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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

NCT02017600 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2020-05-20

No results posted yet for this study

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

Interventions

DRUG

ND-420

ND-420 50 mg/m2 on day1

PROCEDURE

Surgery

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

DRUG

Cisplatin

cisplatin 70 mg/m2 on day1

DRUG

fluorouracil

fluorouracil 700 mg/m2 daily, day1 to day4

Sponsors & Collaborators

  • Nang Kuang Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Ming-Huang Chen, M.D. · Taipei Veterans General Hospital, Taiwan

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2014-12-02
Completion
2015-04-04

Countries

  • Taiwan

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02017600 on ClinicalTrials.gov