drugset / Trial / NCT00117572

Docetaxel Based Chemotherapy Plus or Minus Induction Chemotherapy to Decrease Events in Head and Neck Cancer (DeCIDE)

NCT00117572

Phase 3 Completed 285 enrolled University of Chicago
RandomizedParallel-groupOpen-labelTreatment

Summary

The combined use of chemotherapeutic drugs with radiation has proven to be effective in improving overall survival and local control among patients with locally advanced head and neck cancer. Induction chemotherapy given before receiving local treatment has been shown to reduce the rate of distant failure. Many drugs have been found to prevent tumor cells from growing or dividing, although it has yet to be determined which agent, or specific combination of agents, is most effective in treating head and neck cancer. Docetaxel is a drug which has been reported to show promising activity in Phase II head and neck cancer studies. Therefore, the purpose of this trial is to compare the effectiveness of induction chemotherapy followed by chemoradiotherapy versus the same chemoradiotherapy alone in patients with locally advanced head and neck cancer.

Timeline

Start
2004-11
Primary completion
2016-12
Completion
2016-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Cisplatin Other / unclassified 75 mg/m2
Comparator Docetaxel Small molecule 25 mg/m2
Comparator Hydroxyurea Other / unclassified 500 mg Oral
Comparator fluorouracil Small molecule 600 mg/m2