Phase I Study of definitive chemoradiotherapy with Docetaxel, CDDP and 5-FU for Unresectable or Recurrent Esophageal Cancer
Phase 1
- Conditions
- advanced or recurrence esophageal carcinoma
- Registration Number
- JPRN-UMIN000003634
- Lead Sponsor
- Department of Surgery, Graduate School of Medicine, Osaka University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 18
Inclusion Criteria
Not provided
Exclusion Criteria
1. Patients have serious complications (heart disease, pulmonary fibrosis, interstitial pneumonia, hemorrhagic tendency and so on) 2. active infection 3. active synchronous malignancy 4. esophagotracheal or esophagobronchial fistulas 5. peripheral neuropathy or edema >= Grade 2 (CTCAE version3) 6. history of serious drug hypersensitivity 7. brain metastasis 8. pregnant or lactation women, or women with the possibility of the pregnancy and men who want let to pregnancy 9. patients who are judged inappropriate for the entry into study by the investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method to estimate the mazimum tolerated dose and the recommendeddose
- Secondary Outcome Measures
Name Time Method adverse events, response rate, overall sirvival, progression free survival