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

National Cancer Center, Korea886 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

886

Conditions

Gastric Cancer Recurrence Quality of Life

Interventions

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.

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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

Locations (16)

National Cancer Center, Korea

Goyang-si, Gyeonggi-do, South Korea

RECRUITING

Dongnam Institute of Radiological and Medical Sciences

Busan, South Korea