A Phase II Trial of Adjuvant Chemotherapy With S-1 Plus Oxaliplatin for Locally Advanced Gastric Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- 3-year disease-free survival
研究概览
简要总结
Patients with advanced gastric cancer have showed poor prognosis. Only 81% of the patients could underwent curative surgery. In those, about 60% of patients would survive after 5 years from the surgery. As a result, role of chemotherapy has been increased. In ACTS-GC trial, S-1 adjuvant therapy after D2 gastrectomy increased overall survival rate in advanced gastric cancer patients. However, subgroup analysis showed that S-1 adjuvant therapy was insufficient in patients with stage III or IV (according to the AJCC 6th criteria) gastric cancer. In addition, CLASSIC trial demonstrated that oxaliplatin plus capecitabine adjuvant therapy could increase disease-free survival after D2 gastrectomy in advanced gastric cancer patients. Notwithstanding these trial, optimal adjuvant regimen of advanced gastric cancer has not been established. We aimed to evaluate efficacy of S-1 plus oxaliplatin as adjuvant chemotherapy after D2 gastrectomy in stage III (according to the AJCC 7th criteria) gastric cancer patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age, between 19 and 75
- •Histologically proven advanced gastric cancer
- •R0 resection after D2 gastrectomy
- •Stage III (according to the AJCC 7th criteria)
- •ECOG status 0 to 2
排除标准
- •Malignancy history other than gastric cancer
- •Previous chemotherapy history for gastric cancer
- •Previous radiotherapy history for gastric cancer
- •Pregnancy or breast milk feeding
- •Grade 3 or more of neuropathy
- •Active infection
- •Severe hepatic dysfunction
- •Severe renal dysfunction
- •Severe bone marrow dysfunction
- •Significant neurologic or psychologic disease
- •Inadequate condition for receiving chemotherapy due to significant systemic disease
- •Patients who receives drugs which can be interacted with S-1
研究组 & 干预措施
Treatment group
干预措施: S-1 plus oxaliplatin (Drug)
结局指标
主要结局
3-year disease-free survival
时间窗: 3 years from the surgery
3-year disease-free survival will be assessed by imaging study including CT and PET.
次要结局
未报告次要终点