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
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cisplatin | Other / unclassified | 70 mg/m2 | — |
| Subject | ND-420 | Unknown | 50 mg/m2 | — |
| Subject | fluorouracil | Small molecule | 700 mg/m2 | — |