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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

 Bang Wool Eom  ;  Dong-Hoe Koo  ;  Ji Yeong An  ;  Han Hong Lee  ;  Hyoung-Il Kim  ;  Hoon Hur  ;  Moon-Won Yoo  ;  Min-Hee Ryu  ;  Hyuk-Joon Lee  ;  Su Mi Kim  ;  Ji-Ho Park  ;  Jae Seok Min  ;  Kyung Won Seo  ;  Sang-Ho Jeong  ;  Oh Jeong  ;  Oh Kyoung Kwon  ;  Seung Wan Ryu  ;  Chang Hak Yoo  ;  Jae Moon Bae  ;  Keun Won Ryu 
 BMJ OPEN, Vol.11(12) : e056187, 2021-12 
Journal Title
Issue Date
Follow-Up Studies ; Humans ; Multicenter Studies as Topic ; Nutritional Status ; Prospective Studies ; Quality of Life ; Randomized Controlled Trials as Topic ; Stomach Neoplasms* / pathology ; Survival Rate
gastrointestinal tumours ; protocols & guidelines ; surgery
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.
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1. College of Medicine (의과대학) > Dept. of Surgery (외과학교실) > 1. Journal Papers
Yonsei Authors
Kim, Hyoung Il(김형일) ORCID logo https://orcid.org/0000-0002-6134-4523
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