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)
1 other identifier
interventional
886
1 country
16
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable gastric-cancer
Started Jul 2021
Longer than P75 for not_applicable gastric-cancer
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 1, 2021
CompletedFirst Posted
Study publicly available on registry
February 5, 2021
CompletedStudy Start
First participant enrolled
July 5, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2026
October 27, 2021
October 1, 2021
5 years
February 1, 2021
October 26, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
3-year overall survival
Death from any cause is defined as an event.
3 years after surgery
Secondary Outcomes (9)
3-year recurrence-free survival rate
3 years after surgery
3-year gastric cancer specific survival rate
3 years after surgery
3-year post-recurrence survival rate
3 years after surgery
Summary score of KOQUSS-40 questionnaire
3 years after surgery
Summary score of EORTC QLQ C30
3 years after surgery
- +4 more secondary outcomes
Study Arms (2)
3 months follow-up
EXPERIMENTALPatients will be follow-up every 3 months after gastrectomy.
6 months follow-up
ACTIVE COMPARATORPatients will be follow-up every 6 months after gastrectomy.
Interventions
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
You may qualify if:
- Patients aged 19 years or more
- 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
You may not qualify if:
- Vulnerable patients such as pregnant and intellectual disability
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
National Cancer Center, Korea
Goyang-si, Gyeonggi-do, 10408, 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
Related Publications (1)
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.
PMID: 34880028DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Keun Won Ryu, MD PhD
National Cancer Center, Korea
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 1, 2021
First Posted
February 5, 2021
Study Start
July 5, 2021
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
June 30, 2026
Last Updated
October 27, 2021
Record last verified: 2021-10
Data Sharing
- IPD Sharing
- Will not share