Randomized Trial of ARCON in Larynx Cancer
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|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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|