Larynx CarcinomaPhase 3NCT00147732
Randomized Trial of ARCON in Larynx Cancer
A Phase 3 study testing Accelerated radiotherapy and ARCON in people with Larynx Carcinoma, run by Radboud University Medical Center at 7 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Larynx Carcinoma
- What is being tested?
- Accelerated radiotherapy and ARCON
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 345 participants
- Where
- 7 sitesin 2 countries
- Study dates
- Apr 2001to Apr 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 10Show fewer
- WHO performance status 0 or 1 (appendix II).
- Age > 18 years.
- Written informed consent.
- Quality of life questionnaire completed.
Who cannot join
- 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).
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
Netherlands6 sites
Free University Medical Centre
Amsterdam
University Medical Centre Groningen
Groningen
Leids University Medical Centre
Leiden
Maastro Clinic
Maastricht
Radboud University Nijmegen Medical Centre
Nijmegen, 6500 HB
University Medical centre Utrecht
Utrecht
About this study
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.
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.
Read more
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
- Conditions
- Larynx Carcinoma
- Being tested
- Accelerated radiotherapy, ARCON
- Keywords
- larynx carcinoma, radiotherapy, carbogen, nicotinamide
- Medical subject headings
- Laryngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Accelerated radiotherapyRadiation
68 Gy over 5.5 weeks
ARCONRadiation
68 Gy over 5.5 weeks Carbogen: 98% oxygen plus 2% carbon dioxide Nicotinamide 60 mg/kg daily
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Accelerated radiotherapy Receives: Radiation: Accelerated radiotherapy |
| 2 | Experimental | ARCON Receives: Radiation: ARCON |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local control
Measured: 2 years
Secondary outcomes (6)
larynx preservation
Measured: 2 years
regional control rate
Measured: 2 years
toxicity
Measured: 5 years
quality of life
Measured: 2 years
disease-free survival
Measured: 5 years
improve the overall survival
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2005 (estimated)
- Study startApr 2001
- Primary completionFeb 2008
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Larynx CarcinomaStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 345 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Dutch Cancer Society
- Responsible party
- Sponsor
- Investigators
- Johannes HA Kaanders, MD, PhD, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00147732
- Sponsor's protocol ID
- 098
- Other IDs
- CKTO 2000-09
- Status last verified
- May 2015
- First submitted
- 6 Sep 2005
- Last updated
- 7 May 2015
- Results posted
- No
Publications
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.
PubMed 27165613Janssens 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.
PubMed 24452791
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00147732
- Acronym / sponsor ID
- 098
- Conditions
- Larynx Carcinoma
- Keywords
- larynx carcinoma, radiotherapy, carbogen, nicotinamide
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 345 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Dutch Cancer Society
- Study start
- Apr 2001
- Primary completion
- Feb 2008 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 7 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Radiation: Accelerated radiotherapyAccelerated radiotherapy |
| 2 | Experimental | Radiation: ARCONARCON |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Accelerated radiotherapy68 Gy over 5.5 weeks | Radiation | 1 |
| ARCON68 Gy over 5.5 weeks Carbogen: 98% oxygen plus 2% carbon dioxide Nicotinamide 60 mg/kg daily | Radiation | 2 |
Primary outcome
Local control
Time frame: 2 years
6 secondary outcomes
larynx preservation
Time frame: 2 years
regional control rate
Time frame: 2 years
toxicity
Time frame: 5 years
quality of life
Time frame: 2 years
disease-free survival
Time frame: 5 years
improve the overall survival
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2015.
- Derived from this study: PubMed 27165613Janssens 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.
- Derived from this study: PubMed 24452791Janssens 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johannes HA Kaanders, MD, PhD principal investigator
Radboud University Medical Center
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Accelerated radiotherapy and ARCON in people with Larynx Carcinoma, run by Radboud University Medical Center at 7 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Netherlands, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local control (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00147732, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2015.