Randomized Trial of ARCON in Larynx Cancer

[Jam]

ClinicalTrials.gov

clinicaltrials.gov

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

 

[uderim]

ClinicalTrials.gov

clinicaltrials.gov

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

What was the conclusion of the study ? No results are posted .

 

[A-Tim]

Fairly low percentage of CO2. I've read 5% in another study, and someone posted one from the 1950's recently which was 30% CO2. Not sure what is most common though.