[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100419332":3},{"organization":4,"outcomesModule":7,"designInfo":42,"detailedDescription":48,"studyPopulation":41,"armGroups":49,"interventions":61,"overallOfficials":67,"centralContacts":71,"locations":77,"responsibleParty":306,"collaborators":309,"id":312,"slug":41,"hasResults":313,"nctId":314,"briefTitle":315,"officialTitle":316,"acronym":41,"eligibilityCriteria":317,"healthyVolunteers":313,"sex":318,"minAge":319,"maxAge":41,"enrollmentInfo":320,"targetDuration":41,"studyType":323,"phases":324,"briefSummary":326,"conditions":327,"keywords":41,"overallStatus":79,"whyStopped":41,"lastUpdateSubmitDate":331,"lastUpdatePostDateStruct":332,"startDateStruct":335,"completionDateStruct":337,"leadSponsor":339,"locationsCount":340},{"fullName":5,"class":6},"National Cancer Center, Korea","OTHER_GOV",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":41},[9],{"measure":10,"description":11,"timeFrame":12},"3-year overall survival","Death from any cause is defined as an event.","3 years after surgery",[14,17,20,23,26,29,32,35,38],{"measure":15,"description":16,"timeFrame":12},"3-year recurrence-free survival rate","Death from any cause and gastric cancer recurrence are an event.",{"measure":18,"description":19,"timeFrame":12},"3-year gastric cancer specific survival rate","Death from gastric cancer is the only event.",{"measure":21,"description":22,"timeFrame":12},"3-year post-recurrence survival rate","from recurrence detection date to last follow-up date (or death)",{"measure":24,"description":25,"timeFrame":12},"Summary score of KOQUSS-40 questionnaire","KOQUSS-40 consists of 8 domains with 40 questions for quality of life and post-gastrectomy symptoms. We will calculate the KOQUSS-40 summary score of each group and compare them between the two groups. The summary score is defined as the mean of eight symptom domains (Indigestion, dysphagia, reflux, dumping syndrome, bowel habit change, constipation, psychological factors, and worry about cancer). The minimum and maximum values are 0 and 100, and higher scores mean a better quality of life.",{"measure":27,"description":28,"timeFrame":12},"Summary score of EORTC QLQ C30","EORTC QLQ C30 consists of 15 domains with 30 questions for quality of life of cancer patients. The 15 domains consist of five functional scales (physical, role, cognitive, emotional, and social functioning), a global QOL scale, three symptom scales (fatigue, nausea and vomiting, and pain), and six single items (appetite loss, diarrhea, dyspnea, constipation, insomnia, financial impact).\n\nWe will calculate the EORTC QLQ C30 summary score of each group and compare them between the two groups. The summary score is defined as the mean of 13 domains (excluding global QOL scale and financial impact). The minimum and maximum values are 0 and 100, and higher scores mean a better quality of life.",{"measure":30,"description":31,"timeFrame":12},"Summary score of EORTC QLQ STO22","EORTC QLQ STO22 consists of 9 domains with 22 questions for stomach cancer patients' symptoms. The 9 domains consist of five symptom scales (dysphagia, pain, reflux symptom, eating restriction, anxiety), four single items (having a dry mouth, taste, body image, and hair loss).