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

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.