A Randomized, Multicenter, Open-label, Phase III Trial of Docetaxel and S1 (DS) Versus S1 and Cisplatin (SP) in Curatively Resected (D2) Gastric Cancer of Stage IIIB/IV (M0)
试验速览
- 阶段
- 3 期
- 入组人数
- 166
- 试验地点
- 1
- 主要终点
- 3-year disease free survival(DFS)
研究概览
简要总结
Docetaxel was the first drug that showed survival benefits when added to the CF regimen, but it was very toxic. Docetaxel is also has a synergistic anti-cancer effect with S-1, in phase I/II studies. The use of a docetaxel plus S-1 combination as first-line chemotherapy for advanced gastric cancer achieved response rates of 46~56% and a median survival time of 14.0~14.3 months.
Based upon this background, the aim of this study is to detect a significant increase in 3 year DFS of disease for the test group (DS) relative to the Control group (SP).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 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
- •Histologically proven, Stage IIIb/ IIIc curatively resected gastric carcinoma
- •ECOG performance status 0-1
- •Curatively resected advanced gastric cancer patients of stage IIIb/IIIc
- •D2 lymph node dissection with R0 surgery
- •Signed informed consent
排除标准
- •Subjects with documented distant metastasis.
- •Malabsorption syndrome or disease significantly affecting gastrointestinal function
- •Patients with other uncontrolled systemic illness, e.g. infection, poorly controlled HTN
- •History of other malignancy. Subjects who have been disease-free for 5 years or subjects with successfully treated in situ carcinoma are eligible.
- •Subjects with preoperative/adjuvant other cancer treatment, such as chemotherapy, immunotherapy and radiotherapy
研究组 & 干预措施
DS(Docetaxel with S-1)
Docetaxel with S-1
干预措施: DS (Drug)
SP(S-1 with cisplatin)
S-1 with cisplatin
干预措施: SP (Drug)
结局指标
主要结局
3-year disease free survival(DFS)
时间窗: 3 years
Tumor assessments with chest X-rays and CT or MRI scan will be done at 6 months after randomization (after the end of the treatment period), then every 3 months for the first 2 years after randomization and then every 6 months for coming 3 years then one year basis until completion of the study.
次要结局
未报告次要终点