Trials / Completed
CompletedNCT00995293
Taxotere (Docetaxel) New Indication: Squamous Cell Carcinoma of the Head and Neck (SCCHN) Treatment Registration Trial
An Open-label, Randomized, Parallel-group, Multicenter Study of Neoadjuvant Docetaxel(Taxotere®) Plus Cisplatin Plus 5-fluorouracil Versus Neoadjuvant Cisplatin Plus 5-fluorouracil in Patients With Locally Advanced Inoperable Squamous Cell Carcinoma of the Head and Neck
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 240 (actual)
- Sponsor
- Sanofi · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
The Primary Objective is to evaluate the progression-free survival after treatment with docetaxel plus cisplatin plus 5-Fluorouracil (5-FU) (DCF) in comparison with cisplatin plus 5-FU (CF) in patient with locally advanced inoperable SCCHN The Secondary Objective is to evaluate and compare the clinical response rate both before and after radiotherapy, the local symptoms, the duration of response, the time to treatment failure, the survival, the toxicity and the quality of life in the 2 study groups.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | DOCETAXEL | Intravenous |
| DRUG | CISPLATIN | Intravenous |
| DRUG | 5-FLUOROURACIL | Intravenous |
Timeline
- Start date
- 2009-08-27
- Primary completion
- 2018-01-26
- Completion
- 2018-01-26
- First posted
- 2009-10-15
- Last updated
- 2018-03-02
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT00995293. Inclusion in this directory is not an endorsement.