Gastric CancerNCT04740346
Survival Rates and Quality of Life According to Follow-up Period After Gastrectomy for Gastric Cancer (STOFOLUP)
A study testing Computed tomography, Chest X-ray, and blood test in people with Gastric Cancer and Recurrence, run by National Cancer Center, Korea at 16 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Gastric Cancer, Recurrence, Quality of Life
- What is being tested?
- Computed tomography, Chest X-ray, and blood test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 886 participants
- Where
- 16 sitesSouth Korea
- Study dates
- 5 Jul 2021to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
South Korea16 sites, 16 recruiting
- Recruiting
Dongnam Institute of Radiological and Medical Sciences
Busan
Jae Seok Min, 82-10-9567-9488, mdoogy@naver.com
Jae Seok Min
- Not yet recruiting
Kosin University Gospel Hospital
Busan
Kyung Won Seo, 82-10-4596-0773, hahachristi@gmail.com
Kyung Won Seo
- Recruiting
Gyeongsang National University Changwon Hospital
Changwon
Sang-Ho Jeong, 82-55-214-3771, jshgnu@gmail.com
Sang-Ho Jeong
- Recruiting
Keimyung University Dongsan Hospital
Daegu
Seung Wan Ryu, 82-10-3522-9659, koreagsman@gmail.com
Seung Wan Ryu
- Recruiting
Kyungpook National University Chilgok Hospital
Daegu
Oh Kyoung Kwon, 82-10-4173-3324, quack72@naver.com
Oh Kyoung Kwon
- Recruiting
National Cancer Center, Korea
Goyang-si, Gyeonggi-do, 10408
Keun Won Ryu, PhD, 82-31-920-1628, docryu@korea.com
Bang Wool Eom, PhD, 82-31-920-1689, kneeling79@ncc.re.kr
- Recruiting
Chonnam National University Hwasun Hospital
Hwasun
Oh Jeong, 82-61-379-7648, surgeonjeong@gmail.com
Oh Jeong
- Recruiting
Gyeongsang National University Hospital
Jinju
Ji-Ho Park, 82-10-9335-0510, goodgsdr@gmail.com
Ji-Ho Park
- Recruiting
CHA Bundang Medical Center
Seongnam
Su Mi Kim, 82-10-9933-5261, soma21c@gmail.com
Su Mi Kim
- Recruiting
Asan Medical Center
Seoul
Moon-Won Yoo, 82-10-2965-7588, medigang@hanmail.net
Moon-Won Yoo
- Recruiting
Kangbuk Samsung Hospital
Seoul
Chang Hak Yoo, PhD, 82-10-9417-9868, chyoo63@naver.com
Chang Hak Yoo, PhD
- Recruiting
Samsung Medical Center
Seoul
Ji Yeoung An, PhD, 82-10-2717-4610, jar319.an@samsung.com
Ji Yeoung An, PhD
- Recruiting
Seoul National University Hospital
Seoul
Hyuk-Joon Lee, PhD, 82-2-2072-1957, appe98@snu.ac.kr
Hyuk-Joon Lee, PhD
- Recruiting
Seoul St. Mary's Hospital
Seoul
Han Hong Lee, PhD, 82-10-4326-6039, painkiller9@catholic.ac.kr
Han Hong Lee, PhD
- Recruiting
Yonsei Univeristy College of Medicine
Seoul
Hyoung-Il Kim, PhD, 82-10-2556-4986, CAIRUS@yuhs.ac
Hyoung-Il Kim, PhD
- Recruiting
Ajou University School of Medicine
Suwon
Hoon Hur, PhD, 82-31-219-4459, hhcmc75@naver.com
Hoon Hur, PhD
About this study
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)
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.
Read the 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.
- Conditions
- Gastric Cancer, Recurrence, Quality of Life
- Being tested
- Computed tomography, Chest X-ray, and blood test
- Medical subject headings
- Stomach Neoplasms, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computed tomography, Chest X-ray, and blood testDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 3 months follow-up | Experimental | Patients will be follow-up every 3 months after gastrectomy. Receives: Diagnostic Test: Computed tomography, Chest X-ray, and blood test |
| 6 months follow-up | Active comparator | Patients will be follow-up every 6 months after gastrectomy. Receives: Diagnostic Test: Computed tomography, Chest X-ray, and blood test |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year overall survival
Death from any cause is defined as an event.
Measured: 3 years after surgery
Secondary outcomes (9)
3-year recurrence-free survival rate
Death from any cause and gastric cancer recurrence are an event.
