NCT00147732

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
345

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Apr 2001

Longer than P75 for phase_3

Geographic Reach
2 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2001

Completed
4.4 years until next milestone

First Submitted

Initial submission to the registry

September 6, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 7, 2005

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
5.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

May 7, 2015

Status Verified

May 1, 2015

Enrollment Period

6.8 years

First QC Date

September 6, 2005

Last Update Submit

May 6, 2015

Conditions

Larynx Carcinoma

Keywords

larynx carcinomaradiotherapycarbogennicotinamide

Outcome Measures

Primary Outcomes (1)

  • Local control

    2 years

Secondary Outcomes (6)

  • larynx preservation

    2 years

  • regional control rate

    2 years

  • toxicity

    5 years

  • quality of life

    2 years

  • disease-free survival

    5 years

  • +1 more secondary outcomes

Study Arms (2)

1

ACTIVE COMPARATOR

Accelerated radiotherapy

Radiation: Accelerated radiotherapy

2

EXPERIMENTAL

ARCON

Radiation: ARCON

Interventions

Accelerated radiotherapyRADIATION

68 Gy over 5.5 weeks

1
ARCONRADIATION

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

2

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Free University Medical Centre

Amsterdam, Netherlands

Location

University Medical Centre Groningen

Groningen, Netherlands

Location

Leids University Medical Centre

Leiden, Netherlands

Location

Maastro Clinic

Maastricht, Netherlands

Location

Radboud University Nijmegen Medical Centre

Nijmegen, 6500 HB, Netherlands

Location

University Medical centre Utrecht

Utrecht, Netherlands

Location

Mount Vernon Hospital

Northwood, Middlesex, United Kingdom

Location

Related Publications (2)

  • Janssens GO, Langendijk JA, Terhaard CH, Doornaert PA, van den Ende P, de Jong MA, Takes RP, Span PN, Kaanders JH. Quality-of-life after radiotherapy for advanced laryngeal cancer: Results of a phase III trial of the Dutch Head and Neck Society. Radiother Oncol. 2016 May;119(2):213-20. doi: 10.1016/j.radonc.2016.02.023. Epub 2016 May 8.

    PMID: 27165613DERIVED

  • 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.

    PMID: 24452791DERIVED

MeSH Terms

Conditions

Laryngeal Neoplasms

Condition Hierarchy (Ancestors)

Otorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNeoplasmsLaryngeal DiseasesRespiratory Tract DiseasesRespiratory Tract NeoplasmsOtorhinolaryngologic Diseases

Study Officials

  • Johannes HA Kaanders, MD, PhD

    Radboud University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2005

First Posted

September 7, 2005

Study Start

April 1, 2001

Primary Completion

February 1, 2008

Study Completion

April 1, 2013

Last Updated

May 7, 2015

Record last verified: 2015-05

Locations

NL(6)GB(1)