Preoperative S-1 Plus Cisplatin-based Chemoradiotherapy for Locally Advanced Resectable Gastric Adenocarcinoma : Randomized, Phase II Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- pathological response rate
研究概览
简要总结
Gastric cancer is a high incidence in Asia, and one of the leading cause of death in Korea. A cure rate is improving due to early diagnosis. However, the 5-year survival rate of gastric cancer excluding early gastric cancer is about 40 ~ 67%. Therefore, several methods for lowering the recurrence rate have been attempted and concurrent chemoradiotherapy can be considered as a method to lower the recurrence rate of gastric cancer. The purpose of this study is to evaluate the pathologic response rate and safety of patients who underwent surgery after chemoradiotherapy.
详细描述
Gastric cancer is a high incidence in Asia, and one of the leading cause of death in Korea. A cure rate is improving due to early diagnosis. However, the 5-year survival rate of gastric cancer excluding early gastric cancer is about 40 ~ 67%. Therefore, several methods for lowering the recurrence rate have been attempted and concurrent chemoradiotherapy can be considered as a method to lower the recurrence rate of gastric cancer. The purpose of this study is to evaluate the pathologic response rate and safety of patients who underwent surgery after chemoradiotherapy.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 20 years old
- •Histologically confirmed gastric adenocarcinoma
- •clinical stage : resectable gastric cancer
- •advanced confirmed (EGD)
- •extramural infiltration> 1 mm (CT)
- •positive serosa invasion (EUS)
- •Eastern Cooperative Oncology Group performance status 0 or 1
- •no prior chemotherapy and radiotherapy
- •measurable lesion or evaluable lesion according to Response Evaluation Criteria in Solid Tumors version 1.1 criteria
- •Patients with adequate organ function
- •Signed informed consent
排除标准
- •Metastasis esophageal invasion > 3cm
- •inoperable peritoneal seeding disease determined by exploratory laparotomy
- •T4b invading the surrounding organs
- •lymph node metastasis outside the celiac trunk Lymph node and splenic lymph node
- •uncontrolled viral infections (HIV, HBV, HCV)
- •Pregnant or lactating women, women of childbearing potential not employing adequate contraception
- •severe hypersensitivity reactions to S-1, cisplatin
- •Subjects with uncontrolled clinically significant cardiovascular medical history, uncontrolled infection or complication
- •Other co-existing malignancies or malignancies diagnosed within the last 5 years except for curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix
研究组 & 干预措施
SP+CCRT
S-1 20mg/m2, bid (D1~14, D22~35) Cisplatin 30mg/m2/day (W1, 2, 4, 5) radiation 45Gy per 5 weeks
干预措施: TS-1 + cisplatin (Drug)
SP+CCRT
S-1 20mg/m2, bid (D1~14, D22~35) Cisplatin 30mg/m2/day (W1, 2, 4, 5) radiation 45Gy per 5 weeks
干预措施: radiation (Radiation)
结局指标
主要结局
pathological response rate
时间窗: 10 week
to evaluate pathological response rate in locally advanced resectable gastric cancer
次要结局
未报告次要终点