\n\nWe will calculate the EORTC QLQ STO22 summary score of each group and compare them between the two groups. The summary score is defined as the mean of 9 domains. The minimum and maximum values are 0 and 100, and higher scores mean a better quality of life.",{"measure":33,"description":34,"timeFrame":12},"Difference of body weight (kg)","Difference of body weight between preoperative and postoperative 3 year values",{"measure":36,"description":37,"timeFrame":12},"Incidence of iron deficiency anemia","Incidence of iron deficiency anemia for the 3 year follow-up after gastrectomy",{"measure":39,"description":40,"timeFrame":12},"Incidence of vitamin B12 deficiency","Incidence of vitamin B12 deficiency for the 3 year follow-up after gastrectomy",null,{"allocation":43,"interventionModel":44,"interventionModelDescription":41,"primaryPurpose":45,"observationalModel":41,"timePerspective":41,"maskingInfo":46},"RANDOMIZED","PARALLEL","DIAGNOSTIC",{"masking":47,"maskingDescription":41,"whoMasked":41},"NONE","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.\n\nPatients 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.\n\nThe 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.",[50,56],{"label":51,"type":52,"description":53,"interventionNames":54},"3 months follow-up","EXPERIMENTAL","Patients will be follow-up every 3 months after gastrectomy.",[55],"Diagnostic Test: Computed tomography, Chest X-ray, and blood test",{"label":57,"type":58,"description":59,"interventionNames":60},"6 months follow-up","ACTIVE_COMPARATOR","Patients will be follow-up every 6 months after gastrectomy.",[55],[62],{"type":63,"name":64,"description":65,"armGroupLabels":66,"otherNames":41},"DIAGNOSTIC_TEST","Computed tomography, Chest X-ray, and blood test","CT will be performed every 3 months after gastrectomy in the 3-months follow-up group. CT will be performed every 6 months after gastrectomy in the 6 months follow-up group.",[51,57],[68],{"name":69,"affiliation":5,"role":70},"Keun Won Ryu, MD PhD","PRINCIPAL_INVESTIGATOR",[72],{"name":73,"role":74,"phone":75,"phoneExt":41,"email":76},"Bang Wool Eom, MD PhD","CONTACT","82-31-920-1689","kneeling79@ncc.re.kr",[78,104,118,130,144,158,169,183,197,211,227,240,253,264,281,292],{"facility":5,"status":79,"city":80,"state":81,"zip":82,"country":83,"countryCode":41,"cosmosGeoPoint":84,"geoPoint":89,"contacts":90},"RECRUITING","Goyang-si","Gyeonggi-do","10408","South Korea",{"type":85,"coordinates":86},"Point",[87,88],126.835,37.65639,{"lat":88,"lon":87},[91,95,97,98,101,103],{"name":92,"role":74,"phone":93,"phoneExt":41,"email":94},"Keun Won Ryu, PhD","82-31-920-1628","docryu@korea.com",{"name":96,"role":74,"phone":75,"phoneExt":41,"email":76},"Bang Wool Eom, PhD",{"name":92,"role":70,"phone":41,"phoneExt":41,"email":41},{"name":99,"role":100,"phone":41,"phoneExt":41,"email":41},"Young-Woo Kim, PhD","SUB_INVESTIGATOR",{"name":102,"role":100,"phone":41,"phoneExt":41,"email":41},"Hong Man Yoon, MS",{"name":96,"role":100,"phone":41,"phoneExt":41,"email":41},{"facility":105,"status":79,"city":106,"state":41,"zip":41,"country":83,"countryCode":41,"cosmosGeoPoint":107,"geoPoint":111,"contacts":112},"Dongnam Institute of Radiological and Medical Sciences","Busan",{"type":85,"coordinates":108},[109,110],129.03004,35.10168,{"lat":110,"lon":109},[113,117],{"name":114,"role":74,"phone":115,"phoneExt":41,"email":116},"Jae Seok Min","82-10-9567-9488","mdoogy@naver.com",{"name":114,"role":70,"phone":41,"phoneExt":41,"email":41},{"facility":119,"status":120,"city":106,"state":41,"zip":41,"country":83,"countryCode":41,"cosmosGeoPoint":121,"geoPoint":123,"contacts":124},"Kosin University Gospel Hospital","NOT_YET_RECRUITING",{"type":85,"coordinates":122},[109,110],{"lat":110,"lon":109},[125,129],{"name":126,"role":74,"phone":127,"phoneExt":41,"email":128},"Kyung Won Seo","82-10-4596-0773","hahachristi@gmail.com",{"name":126,"role":70,"phone":41,"phoneExt":41,"email":41},{"facility":131,"status":79,"city":132,"state":41,"zip":41,"country":83,"countryCode":41,"cosmosGeoPoint":133,"geoPoint":137,"contacts":138},"Gyeongsang National University Changwon Hospital","Changwon",{"type":85,"coordinates":134},[135,136],128.68111,35.22806,{"lat":136,"lon":135},[139,143],{"name":140,"role":74,"phone":141,"phoneExt":41,"email":142},"Sang-Ho