Comparing survival rates and quality of life after gastrectomy for gastric cancer
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 testing how long people with stage 2 or 3 gastric cancer live and how their quality of life changes after surgery, comparing those who are followed for 3 months versus 6 months.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 886 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | National Cancer Center, Korea Government |
| Locations | 16 sites (Goyang-si, Gyeonggi-do and 15 other locations) |
| Trial ID | NCT04740346 on ClinicalTrials.gov |
What this trial studies
This multi-center, prospective, randomized controlled study aims to compare survival rates and assess quality of life and nutritional status in patients who have undergone radical gastrectomy for stage 2 or 3 gastric cancer. Participants will be assigned to either a 3-month or 6-month follow-up group, with the hypothesis that survival rates will differ between these groups. The study will involve various examinations, including blood tests, X-rays, CT scans, and endoscopies, over a follow-up period of three years. The primary endpoint is the overall survival rate at three years, while secondary endpoints include disease-free survival, gastric cancer-specific survival, quality of life, and nutritional parameters.
Who should consider this trial
Good fit: Ideal candidates are patients aged 19 years or older diagnosed with stage II or III gastric adenocarcinoma who can provide informed consent.
Not a fit: Patients with other cancers, severe kidney issues, or those who are pregnant or intellectually disabled may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into optimal follow-up periods that enhance survival and quality of life for gastric cancer patients post-gastrectomy.
How similar studies have performed: Previous studies have indicated potential differences in survival rates based on follow-up periods, suggesting that this approach may yield valuable insights.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Goyang-si, Gyeonggi-do and 15 other locations
- National Cancer Center, Korea — Goyang-si, Gyeonggi-do, South Korea (Recruiting)
- Dongnam Institute of Radiological and Medical Sciences — Busan, South Korea (Recruiting)
- Kosin University Gospel Hospital — Busan, South Korea (Not_yet_recruiting)
- Gyeongsang National University Changwon Hospital — Changwon, South Korea (Recruiting)
- Keimyung University Dongsan Hospital — Daegu, South Korea (Recruiting)
- Kyungpook National University Chilgok Hospital — Daegu, South Korea (Recruiting)
- Chonnam National University Hwasun Hospital — Hwasun, South Korea (Recruiting)
- Gyeongsang National University Hospital — Jinju, South Korea (Recruiting)
- CHA Bundang Medical Center — Seongnam, South Korea (Recruiting)
- Asan Medical Center — Seoul, South Korea (Recruiting)
- Kangbuk Samsung Hospital — Seoul, South Korea (Recruiting)
- Samsung Medical Center — Seoul, South Korea (Recruiting)
- Seoul National University Hospital — Seoul, South Korea (Recruiting)
- Seoul St. Mary's Hospital — Seoul, South Korea (Recruiting)
- Yonsei Univeristy College of Medicine — Seoul, South Korea (Recruiting)
- Ajou University School of Medicine — Suwon, South Korea (Recruiting)
Study contacts
- Principal investigator: Keun Won Ryu, MD PhD — National Cancer Center, Korea
- Study coordinator: Bang Wool Eom, MD PhD
- Email: kneeling79@ncc.re.kr
- Phone: 82-31-920-1689
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.