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OpenTrials
Completed

NCT Number: NCT00147732

Randomized Trial of ARCON in Larynx Cancer

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

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Key information

Conditions

Larynx Carcinoma Head and Neck Neoplasms Laryngeal Diseases Laryngeal Neoplasms Neoplasms Neoplasms by Site Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Free University Medical Centre, Amsterdam, Netherlands

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Accelerated radiotherapy

Radiation

68 Gy over 5.5 weeks

ARCON

Radiation

68 Gy over 5.5 weeks Carbogen: 98% oxygen plus 2% carbon dioxide Nicotinamide 60 mg/kg daily

Primary outcomes

  1. Local control

    Time frame: 2 years

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Collaborators

  • Dutch Cancer Society

Registry information

Official study 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.

Important dates

Study start
2001
Primary completion
2008
Study completion
2013
First posted
Sep 7, 2005
Registry last updated
May 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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