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)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 886
- Locations
- 17
- Primary Endpoint
- 3-year overall survival
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
3-year overall survival
Time Frame: 3 years after surgery
Death from any cause is defined as an event.
Secondary Outcomes
- 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)
- Incidence of vitamin B12 deficiency(3 years after surgery)
- Difference of body weight (kg)(3 years after surgery)
Investigators
Keun Won Ryu
Principal Investigator
National Cancer Center, Korea