Randomized controlled phase III trial to evaluate omentum preserving gastrectomy for patients with advanced gastric cancer (JCOG1711, ROAD-GC)
Phase 3
Recruiting
- Conditions
- cT3(SS) or cT4a(SE) gastric cancer
- Registration Number
- JPRN-UMIN000036253
- Lead Sponsor
- Japan Clinical Oncology Group (JCOG)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 1050
Inclusion Criteria
Not provided
Exclusion Criteria
1) Synchronous or metachronous (within 5 years) malignancies. 2) Infectious disease requiring systemic treatment. 3) Body temperature of 38 degrees Celsius or higher. 4) During pregnancy, within 28 days of postparturition, or during lactation. 5) Severe mental disease. 6) Receiving continuous systemic corticosteroid or immunosuppressant treatment. 7)History of unstable angina pectoris within three weeks or myocardial infarction within six months before registration. 8)Poorly controlled valve disease, dilated or hypertrophic cardiomyopathy 9)HIV antibody positive 10)Interstitial pneumonia, pulmonary fibrosis, or severe emphysema based on chest CT
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Relapse-free survival
- Secondary Outcome Measures
Name Time Method Overall Survival, blood loss, operation time, adverse events