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

September 6, 2005
December 15, 2011
April 2001
February 2008   (final data collection date for primary outcome measure)
Local control [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Local control
Complete list of historical versions of study NCT00147732 on ClinicalTrials.gov Archive Site
  • 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 ]
  • larynx preservation
  • regional control rate
  • toxicity
  • quality of life
  • disease-free survival
  • improve the overall survival
Not Provided
Not Provided
 
Randomized Trial of ARCON in Larynx Cancer
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.

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
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Larynx Carcinoma
  • Radiation: Accelerated radiotherapy
    68 Gy over 5.5 weeks
  • Radiation: ARCON
    68 Gy over 5.5 weeks Carbogen: 98% oxygen plus 2% carbon dioxide Nicotinamide 60 mg/kg daily
  • Active Comparator: 1
    Accelerated radiotherapy
    Intervention: Radiation: Accelerated radiotherapy
  • Experimental: 2
    ARCON
    Intervention: Radiation: ARCON
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
344
February 2013
February 2008   (final data collection date for primary outcome measure)

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).
Both
19 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Netherlands,   United Kingdom
 
NCT00147732
098, CKTO 2000-09
Not Provided
Radboud University
Radboud University
Dutch Cancer Society
Principal Investigator: Johannes HA Kaanders, MD, PhD Radboud University
Radboud University
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP