Survival Rates and Quality of Life According to Follow-up Period After Gastrectomy for Gastric Cancer (STOFOLUP)

Quality of Life Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04740346
• Other study ID #: HC20C0155
• Status: Recruiting
• Phase: N/A
• Start date: July 5, 2021
• Est. completion date: June 30, 2026

Study information

• Verified date: October 2021
• Source: National Cancer Center, Korea
• Contact: Bang Wool Eom, MD PhD
• Phone: 82-31-920-1689
• Email: kneeling79[@]ncc.re.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 886
• Est. completion date: June 30, 2026
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gastric Cancer
• Quality of Life
• Recurrence
• Stomach Neoplasms

Intervention

Diagnostic Test:
• Computed tomography, Chest X-ray, and blood 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.

Locations

Country	Name	City	State
Korea, Republic of	Dongnam Institute of Radiological and Medical Sciences	Busan
Korea, Republic of	Kosin University Gospel Hospital	Busan
Korea, Republic of	Gyeongsang National University Changwon Hospital	Changwon
Korea, Republic of	Keimyung University Dongsan Hospital	Daegu
Korea, Republic of	Kyungpook National University Chilgok Hospital	Daegu
Korea, Republic of	National Cancer Center, Korea	Goyang	Gyeonggi-do
Korea, Republic of	Chonnam National University Hwasun Hospital	Hwasun
Korea, Republic of	Gyeongsang National University Hospital	Jinju
Korea, Republic of	CHA Bundang Medical Center	Seongnam
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Kangbuk Samsung Hospital	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Seoul St. Mary's Hospital	Seoul
Korea, Republic of	Yonsei Univeristy College of Medicine	Seoul
Korea, Republic of	Ajou University School of Medicine	Suwon

Sponsors (2)

Lead Sponsor	Collaborator
National Cancer Center, Korea	Korea Health Industry Development Institute

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3-year overall survival	Death from any cause is defined as an event.	3 years after surgery
Secondary	3-year recurrence-free survival rate	Death from any cause and gastric cancer recurrence are an event.	3 years after surgery
Secondary	3-year gastric cancer specific survival rate	Death from gastric cancer is the only event.	3 years after surgery
Secondary	3-year post-recurrence survival rate	from recurrence detection date to last follow-up date (or death)	3 years after surgery
Secondary	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
Secondary	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
Secondary	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
Secondary	Difference of body weight (kg)	Difference of body weight between preoperative and postoperative 3 year values	3 years after surgery
Secondary	Incidence of iron deficiency anemia	Incidence of iron deficiency anemia for the 3 year follow-up after gastrectomy	3 years after surgery
Secondary	Incidence of vitamin B12 deficiency	Incidence of vitamin B12 deficiency for the 3 year follow-up after gastrectomy	3 years after surgery