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

  • STATUS
    Recruiting
  • End date
    Jun 30, 2026
  • participants needed
    886
  • sponsor
    National Cancer Center, Korea
Updated on 4 November 2021
gastrectomy
endoscopy
gastric adenocarcinoma
adenocarcinoma

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.

Details
Condition Relapse, Gastric Cancer, Gastric Carcinoma, quality-of-life, Stomach Cancer, gastric cancers, relapse/recurrence, Stomach Discomfort, Quality of life, Gastropathy
Treatment Computed tomography, Chest X-ray, and blood test
Clinical Study IdentifierNCT04740346
SponsorNational Cancer Center, Korea
Last Modified on4 November 2021

Eligibility

Yes No Not Sure

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
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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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