A phase II study of definitive chemoradiation therapy using docetaxel, nedaplatin, and 5-fluorouracil with modified dose radiation (mDNF-R) followed by S-1 maintenance therapy and salvage therapy for patients with clinical stage IB-IIIC (non-T4) esophageal carcinoma
Not Applicable
- Conditions
- Esophageal carcinoma
- Registration Number
- JPRN-UMIN000025109
- Lead Sponsor
- Sapporo Medical University School of Medicine, Department of Medical Oncology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
Not provided
Exclusion Criteria
(1) prior chemotherapy and radiotherapy (2) history of drug hypersensitivity (3) contraindication for docetaxel, nedaplatin , 5-FU, or G-CSF (4) active concomitant malignancy. (5) severe heart disease (6) severe diabetes mellitus, severe hypertension, active infection (7) interstitial pneumonia or pulmonary fibrosis (8) pregnant or lactating females (9) high fever (10) the investigator considers not suitable for the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1-year progression free survival
- Secondary Outcome Measures
Name Time Method Overall survival Safety Radiation related adverse events Salvage therapy related adverse events Response rate Completion rate for S-1 maintenance therapy