Jeong","82-55-214-3771","jshgnu@gmail.com",{"name":140,"role":70,"phone":41,"phoneExt":41,"email":41},{"facility":145,"status":79,"city":146,"state":41,"zip":41,"country":83,"countryCode":41,"cosmosGeoPoint":147,"geoPoint":151,"contacts":152},"Keimyung University Dongsan Hospital","Daegu",{"type":85,"coordinates":148},[149,150],128.59111,35.87028,{"lat":150,"lon":149},[153,157],{"name":154,"role":74,"phone":155,"phoneExt":41,"email":156},"Seung Wan Ryu","82-10-3522-9659","koreagsman@gmail.com",{"name":154,"role":70,"phone":41,"phoneExt":41,"email":41},{"facility":159,"status":79,"city":146,"state":41,"zip":41,"country":83,"countryCode":41,"cosmosGeoPoint":160,"geoPoint":162,"contacts":163},"Kyungpook National University Chilgok Hospital",{"type":85,"coordinates":161},[149,150],{"lat":150,"lon":149},[164,168],{"name":165,"role":74,"phone":166,"phoneExt":41,"email":167},"Oh Kyoung Kwon","82-10-4173-3324","quack72@naver.com",{"name":165,"role":70,"phone":41,"phoneExt":41,"email":41},{"facility":170,"status":79,"city":171,"state":41,"zip":41,"country":83,"countryCode":41,"cosmosGeoPoint":172,"geoPoint":176,"contacts":177},"Chonnam National University Hwasun Hospital","Hwasun",{"type":85,"coordinates":173},[174,175],126.98746,35.06125,{"lat":175,"lon":174},[178,182],{"name":179,"role":74,"phone":180,"phoneExt":41,"email":181},"Oh Jeong","82-61-379-7648","surgeonjeong@gmail.com",{"name":179,"role":70,"phone":41,"phoneExt":41,"email":41},{"facility":184,"status":79,"city":185,"state":41,"zip":41,"country":83,"countryCode":41,"cosmosGeoPoint":186,"geoPoint":190,"contacts":191},"Gyeongsang National University Hospital","Jinju",{"type":85,"coordinates":187},[188,189],128.08472,35.19278,{"lat":189,"lon":188},[192,196],{"name":193,"role":74,"phone":194,"phoneExt":41,"email":195},"Ji-Ho Park","82-10-9335-0510","goodgsdr@gmail.com",{"name":193,"role":70,"phone":41,"phoneExt":41,"email":41},{"facility":198,"status":79,"city":199,"state":41,"zip":41,"country":83,"countryCode":41,"cosmosGeoPoint":200,"geoPoint":204,"contacts":205},"CHA Bundang Medical Center","Seongnam",{"type":85,"coordinates":201},[202,203],127.7548,36.4052,{"lat":203,"lon":202},[206,210],{"name":207,"role":74,"phone":208,"phoneExt":41,"email":209},"Su Mi Kim","82-10-9933-5261","soma21c@gmail.com",{"name":207,"role":70,"phone":41,"phoneExt":41,"email":41},{"facility":212,"status":79,"city":213,"state":41,"zip":41,"country":83,"countryCode":41,"cosmosGeoPoint":214,"geoPoint":218,"contacts":219},"Asan Medical Center","Seoul",{"type":85,"coordinates":215},[216,217],126.9784,37.566,{"lat":217,"lon":216},[220,224,225],{"name":221,"role":74,"phone":222,"phoneExt":41,"email":223},"Moon-Won Yoo","82-10-2965-7588","medigang@hanmail.net",{"name":221,"role":70,"phone":41,"phoneExt":41,"email":41},{"name":226,"role":100,"phone":41,"phoneExt":41,"email":41},"Min-Hee Ryu",{"facility":228,"status":79,"city":213,"state":41,"zip":41,"country":83,"countryCode":41,"cosmosGeoPoint":229,"geoPoint":231,"contacts":232},"Kangbuk Samsung Hospital",{"type":85,"coordinates":230},[216,217],{"lat":217,"lon":216},[233,237,238],{"name":234,"role":74,"phone":235,"phoneExt":41,"email":236},"Chang Hak Yoo, PhD","82-10-9417-9868","chyoo63@naver.com",{"name":234,"role":70,"phone":41,"phoneExt":41,"email":41},{"name":239,"role":100,"phone":41,"phoneExt":41,"email":41},"Dong-Hoe Koo, PhD",{"facility":241,"status":79,"city":213,"state":41,"zip":41,"country":83,"countryCode":41,"cosmosGeoPoint":242,"geoPoint":244,"contacts":245},"Samsung Medical Center",{"type":85,"coordinates":243},[216,217],{"lat":217,"lon":216},[246,250,251],{"name":247,"role":74,"phone":248,"phoneExt":41,"email":249},"Ji