drugset / Trial / NCT00169182

Induction CT by Cisplatin, 5FU With or Without Docetaxel in Patients With T3 and T4 Larynx and Hypopharynx Carcinoma

NCT00169182 ↗

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of the study is to compare two regimen of chemotherapy used as first treatment for patients with larynx or hypopharynx tumors that would be treated with total laryngectomy. The standard treatment is a combination of 2 drugs (Cisplatin and 5FU). The aim of the study is to evaluate the potential benefit of the addition of a third drug (Docetaxel) in the chemotherapy regimen. Patients will receive 3 cycles of chemotherapy. Responders to the induction treatment are treated with radiation with a purpose of larynx preservation. Non responders patients will be treated with total laryngectomy.

Timeline

Start
2001-12-15
Primary completion
2009-04
Completion
2009-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Docetaxel Small molecule 75 mg/m2 —
Background 5-FLUORONICOTINIC ACID Small molecule 750 mg/m2 Other
Background Cisplatin Other / unclassified 75 mg/m2 —