advanced or recurrence esophageal carcinoma
Conditions
Interventions
Patients receive an infusion of docetaxel (50, 60 or 70mg/m2) on days 1, 22 and an infusion of cisplatin (10 mg/m2) plus a continuous infusion of 5-fluorouracil (400 mg/m2/day) on days 1-5 and 22-26.
Sponsors
Department of Surgery, Graduate School of Medicine, Osaka University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed squamous cell carcinoma of esophagus. 2. clinically confirmed T4 tumor and/or M1 LYM or M1 according to the Tumor-Node-Metastasis classification of the UICC, or recurrent esophageal carcinoma after radical esophagectomy 3. There is at least one estimative lesion. 4. Patients have never received chemoradiotherapy or radiotherapy for esophageal cancer. 5. Patients of age =>20 and 75=> at the registration. 6. Performance Status:0-2(ECOG) 7. Sufficient organ functions within two weeks before registration. 1) leukocyte >=4,000/mm3 and <=12,000/mm3 2) platelets >=100,000/mm3 3) hemoglobin >=9.0g/dl (and except from administration of blood transfusion) 4) total bilirubin <=1.5mg/dl 5) AST(GOT)/ALT(GPT): within 2 times the upper limit of normal 6) total bilirubin <=1.5 mg/dl 7) creatinine clearance >=60ml/min (following Cockcroft-Gault calculus 8) SpO2 >= 95%(at room air) 8. Written informed consent. 9. It is expected that patients survive for over 3 months.
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| to estimate the mazimum tolerated dose and the recommendeddose | — |
Secondary
| Measure | Time frame |
|---|---|
| adverse events, response rate, overall sirvival, progression free survival | — |
Countries
Japan
Contacts
Public ContactMakoto Yamasaki
Graduate School of Medicine, Osaka University Department of Surgery
Outcome results
None listed