locally advanced esophageal carcinoma
Conditions
Interventions
Patients receive an infusion of docetaxel (35 mg/m2) and an infusion of cisplatin (40 mg/m2) on days 1, 15, and 29 plus a continuous infusion of 5-fluorouracil (400 mg/m2/day) on days 1-5, 15-19, and
Sponsors
Kitasato University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed squamous cell carcinoma, adenocarcinoma, adenosquamous carcinoma, basaloid carcinoma of esophagus. 2. Primary tumor localizes the thoracic esophagus by esophagography. 3. clinically confirmed T4 tumor and/or M1 LYM according to the Tumor-Node-Metastasis classification of the UICC. All areas of nodal disease had to be able to be contained in the radiation field. 4. No other distant metastasis, pleural effusion, ascites, and esophagotracheal or esophagobronchial fistulas. 5. Patients of age =>20 and 75=> at the registration. 6. Patients have never received surgical resection (excepting for endoscopic resection), radiation, or chemotherapy for esophageal cancer. 7. Sufficient organ functions within one week before registration. 1) leukocyte >=3,000/mm3 2) platelets >=100,000/mm3 3) hemoglobin >=10.0g/dl 4) total bilirubin <=1.5mg/dl 5) AST(GOT)/ALT(GPT): within 2 times the upper limit of normal 6) serum creatinine: within the upper limit of normal 7) creatinine clearance >=50ml/min 8) normal ECG 8. Performance Status:0-2(ECOG) 9. Written informed consent.
Exclusion criteria
Exclusion criteria: 1. History of serious drug hypersensitivity 2. Active gastrointestinal bleeding 3. Active infection 4. Severe complication (interstitial pneumonia or pulmonary fibrosis, poorly controlled diabetes mellitus, heart failure, renal failure, liver cirrhosis or etc) 5. Active synchronous or metachronous malignancy other than carcinoma in situ. 6. Mental disorders being treated with antipsychotic agents or requiring treatment 7. Pregnant or lactation women, or women with the possibility of the pregnancy 8. Men who want let to pregnancy 9. Patients who are judged inappropriate for the entry into the study by the investigater
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| complete response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Response rate Adverse events Progression free survival(PFS) Overall Survival(OS) | — |
Countries
Japan
Outcome results
None listed