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.
- 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.
- 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
- 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).