NCT00182611已完成3 期
Phase III Clinical Study of Preoperative S-1/CDDP Combination Chemotherapy in Patients With Potentially Resectable Stage III Advanced Gastric Cancer
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 12
- 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 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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
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, 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:
- •20 and over
- •Performance status
- •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
- •AST and ALT ≤ 2.5 times upper limit of normal
- •Bilirubin ≤ 1.5 mg/dL
- •Creatinine clearance ≥ 50 mL/min
- •Arterial oxygen pressure (PaO_2) ≥ 70 mm Hg on room air
- •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
- •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
- Progression-free survival (PFS)
- Postoperative PFS
- Surgical/pathological curative resection
- Death related to treatment
- Death related to operation
- Postoperative complications
- Adverse events
研究者
研究点 (12)
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