Spots Global Cancer Trial Database for Survival Rates and Quality of Life According to Follow-up Period After Gastrectomy for Gastric Cancer (STOFOLUP)
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Trial Identification
Brief Title: Survival Rates and Quality of Life According to Follow-up Period After Gastrectomy for Gastric Cancer (STOFOLUP)
Official Title: 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)
Study ID: NCT04740346
Interventions
Study Description
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.
Keywords
Eligibility
Minimum Age: 19 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
National Cancer Center, Korea, Goyang, Gyeonggi-do, Korea, Republic of
Dongnam Institute of Radiological and Medical Sciences, Busan, , Korea, Republic of
Kosin University Gospel Hospital, Busan, , Korea, Republic of
Gyeongsang National University Changwon Hospital, Changwon, , Korea, Republic of
Keimyung University Dongsan Hospital, Daegu, , Korea, Republic of
Kyungpook National University Chilgok Hospital, Daegu, , Korea, Republic of
Chonnam National University Hwasun Hospital, Hwasun, , Korea, Republic of
Gyeongsang National University Hospital, Jinju, , Korea, Republic of
CHA Bundang Medical Center, Seongnam, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Kangbuk Samsung Hospital, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Seoul St. Mary's Hospital, Seoul, , Korea, Republic of
Yonsei Univeristy College of Medicine, Seoul, , Korea, Republic of
Ajou University School of Medicine, Suwon, , Korea, Republic of
Contact Details
Name: Keun Won Ryu, MD PhD
Affiliation: National Cancer Center, Korea
Role: PRINCIPAL_INVESTIGATOR
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