Trials / Recruiting
RecruitingNCT04740346
Survival Rates and Quality of Life According to Follow-up Period After Gastrectomy for Gastric Cancer (STOFOLUP)
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)
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 886 (estimated)
- Sponsor
- National Cancer Center, Korea · Other Government
- Sex
- All
- Age
- 19 Years
- Healthy volunteers
- Not accepted
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.
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2021-07-05
- Primary completion
- 2026-06-30
- Completion
- 2026-06-30
- First posted
- 2021-02-05
- Last updated
- 2021-10-27
Locations
16 sites across 1 country: South Korea
Source: ClinicalTrials.gov record NCT04740346. Inclusion in this directory is not an endorsement.