drugset / Trial / NCT00995293

Taxotere (Docetaxel) New Indication: Squamous Cell Carcinoma of the Head and Neck (SCCHN) Treatment Registration Trial

NCT00995293 ↗

Phase 3 Completed 240 enrolled Sanofi
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2009-08-27
Primary completion
2018-01-26
Completion
2018-01-26

Drugs

EvaluationDrugModalityDoseRoute
Subject Docetaxel Small molecule 60 mg/m2 Intravenous
Background Cisplatin Other / unclassified 75 mg/m2 Intravenous
Background fluorouracil Small molecule 750 mg/m2 Intravenous