A Prospective Multi-center Randomized Clinical Trial to Compare Survival Rates and Quality of Life According to Follow-up Period in Patients Who Underwent Radical Gastrectomy for Advanced Gastric Cancer (STOFOLUP Trial)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 886
- 试验地点
- 16
- 主要终点
- 3-year overall survival
研究概览
简要总结
This study is a multi-center, prospective, randomized controlled study. The aim of this study is to compare survival rates and to observe quality of life and nutritional status according to follow-up period in patients who underwent radical gastrectomy for stage 2 or 3 gastric cancer.
详细描述
The hypothesis of this study is that the survival rates would be different between the 3 months and 6 months follow-up groups. The investigators expected survival differences of 6% and the anticipated 3-year overall survival is 83% in the 6 months follow-up group based on the previous 3 phase clinical trial. On the basis of this hypothesis, the sample size was calculated as 886 patients.
Patients who were diagnosed as stage 2 or 3 gastric cancer after gastrectomy will be assigned to 3 months or 6 months follow-up group. The planned examinations including blood test, X-ray , CT, endoscopy, and nutritional markers will be performed according to the protocol and each patients will be followed up for 3 years after enrollment.
The primary endpoint is 3 year overall survival and secondary endpoints are other survivals such as 3-year disease-free survival and gastric cancer specific survival, quality of life, and nutritional parameters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 19 years or more
- •Patients who are diagnosed with pathological stage II or III gastric adenocarcinoma according to the AJCC 8th edition
- •Patients who can understand all information about the trial and decide for themselves whether to participate in this study
排除标准
- •Vulnerable patients such as pregnant and intellectual disability
- •Patients who cannot undergo CT owing to poor kidney function or severe adverse effects
- •Patients who are already in another study and cannot follow the schedule for this trial
- •Patients who are diagnosed with a cancer other than gastric cancer within five years before the gastrectomy
- •Patients being treated for a cancer other than gastric cancer
研究组 & 干预措施
3 months follow-up
Patients will be follow-up every 3 months after gastrectomy.
干预措施: Computed tomography, Chest X-ray, and blood test (Diagnostic Test)
6 months follow-up
Patients will be follow-up every 6 months after gastrectomy.
干预措施: Computed tomography, Chest X-ray, and blood test (Diagnostic Test)
结局指标
主要结局
3-year overall survival
时间窗: 3 years after surgery
Death from any cause is defined as an event.
次要结局
- Incidence of iron deficiency anemia(3 years after surgery)
- 3-year recurrence-free survival rate(3 years after surgery)
- 3-year gastric cancer specific survival rate(3 years after surgery)
- 3-year post-recurrence survival rate(3 years after surgery)
- Summary score of KOQUSS-40 questionnaire(3 years after surgery)
- Summary score of EORTC QLQ C30(3 years after surgery)
- Summary score of EORTC QLQ STO22(3 years after surgery)
- Difference of body weight (kg)(3 years after surgery)
- Incidence of vitamin B12 deficiency(3 years after surgery)
研究者
Keun Won Ryu
Principal Investigator
National Cancer Center, Korea