A non-randomized confirmatory study of definitive chemoradiotherapy including salvage treatment in patients with clinical stage II/III esophageal carcinoma (JCOG 0909,EC-CRT+Salvage-sP3)
Phase 3
- Conditions
- esophageal neoplasm
- Registration Number
- JPRN-UMIN000003534
- 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
- 95
Inclusion Criteria
Not provided
Exclusion Criteria
1) Simultaneous or metachronous (within 5 years) double cancers , with the exception of intramucosal tumor curable with local therapy 2) Active infection requiring systemic therapy 3) fever over 38 degrees Celsius 4) Pregnant or lactating women or women of childbearing potential 5) Psychosis 6) Patients requiring systemic steroids medication 7) Serum HBs antigen positive 8) Diabetes mellitus with HbA1c of 7.0% or higher 9) Uncontrollable hypertention 10) Unstable angina within 3 weeks, or with a history of myocardial infarction within 6 months. 11) Interstitial pneumonia, fibroid lung, or severe emphysema 12) With a history of cerebrovascular disorder within 6 months 13) Drug allergy for iodic drug
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of 3-year overall survival
- Secondary Outcome Measures
Name Time Method progression-free survival, complete response rate, adverse events, delayed toxicity, salvage treatment related toxicity, esophagectomy-free survival