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

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

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.

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.

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.

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.

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.

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.

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

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.