Yeoung An, PhD","82-10-2717-4610","jar319.an@samsung.com",{"name":247,"role":70,"phone":41,"phoneExt":41,"email":41},{"name":252,"role":100,"phone":41,"phoneExt":41,"email":41},"Sung Eun Oh",{"facility":254,"status":79,"city":213,"state":41,"zip":41,"country":83,"countryCode":41,"cosmosGeoPoint":255,"geoPoint":257,"contacts":258},"Seoul National University Hospital",{"type":85,"coordinates":256},[216,217],{"lat":217,"lon":216},[259,263],{"name":260,"role":74,"phone":261,"phoneExt":41,"email":262},"Hyuk-Joon Lee, PhD","82-2-2072-1957","appe98@snu.ac.kr",{"name":260,"role":70,"phone":41,"phoneExt":41,"email":41},{"facility":265,"status":79,"city":213,"state":41,"zip":41,"country":83,"countryCode":41,"cosmosGeoPoint":266,"geoPoint":268,"contacts":269},"Seoul St. Mary's Hospital",{"type":85,"coordinates":267},[216,217],{"lat":217,"lon":216},[270,274,275,277,279],{"name":271,"role":74,"phone":272,"phoneExt":41,"email":273},"Han Hong Lee, PhD","82-10-4326-6039","painkiller9@catholic.ac.kr",{"name":271,"role":70,"phone":41,"phoneExt":41,"email":41},{"name":276,"role":100,"phone":41,"phoneExt":41,"email":41},"Kyo Young Song, PhD",{"name":278,"role":100,"phone":41,"phoneExt":41,"email":41},"Ho Seok Seo",{"name":280,"role":100,"phone":41,"phoneExt":41,"email":41},"Chul Hyo Jeon",{"facility":282,"status":79,"city":213,"state":41,"zip":41,"country":83,"countryCode":41,"cosmosGeoPoint":283,"geoPoint":285,"contacts":286},"Yonsei Univeristy College of Medicine",{"type":85,"coordinates":284},[216,217],{"lat":217,"lon":216},[287,291],{"name":288,"role":74,"phone":289,"phoneExt":41,"email":290},"Hyoung-Il Kim, PhD","82-10-2556-4986","CAIRUS@yuhs.ac",{"name":288,"role":70,"phone":41,"phoneExt":41,"email":41},{"facility":293,"status":79,"city":294,"state":41,"zip":41,"country":83,"countryCode":41,"cosmosGeoPoint":295,"geoPoint":299,"contacts":300},"Ajou University School of Medicine","Suwon",{"type":85,"coordinates":296},[297,298],127.00889,37.29111,{"lat":298,"lon":297},[301,305],{"name":302,"role":74,"phone":303,"phoneExt":41,"email":304},"Hoon Hur, PhD","82-31-219-4459","hhcmc75@naver.com",{"name":302,"role":70,"phone":41,"phoneExt":41,"email":41},{"type":70,"investigatorFullName":307,"investigatorTitle":308,"investigatorAffiliation":5,"oldNameTitle":41,"oldOrganization":41},"Keun Won Ryu","Principal Investigator",[310],{"name":311,"class":6},"Korea Health Industry Development Institute","100419332",false,"NCT04740346","Survival Rates and Quality of Life According to Follow-up Period After Gastrectomy for Gastric Cancer (STOFOLUP)","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)","Inclusion Criteria:\n\n* Patients aged 19 years or more\n* Patients who are diagnosed with pathological stage II or III gastric adenocarcinoma according to the AJCC 8th edition\n* Patients who can understand all information about the trial and decide for themselves whether to participate in this study\n\nExclusion Criteria:\n\n* Vulnerable patients such as pregnant and intellectual disability\n* Patients who cannot undergo CT owing to poor kidney function or severe adverse effects\n* Patients who are already in another study and cannot follow the schedule for this trial\n* Patients who are diagnosed with a cancer other than gastric cancer within five years before the gastrectomy\n* Patients being treated for a cancer other than gastric cancer","ALL","19 Years",{"count":321,"type":322},886,"ESTIMATED","INTERVENTIONAL",[325],"NA","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.",[328,329,330],"Gastric Cancer","Recurrence","Quality of Life","2021-10-26",{"date":333,"type":334},"2021-10-27","ACTUAL",{"date":336,"type":334},"2021-07-05",{"date":338,"type":322},"2026-06-30",{"name":5,"class":6},16]