Single-arm confirmatory study on efficacy of combined treatment of endoscopic mucosal resection and chemoradiotherapy for clinical stage I esophageal carcinoma (JCOG0508)
Phase 3
- Conditions
- clinical stage I (SM1-2) esophageal cancer
- Registration Number
- JPRN-UMIN000000553
- Lead Sponsor
- Japan Clinical Oncology Group(JCOG)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 82
Inclusion Criteria
Not provided
Exclusion Criteria
1) Iodine allergy 2) Impossible to discontinue anticoagulant or antiplatelet medications 3) Simultaneous or metachronous (within 5 years) double cancers except intramucosal tumor curable with local therapy 4) Women during pregnancy or breast-feeding 5) Psychosis 6) Systemic steroids medication 7) HBs antigen positive 8) Active bacterial or fungous infection 9) History of myocardial infarction within three months or unstable angina pectoris 10) Uncontrollable hypertension 11) Uncontrollable diabetes millutus or administration of insulin 12) Interstitial pneumonia, fibroid lung or severe emphysema
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 3-year overall survival in 'pM1-3, vascular invasion positive and margin negative cases' or 'pSM1-2 and margin negative cases'
- Secondary Outcome Measures
Name Time Method 3-year overall survival in all registered cases, progression-free survival in all registered cases, overall survival in pM1-3 and margin negative cases, overall survival in pM1-3, vascular invasion positive and margin negative cases, adverse events of EMR, adverse events of chemoradiotherapy