Randomized Trial of ARCON in Larynx Cancer

Larynx Carcinoma Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00147732
• Other study ID #: 098
• Secondary ID: CKTO 2000-09
• Status: Completed
• Phase: Phase 3
• First received: September 6, 2005
• Last updated: May 6, 2015
• Start date: April 2001
• Est. completion date: April 2013

Study information

• Verified date: May 2015
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 345
• Est. completion date: April 2013
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Larynx Carcinoma

Intervention

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

Locations

Country	Name	City	State
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	University Medical centre Utrecht	Utrecht
United Kingdom	Mount Vernon Hospital	Northwood	Middlesex

Sponsors (2)

Lead Sponsor	Collaborator
Radboud University	Dutch Cancer Society

Countries where clinical trial is conducted

Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local control		2 years	No
Secondary	larynx preservation		2 years	No
Secondary	regional control rate		2 years	No
Secondary	toxicity		5 years	Yes
Secondary	quality of life		2 years	No
Secondary	disease-free survival		5 years	No
Secondary	improve the overall survival		5 years	No