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