Randomized Trial of ARCON in Larynx Cancer
|ClinicalTrials.gov Identifier: NCT00147732|
Recruitment Status : Completed
First Posted : September 7, 2005
Last Update Posted : May 7, 2015
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.
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.
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?
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
- 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
|Condition or disease||Intervention/treatment||Phase|
|Larynx Carcinoma||Radiation: Accelerated radiotherapy Radiation: ARCON||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||345 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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.|
|Study Start Date :||April 2001|
|Actual Primary Completion Date :||February 2008|
|Actual Study Completion Date :||April 2013|
Active Comparator: 1
Radiation: Accelerated radiotherapy
68 Gy over 5.5 weeks
68 Gy over 5.5 weeks Carbogen: 98% oxygen plus 2% carbon dioxide Nicotinamide 60 mg/kg daily
- Local control [ Time Frame: 2 years ]
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00147732
|Free University Medical Centre|
|University Medical Centre Groningen|
|Leids University Medical Centre|
|Radboud University Nijmegen Medical Centre|
|Nijmegen, Netherlands, 6500 HB|
|University Medical centre Utrecht|
|Mount Vernon Hospital|
|Northwood, Middlesex, United Kingdom|
|Principal Investigator:||Johannes HA Kaanders, MD, PhD||Radboud University|