Measured: 3 years after surgery
3-year gastric cancer specific survival rate
Death from gastric cancer is the only event.
Measured: 3 years after surgery
3-year post-recurrence survival rate
from recurrence detection date to last follow-up date (or death)
Measured: 3 years after surgery
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.
Measured: 3 years after surgery
Summary score of EORTC QLQ C30
EORTC QLQ C30 consists of 15 domains with 30 questions for quality of life of cancer patients. The 15 domains consist of five functional scales (physical, role, cognitive, emotional, and social functioning), a global QOL scale, three symptom scales (fatigue, nausea and vomiting, and pain), and six single items (appetite loss, diarrhea, dyspnea, constipation, insomnia, financial impact).
We will calculate the EORTC QLQ C30 summary score of each group and compare them between the two groups. The summary score is defined as the mean of 13 domains (excluding global QOL scale and financial impact). The minimum and maximum values are 0 and 100, and higher scores mean a better quality of life.
Measured: 3 years after surgery
Summary score of EORTC QLQ STO22
EORTC QLQ STO22 consists of 9 domains with 22 questions for stomach cancer patients' symptoms. The 9 domains consist of five symptom scales (dysphagia, pain, reflux symptom, eating restriction, anxiety), four single items (having a dry mouth, taste, body image, and hair loss).
We will calculate the EORTC QLQ STO22 summary score of each group and compare them between the two groups. The summary score is defined as the mean of 9 domains. The minimum and maximum values are 0 and 100, and higher scores mean a better quality of life.
Measured: 3 years after surgery
Difference of body weight (kg)
Difference of body weight between preoperative and postoperative 3 year values
Measured: 3 years after surgery
Incidence of iron deficiency anemia
Incidence of iron deficiency anemia for the 3 year follow-up after gastrectomy
Measured: 3 years after surgery
Incidence of vitamin B12 deficiency
Incidence of vitamin B12 deficiency for the 3 year follow-up after gastrectomy
Measured: 3 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2021
- Study start5 Jul 2021
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 886 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Center, Korea
- Sponsor type
- Other government
- Collaborators
- Korea Health Industry Development Institute
- Responsible party
- Principal investigator, Keun Won Ryu, National Cancer Center, Korea
- Investigators
- Keun Won Ryu, MD PhD, Principal investigator, National Cancer Center, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04740346
- Sponsor's protocol ID
- HC20C0155
- Status last verified
- Oct 2021
- First submitted
- 1 Feb 2021
- Last updated
- 27 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34880028
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04740346
- Acronym / sponsor ID
- HC20C0155
- Conditions
- Gastric Cancer, Recurrence, Quality of Life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 886 participants (estimated)
- Lead sponsor
- National Cancer Center, KoreaOther government
- Collaborators
- Korea Health Industry Development Institute
- Study start
- 5 Jul 2021 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 5 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3 months follow-up | Experimental | Diagnostic Test: Computed tomography, Chest X-ray, and blood testPatients will be follow-up every 3 months after gastrectomy. |
| 6 months follow-up | Active comparator | Diagnostic Test: Computed tomography, Chest X-ray, and blood testPatients will be follow-up every 6 months after gastrectomy. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computed tomography, Chest X-ray, and blood 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. | Diagnostic test | 3 months follow-up, 6 months follow-up |
Primary outcome
3-year overall survival
Time frame: 3 years after surgery
Death from any cause is defined as an event.
9 secondary outcomes
3-year recurrence-free survival rate
Time frame: 3 years after surgery
3-year gastric cancer specific survival rate
Time frame: 3 years after surgery
3-year post-recurrence survival rate
Time frame: 3 years after surgery
Summary score of KOQUSS-40 questionnaire
Time frame: 3 years after surgery
Summary score of EORTC QLQ C30
Time frame: 3 years after surgery
Summary score of EORTC QLQ STO22
Time frame: 3 years after surgery
Difference of body weight (kg)
Time frame: 3 years after surgery
Incidence of iron deficiency anemia
Time frame: 3 years after surgery
Incidence of vitamin B12 deficiency
Time frame: 3 years after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2021.
- Derived from this study: PubMed 34880028Eom 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Keun Won Ryu, MD PhD principal investigator
National Cancer Center, Korea
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computed tomography, Chest X-ray, and blood test in people with Gastric Cancer and Recurrence, run by National Cancer Center, Korea at 16 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bang Wool Eom, MD PhD (82-31-920-1689, kneeling79@ncc.re.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-year overall survival (time frame: 3 years after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04740346, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2021.