NCT00816543已完成2 期
A Single Arm Phase II Feasibility Study of Neoadjuvant Docetaxel, Oxaliplatin and S-1 Chemotherapy in Potentially Operable Gastric or Gastroesophageal Adenocarcinoma.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- R0 resection rate
研究概览
简要总结
The primary objective of this trial is:
- To determine whether it is feasible in locally advanced gastric or gastroesophageal cancer to administer 3 cycles of Docetaxel, Oxaliplatin and S-1 as a chemotherapy scheme and also to determine what toxicities are involved.
The secondary objective of this trial are to describe:
- The disease free survival at one and two years in that subgroup of patients that has undergone a R0 resection.
- The downstaging after 3 cycles of chemotherapy, pCR in that subgroup of patients that have undergone an R0 resection and progression-free survival and overall survival at one and two years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
1
Experimental
3 cycles of neoadjuvant chemotherapy of Docetaxel, Oxaliplatin and S-1. Surgery 5 to 6 weeks after completion of the chemotherapy.
干预措施: DOCETAXEL (Drug)
1
Experimental
3 cycles of neoadjuvant chemotherapy of Docetaxel, Oxaliplatin and S-1. Surgery 5 to 6 weeks after completion of the chemotherapy.
干预措施: S-1 (Drug)
1
Experimental
3 cycles of neoadjuvant chemotherapy of Docetaxel, Oxaliplatin and S-1. Surgery 5 to 6 weeks after completion of the chemotherapy.
干预措施: OXALIPLATIN (Drug)
结局指标
主要结局
R0 resection rate
时间窗: At the end of the treatment period
次要结局
- Physical examination(Every 3 months during the study period)
- Chest X-Ray(Throughout the study period)
- Computed Tomography scan of the abdomen(Every 6 months during the study period)
- Gastrofiberscopy(Every 1 year from the completion of the treatment for 2 years)
- Laboratory analysis(Throughout the study period)
研究者
研究点 (1)
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