NCT00147732

Randomized Trial of ARCON in Larynx Cancer

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.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 345 (actual)
• Sponsor: Radboud University Medical Center · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

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

• Larynx Carcinoma

Interventions

Type	Name	Description
RADIATION	Accelerated radiotherapy	68 Gy over 5.5 weeks
RADIATION	ARCON	68 Gy over 5.5 weeks Carbogen: 98% oxygen plus 2% carbon dioxide Nicotinamide 60 mg/kg daily

Timeline

• Start date: 2001-04-01
• Primary completion: 2008-02-01
• Completion: 2013-04-01
• First posted: 2005-09-07
• Last updated: 2015-05-07

Locations

7 sites across 2 countries: Netherlands, United Kingdom