Survival Rates and Quality of Life According to Follow-up Period After Gastrectomy for Gastric Cancer (STOFOLUP)
NCT ID: NCT04740346
Last Updated: 2021-10-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
886 participants
INTERVENTIONAL
2021-07-05
2026-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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3 months follow-up
Patients will be follow-up every 3 months after gastrectomy.
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.
6 months follow-up
Patients will be follow-up every 6 months after gastrectomy.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
19 Years
ALL
No
Sponsors
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Korea Health Industry Development Institute
OTHER_GOV
National Cancer Center, Korea
OTHER_GOV
Responsible Party
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Keun Won Ryu
Principal Investigator
Principal Investigators
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Keun Won Ryu, MD PhD
Role: PRINCIPAL_INVESTIGATOR
National Cancer Center, Korea
Locations
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National Cancer Center, Korea
Goyang-si, Gyeonggi-do, South Korea
Dongnam Institute of Radiological and Medical Sciences
Busan, , South Korea
Kosin University Gospel Hospital
Busan, , South Korea
Gyeongsang National University Changwon Hospital
Changwon, , South Korea
Keimyung University Dongsan Hospital
Daegu, , South Korea
Kyungpook National University Chilgok Hospital
Daegu, , South Korea
Chonnam National University Hwasun Hospital
Hwasun, , South Korea
Gyeongsang National University Hospital
Jinju, , South Korea
CHA Bundang Medical Center
Seongnam, , South Korea
Asan Medical Center
Seoul, , South Korea
Kangbuk Samsung Hospital
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Seoul St. Mary's Hospital
Seoul, , South Korea
Yonsei Univeristy College of Medicine
Seoul, , South Korea
Ajou University School of Medicine
Suwon, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Keun Won Ryu, PhD
Role: primary
Bang Wool Eom, PhD
Role: backup
Jae Seok Min
Role: primary
Kyung Won Seo
Role: primary
Sang-Ho Jeong
Role: primary
Seung Wan Ryu
Role: primary
Oh Kyoung Kwon
Role: primary
Oh Jeong
Role: primary
Ji-Ho Park
Role: primary
Su Mi Kim
Role: primary
Moon-Won Yoo
Role: primary
Chang Hak Yoo, PhD
Role: primary
Ji Yeoung An, PhD
Role: primary
Hyuk-Joon Lee, PhD
Role: primary
Han Hong Lee, PhD
Role: primary
Hyoung-Il Kim, PhD
Role: primary
Hoon Hur, PhD
Role: primary
References
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Eom BW, Koo DH, An JY, Lee HH, Kim HI, Hur H, Yoo MW, Ryu MH, Lee HJ, Kim SM, Park JH, Min JS, Seo KW, Jeong SH, Jeong O, Kwon OK, Ryu SW, Yoo CH, Bae JM, Ryu KW. 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. BMJ Open. 2021 Dec 8;11(12):e056187. doi: 10.1136/bmjopen-2021-056187.
Other Identifiers
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HC20C0155
Identifier Type: -
Identifier Source: org_study_id