Larynx Carcinoma Clinical Trial
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.
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
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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