Clinical trial NCT04740346: Survival Rates and Quality of Life According to Follow-up Period After Gastrectomy for Gastric Cancer (STOFOLUP)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gastric Cancer
Recurrence
Quality of Life
Lead sponsor: National Cancer Center, Korea
Sponsor class: OTHER_GOV
Collaborators: name: Korea Health Industry Development Institute
First posted: 2021-02-05
Enrollment: 886
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Detailed description: 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: 3-year overall survival
timeFrame: 3 years after surgery
Secondary outcomes:
measure: 3-year recurrence-free survival rate
timeFrame: 3 years after surgery
measure: 3-year gastric cancer specific survival rate
timeFrame: 3 years after surgery
measure: 3-year post-recurrence survival rate
timeFrame: 3 years after surgery
measure: Summary score of KOQUSS-40 questionnaire
timeFrame: 3 years after surgery
measure: Summary score of EORTC QLQ C30
timeFrame: 3 years after surgery
measure: Summary score of EORTC QLQ STO22
timeFrame: 3 years after surgery
measure: Difference of body weight (kg)
timeFrame: 3 years after surgery
measure: Incidence of iron deficiency anemia
timeFrame: 3 years after surgery
measure: Incidence of vitamin B12 deficiency
timeFrame: 3 years after surgery
Other outcomes:
Locations:
city: Goyang
country: Korea, Republic of
facility: National Cancer Center, Korea
state: Gyeonggi-do
city: Busan
country: Korea, Republic of
facility: Dongnam Institute of Radiological and Medical Sciences
city: Busan
country: Korea, Republic of
facility: Kosin University Gospel Hospital
city: Changwon
country: Korea, Republic of
facility: Gyeongsang National University Changwon Hospital
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Hospital
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Chilgok Hospital
city: Hwasun
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital
city: Jinju
country: Korea, Republic of
facility: Gyeongsang National University Hospital
city: Seongnam
country: Korea, Republic of
facility: CHA Bundang Medical Center
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul St. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Yonsei Univeristy College of Medicine
city: Suwon
country: Korea, Republic of
facility: Ajou University School of Medicine
Study officials:
affiliation: National Cancer Center, Korea
name: Keun Won Ryu, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.