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

National Cancer Center (NCC)

Status: Enrolling

Conditions: Gastric Cancer; Quality of Life; Recurrence

Treatments: Diagnostic Test: Computed tomography, Chest X-ray, and blood test

Study type: Interventional

Funder types: Other

Identifiers

NCT04740346

HC20C0155

Details and patient eligibility

About

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.

Full 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.

Enrollment: 886 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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886 participants in 2 patient groups

3 months follow-up

Experimental group

Description:

Patients will be follow-up every 3 months after gastrectomy.

Treatment:

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

6 months follow-up

Active Comparator group

Description:

Patients will be follow-up every 6 months after gastrectomy.

Treatment:

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