A Phase II Trial of Induction Chemotherapy With ND-420, Cisplatin and Fluorouracil Followed by Surgery in the Treatment of Patients With Localized Squamous Cell Carcinoma of the Esophagus

Inclusion Criteria:

* Patients must have been histologically proven esophageal carcinoma (squamous cell carcinoma).
* The tumor had to be locally advanced (stage T2-3/N0, T1-3/N+, if technically resectable with curative intent).
* Patients must be 20 years of age.
* Patients must have an ECOG performance status score 2.
* Patients must have a life expectancy of at least 12 weeks.
* Patients must be accessible for treatment and follow-up at least for one year.
* Patients must sign the informed consent form.
* Patient must have:Hemoglobin level 9 g/dl; Neutrophil count 1,500/mm3; Platelets count 100,000/mm3; Serum bilirubin level 1.0 ULN; Serum transaminase (GOT, GPT) levels 2.0 ULN; Serum Alkaline phosphatase levels 2.0 ULN; Serum creatinine level 1.5 mg/dl or Creatinine clearance rate(CrCl)60 ml/min for the institution (calculated by the Cockcroft- Gault equation).

Exclusion Criteria:

* Patient who are receiving or had received concurrent radiotherapy, chemotherapy or other anticancer treatment for esophageal carcinoma.
* Patients with known history of severe hypersensitivity reactions to any medicine or to drugs formulated with polysorbate 80.
* Major surgery within two weeks prior to entering the study, excluding port-A insertion or feeding jejunostomy surgery.
* Patients with CNS metastasis, including clinical suspicion.
* Patients with clinically detectable peripheral neuropathy 2 on the CTC criteria.
* Mental statuses of patients are not fit for clinical trial.
* Fertile men and women unless using a reliable and appropriate contraceptive method.
* Patients with pregnancy or lactating, women considering pregnancy, possible pregnancy that without using effective contraception.
* Patients who have serious concomitant illness that might be aggravated by chemotherapy, as below included:Active cardiac disease (e.g. congestive heart failure, angina, arrhythmia, acute myocardial disease or other types of heart disease requiring treatment) within 6 months period preceding entry into the study; Uncontrolled infection (e.g. active infection that uncontrolled for 2 weeks under antibiotic therapy); Retention of body fluid (e.g. pleural effusion, ascites, pericardial effusion, and edema needing treatment); History of other than esophageal cancer, except curatively treated non-melanoma skin cancer or in situ carcinoma of the esophagus; and other conditions which will be judged by physician's discretion.