drugset / Trial / NCT02017600

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 ↗

Phase 2 Terminated 48 enrolled Nang Kuang Pharmaceutical Co., Ltd.
NaSingle-groupOpen-labelTreatment

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Cisplatin Other / unclassified 70 mg/m2 —
Subject ND-420 Unknown 50 mg/m2 —
Subject fluorouracil Small molecule 700 mg/m2 —