Larynx Carcinoma
Conditions
Keywords
larynx carcinoma, radiotherapy, carbogen, nicotinamide
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
Interventions
RADIATIONAccelerated radiotherapy
68 Gy over 5.5 weeks
RADIATIONARCON
68 Gy over 5.5 weeks Carbogen: 98% oxygen plus 2% carbon dioxide Nicotinamide 60 mg/kg daily
Sponsors
Dutch Cancer Society
Radboud University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Pathological confirmed squamous cell carcinoma of the larynx. * TNM-classification (UICC 1997, appendix I): * T3-4 glottic or supraglottic carcinoma * T2 glottic carcinoma with impaired cord mobility or subglottic extension * T2 supraglottic carcinoma with invasion of mucosa of base of tongue or vallecula or invasion of the medial wall of the piriform sinus. * any N-stage, M0. * WHO performance status 0 or 1 (appendix II). * Age \> 18 years. * Written informed consent. * Quality of life questionnaire completed.
Exclusion criteria
* Prior or concurrent treatment for this tumour. * Severe stridor and adequate debulking of airway not possible. * Impaired renal function: serum creatinine above upper normal limit. * Use of nefrotoxic medication (including ACE-inhibitors) that cannot be discontinued for the duration of the radiation treatment. * Impaired hepatic function: ASAT and ALAT more than 1.5 times the upper normal limit. * Use of anti-convulsants that cannot be discontinued for the duration of the radiation treatment. * History of malignancy during the previous 5 years except basal cell carcinoma of skin, carcinoma in situ of the cervix, or superficial bladder neoplasm (pTa).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Local control | 2 years |
Secondary
| Measure | Time frame |
|---|---|
| larynx preservation | 2 years |
| regional control rate | 2 years |
| toxicity | 5 years |
| quality of life | 2 years |
| disease-free survival | 5 years |
| improve the overall survival | 5 years |
Countries
Netherlands, United Kingdom
Outcome results
None listed