JPRN-UMIN000017155
Completed
Phase 3
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) - Nonrandomized 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)
Japan Clinical Oncology Group (JCOG)0 sites245 target enrollmentApril 17, 2015
Conditionsgastric cancer
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- gastric cancer
- Sponsor
- Japan Clinical Oncology Group (JCOG)
- Enrollment
- 245
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Not specified
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