Clinical trial NCT00147732: Randomized Trial of ARCON in Larynx Cancer
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Larynx Carcinoma
Keywords: larynx carcinoma
radiotherapy
carbogen
nicotinamide
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: Dutch Cancer Society
First posted: 2005-09-07
Enrollment: 345
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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).

Primary outcomes:
measure: Local control
timeFrame: 2 years
Secondary outcomes:
measure: larynx preservation
timeFrame: 2 years
measure: regional control rate
timeFrame: 2 years
measure: toxicity
timeFrame: 5 years
measure: quality of life
timeFrame: 2 years
measure: disease-free survival
timeFrame: 5 years
measure: improve the overall survival
timeFrame: 5 years
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Free University Medical Centre
city: Groningen
country: Netherlands
facility: University Medical Centre Groningen
city: Leiden
country: Netherlands
facility: Leids University Medical Centre
city: Maastricht
country: Netherlands
facility: Maastro Clinic
city: Nijmegen
country: Netherlands
facility: Radboud University Nijmegen Medical Centre
city: Utrecht
country: Netherlands
facility: University Medical centre Utrecht
city: Northwood
country: United Kingdom
facility: Mount Vernon Hospital
state: Middlesex
Study officials:
affiliation: Radboud University Medical Center
name: Johannes HA Kaanders, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Janssens GO, Langendijk JA, Terhaard CH, Doornaert PA, van den Ende P, de Jong MA, Takes RP, Span PN, Kaanders JH. Quality-of-life after radiotherapy for advanced laryngeal cancer: Results of a phase III trial of the Dutch Head and Neck Society. Radiother Oncol. 2016 May;119(2):213-20. doi: 10.1016/j.radonc.2016.02.023. Epub 2016 May 8.
citation: Janssens GO, Rademakers SE, Terhaard CH, Doornaert PA, Bijl HP, van den Ende P, Chin A, Takes RP, de Bree R, Hoogsteen IJ, Bussink J, Span PN, Kaanders JH. Improved recurrence-free survival with ARCON for anemic patients with laryngeal cancer. Clin Cancer Res. 2014 Mar 1;20(5):1345-54. doi: 10.1158/1078-0432.CCR-13-1730. Epub 2014 Jan 22.