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| Name | Class |
|---|---|
| Korea Health Industry Development Institute | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3 months follow-up | Experimental | Patients will be follow-up every 3 months after gastrectomy. |
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| 6 months follow-up | Active Comparator | Patients will be follow-up every 6 months after gastrectomy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Computed tomography, Chest X-ray, and blood test | Diagnostic 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 3-year overall survival | Death from any cause is defined as an event. | 3 years after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 3-year recurrence-free survival rate | Death from any cause and gastric cancer recurrence are an event. | 3 years after surgery |
| 3-year gastric cancer specific survival rate | Death from gastric cancer is the only event. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bang Wool Eom, MD PhD | Contact | 82-31-920-1689 | kneeling79@ncc.re.kr |
| Name | Affiliation | Role |
|---|---|---|
| Keun Won Ryu, MD PhD | National Cancer Center, Korea | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Center, Korea | Recruiting | Goyang-si | Gyeonggi-do | 10408 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34880028 | Derived | 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. |
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| 3 years after surgery |
| 3-year post-recurrence survival rate | from recurrence detection date to last follow-up date (or death) | 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. | 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. | 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. | 3 years after surgery |
| Difference of body weight (kg) | Difference of body weight between preoperative and postoperative 3 year values | 3 years after surgery |
| Incidence of iron deficiency anemia | Incidence of iron deficiency anemia for the 3 year follow-up after gastrectomy | 3 years after surgery |
| Incidence of vitamin B12 deficiency | Incidence of vitamin B12 deficiency for the 3 year follow-up after gastrectomy | 3 years after surgery |
| Dongnam Institute of Radiological and Medical Sciences | Recruiting | Busan | South Korea |
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| Kosin University Gospel Hospital | Not yet recruiting | Busan | South Korea |
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| Gyeongsang National University Changwon Hospital | Recruiting | Changwon | South Korea |
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| Keimyung University Dongsan Hospital | Recruiting | Daegu | South Korea |
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| Kyungpook National University Chilgok Hospital | Recruiting | Daegu | South Korea |
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| Chonnam National University Hwasun Hospital | Recruiting | Hwasun | South Korea |
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| Gyeongsang National University Hospital | Recruiting | Jinju | South Korea |
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| CHA Bundang Medical Center | Recruiting | Seongnam | South Korea |
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| Asan Medical Center | Recruiting | Seoul | South Korea |
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| Kangbuk Samsung Hospital | Recruiting | Seoul | South Korea |
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| Samsung Medical Center | Recruiting | Seoul | South Korea |
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| Seoul National University Hospital | Recruiting | Seoul | South Korea |
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| Seoul St. Mary's Hospital | Recruiting | Seoul | South Korea |
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| Yonsei Univeristy College of Medicine | Recruiting | Seoul | South Korea |
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| Ajou University School of Medicine | Recruiting | Suwon | South Korea |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D014057 | Tomography, X-Ray Computed |
| D003952 | Diagnostic Imaging |
| D006403 | Hematologic Tests |
| ID | Term |
|---|---|
| D007090 | Image Interpretation, Computer-Assisted |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011856 | Radiographic Image Enhancement |
| D007089 | Image Enhancement |
| D010781 | Photography |
| D011859 | Radiography |
| D014056 | Tomography, X-Ray |
| D014054 | Tomography |
| D019411 | Clinical Laboratory Techniques |
| D008919 | Investigative Techniques |
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