Single-arm confirmatory study of endoscopic submucosal dissection for expand indication to early gastric cancer of undifferentiated type (JCOG1009/1010, Undiff GC ESD)
Phase 3
- Conditions
- clinical T1a (M) gastric cancer
- Registration Number
- JPRN-UMIN000004995
- 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
- 346
Inclusion Criteria
Not provided
Exclusion Criteria
1) Simultaneous or metachronous (within 5 years) double cancers except intramucosal tumor curable with local therapy. 2) Infectious disease with systemic therapy indicated. 3) Body temperature of 38 or more degrees Celsius. 4) Women during pregnancy or breast-feeding. 5) Psychosis. 6) Systemic steroids medication. 7) History of myocardial infarction within 6 months or unstable angina pectoris within 3 weeks. 8) Uncontrollable hypertension. 9) Severe respiratory disease requiring continuous oxygen therapy. 10) Impossible to suspend anticoagulant or antiplatelet medications. 11) Uncontrollable diabetes millutus or administration of insulin.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method % 5-year overall survival in patients with undifferentiated dominant type diagnosed in the ESD specimen.
- Secondary Outcome Measures
Name Time Method OS, relapse-free survival (RFS), distant metastasis-free survival, % 5-year survival without either reccurece or gastrectomy, % enbloc resection with ESD, % pathological curative resection with ESD, % 5-year OS in patients with differentiated dominant type diagnosed in the ESD specimen, % 5-year OS in patients with pathological curative resection with ESD, adverse events, serious adverse events