Randomized Trial of ARCON in Larynx Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2008 by Radboud University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Dutch Cancer Society
Information provided by (Responsible Party):
Radboud University
ClinicalTrials.gov Identifier:
NCT00147732
First received: September 6, 2005
Last updated: December 15, 2011
Last verified: May 2008
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


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
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

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

No publications provided by Radboud University

Additional 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
Study First Received: September 6, 2005
Last Updated: December 15, 2011
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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
Pharmacologic Actions
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Therapeutic Uses
Vasodilator Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on September 18, 2014