Trials / Terminated
TerminatedNCT02017600
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
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 48 (actual)
- Sponsor
- Nang Kuang Pharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2013-08-01
- Primary completion
- 2014-12-02
- Completion
- 2015-04-04
- First posted
- 2013-12-23
- Last updated
- 2020-05-20
Locations
1 site across 1 country: Taiwan
Source: ClinicalTrials.gov record NCT02017600. Inclusion in this directory is not an endorsement.