Cited 4 times in
Prospective multicentre randomised clinical trial comparing survival rates, quality of life and nutritional status between advanced gastric cancer patients with different follow-up intensities: study protocol for the STOFOLUP trial
DC Field | Value | Language |
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dc.contributor.author | 김형일 | - |
dc.date.accessioned | 2022-05-09T16:47:55Z | - |
dc.date.available | 2022-05-09T16:47:55Z | - |
dc.date.issued | 2021-12 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/188202 | - |
dc.description.abstract | Introduction: Patients who underwent curative gastrectomy for gastric cancer are regularly followed-up for the early detection of recurrence and postoperative symptom management. However, there is a lack of evidence with regard to proper surveillance intervals and diagnostic tools. This study aims to evaluate whether frequent surveillance tests have a survival benefit or improve the quality of life in patients who underwent curative resection for advanced gastric cancer. Methods and analysis: The STOFOLUP trial is an investigator-initiated, parallel-assigned, multicentre randomised controlled trial involving 16 hospitals in the Republic of Korea. Patients (n=886) diagnosed with pathological stage II or III gastric adenocarcinoma will be randomised to either the 3-month or the 6-month group at a 1:1 ratio, stratified by trial site and tumour stage. Patients allocated to the 3-month group will undergo an abdominal CT scan every 3 months postoperatively and those allocated to the 6-month group will undergo CT every 6 months. The primary endpoint is 3-year overall survival and the secondary endpoints are quality of life, as assessed using KOrean QUality of life in Stomach cancer patients Study group-40, the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 and the stomach cancer-specific module (STO22), and nutritional outcomes. Other survival data including data concerning 3-year disease-free survival, recurrence-free survival, gastric cancer-specific survival and postrecurrence survival will also be estimated. The first patient was enrolled on July 2021 and active patient enrolment is currently underway. Ethics and dissemination: This study has been approved by the Institutional Review Board of eight of the participating hospitals (NCC 2021-0085, KBSMC2021-01-059, SMC 2021-01-140, KC21OEDE0082, 4-2021-0281, AJIRB-MED-INT-20-608, 2021-0515 and H-2102-093-1198). This study will be disseminated through peer-reviewed publications, national or international conferences. Trial registration number: NCT04740346. | - |
dc.description.statementOfResponsibility | open | - |
dc.language | English | - |
dc.publisher | BMJ Publishing Group Ltd | - |
dc.relation.isPartOf | BMJ OPEN | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.subject.MESH | Follow-Up Studies | - |
dc.subject.MESH | Humans | - |
dc.subject.MESH | Multicenter Studies as Topic | - |
dc.subject.MESH | Nutritional Status | - |
dc.subject.MESH | Prospective Studies | - |
dc.subject.MESH | Quality of Life | - |
dc.subject.MESH | Randomized Controlled Trials as Topic | - |
dc.subject.MESH | Stomach Neoplasms* / pathology | - |
dc.subject.MESH | Survival Rate | - |
dc.title | Prospective multicentre randomised clinical trial comparing survival rates, quality of life and nutritional status between advanced gastric cancer patients with different follow-up intensities: study protocol for the STOFOLUP trial | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine (의과대학) | - |
dc.contributor.department | Dept. of Surgery (외과학교실) | - |
dc.contributor.googleauthor | Bang Wool Eom | - |
dc.contributor.googleauthor | Dong-Hoe Koo | - |
dc.contributor.googleauthor | Ji Yeong An | - |
dc.contributor.googleauthor | Han Hong Lee | - |
dc.contributor.googleauthor | Hyoung-Il Kim | - |
dc.contributor.googleauthor | Hoon Hur | - |
dc.contributor.googleauthor | Moon-Won Yoo | - |
dc.contributor.googleauthor | Min-Hee Ryu | - |
dc.contributor.googleauthor | Hyuk-Joon Lee | - |
dc.contributor.googleauthor | Su Mi Kim | - |
dc.contributor.googleauthor | Ji-Ho Park | - |
dc.contributor.googleauthor | Jae Seok Min | - |
dc.contributor.googleauthor | Kyung Won Seo | - |
dc.contributor.googleauthor | Sang-Ho Jeong | - |
dc.contributor.googleauthor | Oh Jeong | - |
dc.contributor.googleauthor | Oh Kyoung Kwon | - |
dc.contributor.googleauthor | Seung Wan Ryu | - |
dc.contributor.googleauthor | Chang Hak Yoo | - |
dc.contributor.googleauthor | Jae Moon Bae | - |
dc.contributor.googleauthor | Keun Won Ryu | - |
dc.identifier.doi | 10.1136/bmjopen-2021-056187 | - |
dc.contributor.localId | A01154 | - |
dc.relation.journalcode | J00380 | - |
dc.identifier.eissn | 2044-6055 | - |
dc.identifier.pmid | 34880028 | - |
dc.subject.keyword | gastrointestinal tumours | - |
dc.subject.keyword | protocols & guidelines | - |
dc.subject.keyword | surgery | - |
dc.contributor.alternativeName | Kim, Hyoung Il | - |
dc.contributor.affiliatedAuthor | 김형일 | - |
dc.citation.volume | 11 | - |
dc.citation.number | 12 | - |
dc.citation.startPage | e056187 | - |
dc.identifier.bibliographicCitation | BMJ OPEN, Vol.11(12) : e056187, 2021-12 | - |
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