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

October 26, 2021 updated by: Keun Won Ryu, National Cancer Center, Korea

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
886

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Korea, Republic of
      • Busan, Korea, Republic of
        • Not yet recruiting
        • Kosin University Gospel Hospital
        • Contact:
        • Principal Investigator:
          • Kyung Won Seo
      • Busan, Korea, Republic of
        • Recruiting
        • Dongnam Institute of Radiological and Medical Sciences
        • Contact:
        • Principal Investigator:
          • Jae Seok Min
      • Changwon, Korea, Republic of
        • Recruiting
        • Gyeongsang National University Changwon Hospital
        • Contact:
        • Principal Investigator:
          • Sang-Ho Jeong
      • Daegu, Korea, Republic of
        • Recruiting
        • Kyungpook National University Chilgok Hospital
        • Contact:
        • Principal Investigator:
          • Oh Kyoung Kwon
      • Daegu, Korea, Republic of
        • Recruiting
        • Keimyung University Dongsan Hospital
        • Contact:
        • Principal Investigator:
          • Seung Wan Ryu
      • Hwasun, Korea, Republic of
        • Recruiting
        • Chonnam National University Hwasun Hospital
        • Contact:
        • Principal Investigator:
          • Oh Jeong
      • Jinju, Korea, Republic of
        • Recruiting
        • GyeongSang National University Hospital
        • Contact:
        • Principal Investigator:
          • Ji-Ho Park
      • Seongnam, Korea, Republic of
        • Recruiting
        • CHA Bundang Medical Center
        • Contact:
        • Principal Investigator:
          • Su Mi Kim
      • Seoul, Korea, Republic of
        • Recruiting
        • Asan Medical Center
        • Contact:
        • Principal Investigator:
          • Moon-Won Yoo
        • Sub-Investigator:
          • Min-Hee Ryu
      • Seoul, Korea, Republic of
        • Recruiting
        • Seoul National University Hospital
        • Contact:
        • Principal Investigator:
          • Hyuk-Joon Lee, PhD
      • Seoul, Korea, Republic of
        • Recruiting
        • Samsung Medical Center
        • Contact:
        • Principal Investigator:
          • Ji Yeoung An, PhD
        • Sub-Investigator:
          • Sung Eun Oh
      • Seoul, Korea, Republic of
        • Recruiting
        • Seoul St. Mary's Hospital
        • Contact:
        • Principal Investigator:
          • Han Hong Lee, PhD
        • Sub-Investigator:
          • Kyo Young Song, PhD
        • Sub-Investigator:
          • Ho Seok Seo
        • Sub-Investigator:
          • Chul Hyo Jeon
      • Seoul, Korea, Republic of
        • Recruiting
        • Kangbuk Samsung Hospital
        • Contact:
        • Principal Investigator:
          • Chang Hak Yoo, PhD
        • Sub-Investigator:
          • Dong-Hoe Koo, PhD
      • Seoul, Korea, Republic of
        • Recruiting
        • Yonsei Univeristy College of Medicine
        • Contact:
          • Hyoung-Il Kim, PhD
          • Phone Number: 82-10-2556-4986
          • Email: CAIRUS@yuhs.ac
        • Principal Investigator:
          • Hyoung-Il Kim, PhD
      • Suwon, Korea, Republic of
        • Recruiting
        • Ajou University School of Medicine
        • Contact:
        • Principal Investigator:
          • Hoon Hur, PhD
    • Gyeonggi-do
      • Goyang, Gyeonggi-do, Korea, Republic of, 10408
        • Recruiting
        • National Cancer Center, Korea
        • Contact:
        • Contact:
        • Principal Investigator:
          • Keun Won Ryu, PhD
        • Sub-Investigator:
          • Young-Woo Kim, PhD
        • Sub-Investigator:
          • Hong Man Yoon, MS
        • Sub-Investigator:
          • Bang Wool Eom, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 3 months follow-up
Patients will be follow-up every 3 months after gastrectomy.
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.
Active Comparator: 6 months follow-up
Patients will be follow-up every 6 months after gastrectomy.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
3-year overall survival
Time Frame: 3 years after surgery
Death from any cause is defined as an event.
3 years after surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
3-year recurrence-free survival rate
Time Frame: 3 years after surgery
Death from any cause and gastric cancer recurrence are an event.
3 years after surgery
3-year gastric cancer specific survival rate
Time Frame: 3 years after surgery
Death from gastric cancer is the only event.
3 years after surgery
3-year post-recurrence survival rate
Time Frame: 3 years after surgery
from recurrence detection date to last follow-up date (or death)
3 years after surgery
Summary score of KOQUSS-40 questionnaire
Time Frame: 3 years after surgery
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
Summary score of EORTC QLQ C30
Time Frame: 3 years after surgery

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
Summary score of EORTC QLQ STO22
Time Frame: 3 years after surgery

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
Difference of body weight (kg)
Time Frame: 3 years after surgery
Difference of body weight between preoperative and postoperative 3 year values
3 years after surgery
Incidence of iron deficiency anemia
Time Frame: 3 years after surgery
Incidence of iron deficiency anemia for the 3 year follow-up after gastrectomy
3 years after surgery
Incidence of vitamin B12 deficiency
Time Frame: 3 years after surgery
Incidence of vitamin B12 deficiency for the 3 year follow-up after gastrectomy
3 years after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Cancer Center, Korea

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Korea Health Industry Development Institute

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Keun Won Ryu, MD PhD, National Cancer Center, Korea

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 5, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2026

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 1, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 1, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 5, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 27, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 26, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HC20C0155

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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