Phase I study of concurrent chemoradiotherapy with docetaxel,cisplatin and 5-fluorouracil (DCF) in patients with locally advanced cancer of the external auditory canal and middle ear.
Phase 1
- Conditions
- eoplasm of the external auditory canal and middle ear
- Registration Number
- JPRN-UMIN000013304
- Lead Sponsor
- Kobe University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 12
Inclusion Criteria
Not provided
Exclusion Criteria
1) Pregnant or lactating women or women of childbearing potential 2) Psychosis 3) Patients requiring systemic steroids medication 4) HBs antigen positive 5) HCV antibody positive 6) HIV antibody positive 7) Uncontrollable diabetes millutus 8) History of myocardial infarction within three months 9) History of unstable angina pectoris or interstitial pneumonia or fibroid lung or severe emphysema 10) Active bacterial or fungous infection 11) In case of judge as inadequate subjects by attending physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Maximum tolerated dose and recommended dose
- Secondary Outcome Measures
Name Time Method frequency and severity of side effects