Phase I Dose-Escalation Study of Intensity-modulated Radiation Therapy in Patients with Locally Advanced Unresectable Esophageal Cancer
- Conditions
- Esophageal neoplasm
- Registration Number
- JPRN-UMIN000015306
- Lead Sponsor
- Department of Radiation Oncology and Image-Applied Therapy, Graduate School of Medicine and Faculty of Medicine Kyoto University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 18
Not provided
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) Uncontrolled diabetes mellitus 9) Unstable angina within 3 weeks, or with a history of myocardial infarction within 6 months. 10) Interstitial pneumonia, fibroid lung, or severe emphysema 11) With a history of cerebrovascular disorder within 6 months 12) Connective tissue disease 13) History of radiation therapy to chest 14) History of surgery for esophageal cancer
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method incidence of (1) Grade 3 or more esophagitis, (2) Grade 2 or more radiation pneumonitis, (3) Grade 2 or more conduction disorder/pericardial effusion/pericarditis/acute coronary syndrome within 90 days after intensity-modulated radiation therapy and (4) more than 60 days of treatment duration to finish a radiation therapy due to adverse events
- Secondary Outcome Measures
Name Time Method