Survival Rates and Quality of Life According to Follow-up Period After Gastrectomy for Gastric Cancer (STOFOLUP)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorNational Cancer Center, Korea
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Computed tomography, Chest X-ray, and blood test
Diagnostic testCT 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.
Treatment groups
886 Participants
are divided into 2 treatment groupsGroup A: 3 months follow-upExperimental treatment 1 intervention
Group B: 6 months follow-upActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
3-year overall survival
Death from any cause is defined as an event.
Time frame
3 years after surgerySecondary outcomes
1
3-year recurrence-free survival rate
Death from any cause and gastric cancer recurrence are an event.
Time frame
3 years after surgery2
3-year gastric cancer specific survival rate
Death from gastric cancer is the only event.
Time frame
3 years after surgery3
3-year post-recurrence survival rate
from recurrence detection date to last follow-up date (or death)
Time frame
3 years after surgery4
Summary score of KOQUSS-40 questionnaire
KOQUSS-40 consists of 8 domains with 40 questions for quality of life and post-gastrectomy symptoms. We will calculate the KOQUSS-40 summary score of each group and compare them between the two groups. The summary score is defined as the mean of eight symptom domains (Indigestion, dysphagia, reflux, dumping syndrome, bowel habit change, constipation, psychological factors, and worry about cancer). The minimum and maximum values are 0 and 100, and higher scores mean a better quality of life.
Time frame
3 years after surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
National Cancer Center, Korea
Lead sponsor
Korea Health Industry Development Institute
Collaborator
Source ClinicalTrials.gov