Randomized Trial of ARCON in Larynx Cancer

Radboud University Medical Center

Status and phase

Completed

Phase 3

Conditions

Larynx Carcinoma

Treatments

Radiation: Accelerated radiotherapy

Radiation: ARCON

Study type

Interventional

Funder types

Other

Identifiers

NCT00147732

CKTO 2000-09

098

Details and patient eligibility

About

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

Enrollment

345 patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

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).