A Randomized Phase III Study Comparing Intravenous Versus Subcutaneous Administration of Amifostine in Prevention of Xerostomia for Patients Receiving Radiotherapy for Head and Neck Carcinomas
Prospective randomized study in order to compare intravenous (IV) versus subcutaneous (SC)
administration of amifostine in patients receiving radiotherapy for head and neck cancer. IV
administration of amifostine is 200 mg/m2/day in a short 3-min infusion 15 to 30 min before
each fraction of radiotherapy. SC administration is 500mg/day in two slow 1.25 ml injections
at two different sites 20 to 60 min before each radiotherapy fraction. Procedure requires
antiemetic treatment and blood pressure monitoring in both arms.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Late xerostomia rate
Etienne Bardet, MD
Principal Investigator
Centre Régional de Lutte contre le Cancer de Nantes-Atlantique
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
GORTEC 2000-02
NCT00158691
March 2001
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