Clinical Trial: Randomized Trial of ARCON in Larynx Cancer
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official 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.
Brief 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
Detailed Summary:
Sponsor: Radboud University
Current Primary Outcome: Local control [ Time Frame: 2 years ]
Original Primary Outcome: Local control
Current Secondary Outcome:
- larynx preservation [ Time Frame: 2 years ]
- regional control rate [ Time Frame: 2 years ]
- toxicity [ Time Frame: 5 years ]
- quality of life [ Time Frame: 2 years ]
- disease-free survival [ Time Frame: 5 years ]
- improve the overall survival [ Time Frame: 5 years ]
Original Secondary Outcome:
- larynx preservation
- regional control rate
- toxicity
- quality of life
- disease-free survival
- improve the overall survival
Information By: Radboud University
Dates:
Date Received: September 6, 2005
Date Started: April 2001
Date Completion:
Last Updated: May 6, 2015
Last Verified: May 2015