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

This is an interventional treatment trial for Localized Squamous Cell Carcinoma of the Esophagus Read More

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.