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Randomized Trial of ARCON in Larynx Cancer

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ClinicalTrials.gov Identifier: NCT00147732
Recruitment Status : Completed
First Posted : September 7, 2005
Last Update Posted : May 7, 2015
Sponsor:
Collaborator:
Dutch Cancer Society
Information provided by (Responsible Party):
Radboud University

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

Condition or disease Intervention/treatment Phase
Larynx Carcinoma Radiation: Accelerated radiotherapy Radiation: ARCON Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 345 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : April 2001
Actual Primary Completion Date : February 2008
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. Local control [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. larynx preservation [ Time Frame: 2 years ]
  2. regional control rate [ Time Frame: 2 years ]
  3. toxicity [ Time Frame: 5 years ]
  4. quality of life [ Time Frame: 2 years ]
  5. disease-free survival [ Time Frame: 5 years ]
  6. improve the overall survival [ Time Frame: 5 years ]


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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00147732


Locations
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, 6500 HB
University Medical centre Utrecht
Utrecht, Netherlands
United Kingdom
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT00147732     History of Changes
Other Study ID Numbers: 098
CKTO 2000-09
First Posted: September 7, 2005    Key Record Dates
Last Update Posted: May 7, 2015
Last Verified: May 2015

Keywords provided by Radboud University:
larynx carcinoma
radiotherapy
carbogen
nicotinamide

Additional relevant MeSH terms:
Carcinoma
Laryngeal Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Niacinamide
Niacin
Nicotinic Acids
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vasodilator Agents