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

Nang Kuang Pharmaceutical

Status and phase: Terminated; Phase 2

Conditions: Localized Squamous Cell Carcinoma of the Esophagus

Treatments: Procedure: Surgery; Drug: Cisplatin; Drug: ND-420; Drug: fluorouracil

Study type: Interventional

Funder types: Industry

Identifiers

NCT02017600

NKCND420/201112

Details and patient eligibility

About

Investigator will assign 53 patients who had been histologically proven localized squamous cell carcinoma of esophagus to receive the induction chemotherapy regimen of ND-420 50 mg/m2 on day 1, cisplatin 70 mg/m2 on day1, plus fluorouracil 700 mg/m2 daily, day1 to day4, every 3 weeks for 2 cycles and then followed by surgical resection. The successful rate of complete treatment per protocol and complete resection will be the primary variant to evaluate in our study.

Enrollment: 48 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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48 participants in 1 patient group

Induction Chemotherapy DCF followed by Surgery

Experimental group

Description:

All eligible patients will receive ND-420, Cisplatin and fluorouracil every 3 weeks for 2 cycles. After induction chemotherapy, patients will be planned to receive Surgery.

Treatment:

Drug: fluorouracil

Procedure: Surgery

Drug: Cisplatin

Drug: ND-420