Randomized Trial of ARCON in Larynx Cancer

May 6, 2015 updated by: Radboud University Medical Center

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

345

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Local control
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
disease-free survival
Time Frame: 5 years
5 years
quality of life
Time Frame: 2 years
2 years
toxicity
Time Frame: 5 years
5 years
regional control rate
Time Frame: 2 years
2 years
larynx preservation
Time Frame: 2 years
2 years
improve the overall survival
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Collaborators

Dutch Cancer Society

Investigators

  • Principal Investigator: Johannes HA Kaanders, MD, PhD, Radboud University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2001

Primary Completion (Actual)

February 1, 2008

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

September 6, 2005

First Submitted That Met QC Criteria

September 6, 2005

First Posted (Estimate)

September 7, 2005

Study Record Updates

Last Update Posted (Estimate)

May 7, 2015

Last Update Submitted That Met QC Criteria

May 6, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 098
  • CKTO 2000-09

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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