor response
- Death related to treatment
- Histological response
- Postoperative complications
- Surgical/pathological curative resection
- Types of initial recurrence
- Adverse events
研究者
研究点 (7)
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