Randomized Trial of ARCON in Larynx Cancer

Overview

TITLE: A multicentre, randomised, phase III clinical trial comparing accelerated radiotherapy with accelerated radiotherapy plus carbogen and nicotinamide (ARCON) in clinical stage T2-4 laryngeal carcinoma. PRIMARY OBJECTIVE: Does the addition of carbogen and nicotinamide to a schedule of accelerated radiotherapy in patients with clinical stage T2-4 laryngeal carcinoma improve local primary tumour control? Definitive analysis will be performed on local control rates at two years after completion of radiotherapy. SECONDARY OBJECTIVES: Does the addition of carbogen and nicotinamide * increase the larynx preservation rate? * increase the regional control rate? * increase the toxicity of accelerated radiotherapy? * improve the overall quality of life? * improve the disease-free survival? * improve the overall survival? STUDY DESIGN: An open-label, randomised clinical trial assigning patients in a 1:1 ratio to one of the following treatment arms: * accelerated radiotherapy * accelerated radiotherapy plus carbogen and nicotinamide PATIENT CHARACTERISTICS AND NUMBER: 344 patients with clinical T2-4 laryngeal carcinoma MEASUREMENTS: * time to local failure * time to regional failure * survival with functional larynx * overall and disease-free survival * frequency and severity of complications related to radiotherapy and carbogen and nicotinamide * quality of life assessment

Conditions