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

NCT ID: NCT02017600

Last Updated: 2020-05-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2015-04-04

Brief Summary

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.

Conditions

Localized Squamous Cell Carcinoma of the Esophagus

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Induction Chemotherapy DCF followed by Surgery

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.

Group Type: EXPERIMENTAL

ND-420

Intervention Type: DRUG

ND-420 50 mg/m2 on day1

Surgery

Intervention Type: PROCEDURE

After induction chemotherapy, participants will be receive right or left thoracotomy for curative resection by total or subtotal thoracic esophagectomy.

Cisplatin

Intervention Type: DRUG

cisplatin 70 mg/m2 on day1

fluorouracil

Intervention Type: DRUG

fluorouracil 700 mg/m2 daily, day1 to day4

Interventions

ND-420

ND-420 50 mg/m2 on day1

Intervention Type: DRUG

Surgery

After induction chemotherapy, participants will be receive right or left thoracotomy for curative resection by total or subtotal thoracic esophagectomy.

Intervention Type: PROCEDURE

Cisplatin

cisplatin 70 mg/m2 on day1

Intervention Type: DRUG

fluorouracil

fluorouracil 700 mg/m2 daily, day1 to day4

Intervention Type: DRUG

Other Intervention Names

ND-420(Nangkuang); 5-FU

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nang Kuang Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ming-Huang Chen, M.D.

Role: PRINCIPAL_INVESTIGATOR

Taipei Veterans General Hospital, Taiwan

Locations

Taipei Veterans General Hospital

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

NKCND420/201112

Identifier Type: -

Identifier Source: org_study_id