esophagus cancer
Conditions
Interventions
Two courses of docetaxel/cisplatin/5-fluorouracil chemotherapy (docetaxel 60mg/sm day1, cisplatin 70mg/sm day1, 5-fluorouracil 600mg/sm day 1 to 5) are given separated by 4-week interval, prior to the
Sponsors
Jikei university of medicine department of surgery, department of oncology and hematology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Resectable esophagus carcinoma stage II/III with no prior therapy. (2) Measurable target lesions by RECIST guidelines. (3) Pathologically proven squamous cell carcinoma of the esophagus. (4) Written informed consent is obtained. (5) An age of 20 to 75 years. (6) An ECOG performance status of 0 to 2. (7) Eligible for surgery with curative intent. (8) Life expectancy exceeding at least 3 months. (9) Major organs are in normal conditions. Hemoglobin => 9.0g/dL White blood cell count 4,000 to 12,000/mm3 Platelet count => 100,000/mm3 Serum bilirubin <= 1.5 times upper limit of normal AST, ALT <= 2.5 times upper limit of normal ALP <= 2.5 times upper limit of normal Serum creatinine <= upper limit of normal Creatinine clearance (or estimated GFR) => 60mL/min
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 (CTCAE v4.0) (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) Severe mental disorders, neurological disease (10) Pregnant or lactation women, or women with the possibility of the pregnancy. (11) Men who want let to pregnancy. (12) Patients who are judged inappropriate for the entry into this study by the investigator. (13) Active synchronous or metachronous malignancy, excepting for early stage cancers of the oral cavity, pharynx, larynx and early (stage Ia) gastric cancer.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate of neoadjuvant chemotherapy | — |
Secondary
| Measure | Time frame |
|---|---|
| pathological response, overall survival, progression free survival, adverse events, feasibility | — |
Countries
Japan
Outcome results
None listed