The Multi-national Multi-institutional Phase 2 Trial for Conversion Surgery in Stage IV or Unresectable Gastric Cancer
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- 3-year overall survival
研究概览
简要总结
This study aims to identify the safety and the survival benefit of the conversion surgery in stage IV or unresectable gastric cancer. The study designed single-arm phase II trial. All the patients would undergo curative-intent radical gastrectomy after palliative chemotherapy if the tumor responded to the chemotherapy. Primary endpoint was three-year overall survival. Secondary endpoints included short-term postoperative outcomes within 30 days, three-year relapse free survival, and success rate of conversion surgery (rate of R0 resection).
详细描述
The survival rate of patients with stage IV gastric cancer (GC) is very low. Recently, several retrospective studies about conversion surgery have been introduced. The results of the studies showed around 30~40% of three-year survival rate in conversion surgery group. Eight institutions in Catholic University of Korea analyzed 419 stage IV GC patients, and they had divided into four groups: chemotherapy only, chemotherapy followed by gastrectomy, gastrectomy followed by chemotherapy, and best supportive care group. The group of gastrectomy followed by chemotherapy, which is similar with conversion surgery, showed 40% of three-year survival rate. However, the study included only small number of patients who were in conversion surgery group, and had several biases. Thus, we planned multi-national, multi-center phase II trial for conversion surgery in stage IV or unresectable GC.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gastric adenocarcinoma
- •Stage IV or unresectable gastric cancer was diagnosed by pre-operative evaluation including endoscopy, endoscopic ultrasound, Computed tomography (CT), Positron emission tomography-computed tomography (PET CT), or staging laparoscopy
- •Partial or complete response to chemotherapy
- •Eastern Cooperative Oncology Group (ECOG) score <3
- •Who agreed to enroll the study
排除标准
- •Synchronous or metachronous malignancy
- •remnant gastric cancer
- •BMI less than 18.5
- •Pregnancy
研究组 & 干预措施
Conversion surgery
Palliative chemotherapy followed by radical gastrectomy
干预措施: Conversion surgery (Procedure)
结局指标
主要结局
3-year overall survival
时间窗: 3 years after the surgery
3-year overall survival after conversion surgery
次要结局
- Complication(30 days after the surgery)
- Response rate of chemotherapy(Operation day)
- 3-year disease free survival(3 years after the surgery)
- Success rate of conversion surgery(30 days after the surgery)
研究者
Cho Hyun Park
Professor
Seoul St. Mary's Hospital