Phase II trial of endoscopic submucosal dissection to expand indication for early gastric cancer (JCOG0607)
- Conditions
- clinical T1 gastric cancer without submucosal invasion
- Registration Number
- JPRN-UMIN000000737
- Lead Sponsor
- Japan Clinical Oncology Group (JCOG)
- Brief Summary
See the datails via "URL releasing results" above. Also the details can be seen in the JCOG website: http://www.jcog.jp/en/trials/index.html
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 470
Not provided
1) Impossible to discontinue anticoagulant or antiplatelet medications. 2) Simultaneous or metachronous (within 5 years) double cancers except intramucosal tumor curable with local therapy. 3) Women during pregnancy or breast-feeding. 4) Psychosis. 5) Systemic steroids medication. 6) Active bacterial or fungous infection. 7) History of myocardial infarction or unstable angina pectoris within three months. 8) Uncontrollable hypertension. 9) Uncontrollable diabetes mellitus or administration 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 5-year overall survival (OS)
- Secondary Outcome Measures
Name Time Method OS in UL(-) cases, OS in UL(+) cases, recurrence-free survival (RFS), 5-year RFS with stomach, proportion of one-piece resection, proportion of pathological curative resection after EMR, adverse events, serious adverse events