onrandomized confirmatory study of laparoscopy assisted total gastrectomy and proximal gastrectomy with nodal dissection for clinical stage I gastric cancer (JCOG1401, cSt-I GC LATG PG sP3)
Phase 3
- Conditions
- gastric cancer
- Registration Number
- JPRN-UMIN000017155
- Lead Sponsor
- Japan Clinical Oncology Group (JCOG)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 245
Inclusion Criteria
Not provided
Exclusion Criteria
1) Synchronous or metachronous (within 5 years) malignancies except for carcinoma in situ or mucosal tumors curatively treated with local therapy. 2) Infectious disease with systemic therapy indicated. 3) Body temperature of 38 or more degrees Celsius. 4) Pregnancy, possible pregnancy, within 28 days after delivery or breast-feeding. 5) Severe psychiatric disease. 6) Continuous systemic steroid or immune-suppressive drug therapy. 7) Unstable angina pectoris, or history of myocardial infarction within six months. 8) Poorly controlled hypertension. 9) Poorly controlled diabetes mellitus in spite of continuous use of insulin. 10) Severe respiratory disease requiring continuous oxygen therapy.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of anastomotic leak
- Secondary Outcome Measures
Name Time Method Overall survival, relapse-free survival, proportion of LATG or LAPG completion, proportion of conversion to open surgery, adverse events, and short-term clinical outcomes