Randomized Trial of ARCON in Larynx Cancer - Full Text View

Sponsors and Collaborators:	Radboud University Dutch Cancer Society
Information provided by:	Radboud University
ClinicalTrials.gov Identifier:	NCT00147732

Purpose

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

Condition	Intervention	Phase
Larynx Carcinoma	Radiation: Accelerated radiotherapy Radiation: ARCON	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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.

Resource links provided by NLM:

MedlinePlus related topics: Cancer Radiation Therapy

Drug Information available for: Niacin Niacinamide Niacin hydrochloride Carbogen

U.S. FDA Resources

Further study details as provided by Radboud University:

Primary Outcome Measures:

Local control [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

larynx preservation [ Time Frame: 2 years ] [ Designated as safety issue: No ]
regional control rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
toxicity [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
quality of life [ Time Frame: 2 years ] [ Designated as safety issue: No ]
disease-free survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
improve the overall survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	344
Study Start Date:	April 2001
Estimated Study Completion Date:	February 2013
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Accelerated radiotherapy	Radiation: Accelerated radiotherapy 68 Gy over 5.5 weeks
2: Experimental ARCON	Radiation: ARCON 68 Gy over 5.5 weeks Carbogen: 98% oxygen plus 2% carbon dioxide Nicotinamide 60 mg/kg daily

Eligibility

Ages Eligible for Study:	19 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00147732

Locations

Netherlands
Radboud University Nijmegen Medical Centre
Nijmegen, Netherlands, 6500 HB
University Medical centre Utrecht
Utrecht, Netherlands
University Medical Centre Groningen
Groningen, Netherlands
Leids University Medical Centre
Leiden, Netherlands
Maastro Clinic
Maastricht, Netherlands
Free University Medical Centre
Amsterdam, Netherlands
United Kingdom, Middlesex
Mount Vernon Hospital
Northwood, Middlesex, United Kingdom

Sponsors and Collaborators

Radboud University

Dutch Cancer Society

Investigators

Principal Investigator:

Johannes HA Kaanders, MD, PhD

Radboud University

More Information

No publications provided

Responsible Party:	Radboud University Medical Centre ( Prof. J. Kaanders )
Study ID Numbers:	098, CKTO 2000-09
Study First Received:	September 6, 2005
Last Updated:	May 20, 2008
ClinicalTrials.gov Identifier:	NCT00147732 History of Changes
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Radboud University:

larynx carcinoma
radiotherapy
carbogen
nicotinamide

Study placed in the following topic categories:

Antimetabolites
Vasodilator Agents
Vitamin B Complex
Otorhinolaryngologic Neoplasms
Otorhinolaryngologic Diseases
Niacinamide
Carbogen
Laryngeal Carcinoma
Antilipemic Agents
Trace Elements
Laryngeal Neoplasms
Cardiovascular Agents

Carcinoma
Nicotinamide
Nicotinic Acids
Vitamin B3
Respiratory Tract Diseases
Vitamins
Head and Neck Neoplasms
Micronutrients
Laryngeal Diseases
Nicotinic Acid
Niacin
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Antimetabolites
Vasodilator Agents
Otorhinolaryngologic Neoplasms
Niacinamide
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Nicotinic Acids
Neoplasms by Site
Respiratory Tract Diseases
Therapeutic Uses
Vitamins
Laryngeal Diseases
Micronutrients
Respiratory Tract Neoplasms

Otorhinolaryngologic Diseases
Neoplasms by Histologic Type
Vitamin B Complex
Growth Substances
Antilipemic Agents
Laryngeal Neoplasms
Cardiovascular Agents
Pharmacologic Actions
Carcinoma
Neoplasms
Head and Neck Neoplasms
Niacin
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on September 04, 2009