Randomized Trial of ARCON in Larynx Cancer
- Conditions
- Larynx Carcinoma
- Interventions
- Radiation: ARCONRadiation: Accelerated radiotherapy
- Registration Number
- NCT00147732
- Lead Sponsor
- Radboud University Medical Center
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 345
- 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 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 ARCON ARCON 1 Accelerated radiotherapy Accelerated radiotherapy
- Primary Outcome Measures
Name Time Method Local control 2 years
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (7)
Mount Vernon Hospital
🇬🇧Northwood, Middlesex, United Kingdom
University Medical centre Utrecht
🇳🇱Utrecht, Netherlands
Free University Medical Centre
🇳🇱Amsterdam, Netherlands
University Medical Centre Groningen
🇳🇱Groningen, Netherlands
Leids University Medical Centre
🇳🇱Leiden, Netherlands
Maastro Clinic
🇳🇱Maastricht, Netherlands
Radboud University Nijmegen Medical Centre
🇳🇱Nijmegen, Netherlands