Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 9:42 PM
Ignite Modification Date:
2025-12-24 @ 9:42 PM
NCT ID:
NCT00147732
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
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
Study:
NCT00147732
Study Brief:
Protocol Section:
NCT00147732