esophageal cancer
Conditions
Interventions
Docetaxel/cisplatin/5-fluorouracil (docetaxel 60 mg/sm day1, cisplatin 70 mg/sm day1, 5-fluorouracil 600 mg/sm day1-5) given every 4 weeks
Sponsors
Jikei university school of medicine, department of oncology and hematology, department of gastroenterological surgery
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Pathologically proven advanced esophageal cancer (Stage II to IV). (2) Written informed consent is obtained from patient. (3) Major organs are in normal conditions. Hemoglobin => 8.0g/dL White blood cell count 3,000 to 12,000/mm3 Neutrophil count => 1,500/mm3 Platelet count => 80,000/mm3 Serum bilirubin <= 2.0 times upper limit of normal AST, ALT <= 3.0 times upper limit of normal Serum creatinine <= 1.4 mg/dL
Exclusion criteria
Exclusion criteria: (1) Known hypersensitivity to taxanes, platinum, fluoropyrimidines. Known dihydropyrimidine-dehydrogenase (DPD) deficit. (2) Pre-existing motor or sensory neurotoxicity of a severity => Grade2 (3) Active infectious diseases. (4) Symptomatic bleeding tendency, coagulation disorder, or coagulation factor deficiency. (5) Uncontrollable hypertension, uncontrollable diabetes, unstable angina, or heart failure. (6) Pre-existing renal insufficiency or proteinuria => 2+. (7) Clinical or radiographic signs of interstitial pneumonia or pulmonary fibrosis. (8) Active gastrointestinal bleeding, bowel obstruction. (9) Patients who are judged inappropriate for the entry into this study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| duration of response, time to progression, time to treatment failure, overall survival, feasibility | — |
Countries
Japan
Contacts
Public ContactYasuhiro Arakawa
Jikei university school of medicine Department of oncology and hematology
Outcome results
None listed