Head and Neck Squamous Cell CarcinomaPhase 2DAHANCA 27NCT05289336
DAHANCA 27 Transoral Laser Microsurgery for T1a Glottic Cancer
A Phase 2 study testing Transoral Laser Microsurgery in people with Head and Neck Squamous Cell Carcinoma and Glottic T1, run by Danish Head and Neck Cancer Group at 5 sites in Denmark.
Trial summary
To evaluate whether Transoral Laser Microsurgery (TLM) is non-inferior compared to Accelerated Radiotherapy (accRT) in the treatment of T1aN0M0 glottic SCC Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Squamous Cell Carcinoma, Glottic T1
- What is being tested?
- Transoral Laser Microsurgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 5 sitesDenmark
- Study dates
- 1 Sep 2012to 1 May 2022
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- Danish patients aged ≥18 years diagnosed with a T1aN0M0 glottic squamous cell carcinoma (SCC)
Who cannot join
- Unable to complete curative intended protocol treatment and/or planned follow up
- informed concent
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Denmark5 sites
Aalborg University Hospital
Aalborg
Department of Experimental Clinical Oncology, Aarhus University Hospital
Aarhus, 8000 C
Aarhus University Hospital
Aarhus
Rigshospitalet
Copenhagen
Odense University Hospital
Odense
About this study
To evaluate whether Transoral Laser Microsurgery (TLM) is non-inferior compared to Accelerated Radiotherapy (accRT) in the treatment of T1aN0M0 glottic SCC
Read the detailed description
Since 2003 the Danish national standard treatment for T1aN0M0 glottic SCC has been accelerated RT (66Gy. 2 GY/fraction, 6 fractions/week). In 2012 cordectomy type I-III using TLM was introduced as an experimental treatment.
The DAHANCA 27 trial is a comparative non-inferiority phase II study comparing two timely separated national patient cohorts. Patients treated with radical TLM from September 2012 to April 2016 were included in the TLM cohort, and patients treated with accelerated RT from January 2003 to august 2012 were included in the RT cohort
- Conditions
- Head and Neck Squamous Cell Carcinoma, Glottic T1
- Being tested
- Transoral Laser Microsurgery
- Keywords
- Transoral laser microsurgery, Accelerated radiotherapy
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transoral Laser MicrosurgeryProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Transoral Laser Microsurgery | Experimental | Transoral Laser Microsurgery Receives: Procedure: Transoral Laser Microsurgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
laryncegtomy free survival
Alive with larynx
Measured: 5 years
Secondary outcomes (6)
Local control
Free from disease after primary treatment
Measured: 5 years
Ultimate tumor control
Free from disease after primary treatment including salvage RT or surgery
Measured: 5 years
Overall survival
Death of any cause
Measured: 5 years
Voice quality
Voice Handicap Index score
Measured: 3 years
Radiation free survival
survival without being treated with RT
Measured: 5 years
any other treatment related morbidity
Dahanca morbidity recording
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 posted21 Mar 2022
- Study start1 Sep 2012
- Primary completion30 Apr 2016
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Head and Neck Squamous Cell CarcinomaStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- Phase 2 prospective non-inferiority trial comparing with previous prospective collected national cohort
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danish Head and Neck Cancer Group
- Sponsor type
- Research network
- Responsible party
- Principal investigator, Jens Overgaard, Danish Head and Neck Cancer Group
- Investigators
- Nina M Lyhne, MD, Study chair, Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05289336
- Sponsor's protocol ID
- DAHANCA 27
- Acronym
- DAHANCA 27
- Status last verified
- Mar 2022
- First submitted
- 13 Mar 2022
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: information can be obtained from the Dahanca database, pending legal and dataprotection accept and relevance
Publications
Lyhne NM, Kjaergaard T, Tvedskov JF, Godballe C, Hald K, Ulhoi BP, Printz T, Overgaard J. The DAHANCA 27 Phase II Study: Transoral Laser Microsurgery for T1aN0M0 Glottic Squamous Cell Carcinoma, a Comparison to Accelerated Radiotherapy. Head Neck. 2025 Dec;47(12):3228-3236. doi: 10.1002/hed.28225. Epub 2025 Jul 7.
PubMed 40622110
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DAHANCA 27 Transoral Laser Microsurgery for T1a Glottic Cancer
- ClinicalTrials.gov ID
- NCT05289336
- Acronym / sponsor ID
- DAHANCA 27 / DAHANCA 27
- Conditions
- Head and Neck Squamous Cell Carcinoma, Glottic T1
- Keywords
- Transoral laser microsurgery, Accelerated radiotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Danish Head and Neck Cancer GroupResearch network
- Study start
- 1 Sep 2012 (actual)
- Primary completion
- 30 Apr 2016 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 21 Mar 2022 (actual)
- 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.
To evaluate whether Transoral Laser Microsurgery (TLM) is non-inferior compared to Accelerated Radiotherapy (accRT) in the treatment of T1aN0M0 glottic SCC
Detailed description
Since 2003 the Danish national standard treatment for T1aN0M0 glottic SCC has been accelerated RT (66Gy. 2 GY/fraction, 6 fractions/week). In 2012 cordectomy type I-III using TLM was introduced as an experimental treatment.
The DAHANCA 27 trial is a comparative non-inferiority phase II study comparing two timely separated national patient cohorts. Patients treated with radical TLM from September 2012 to April 2016 were included in the TLM cohort, and patients treated with accelerated RT from January 2003 to august 2012 were included in the RT cohort
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Phase 2 prospective non-inferiority trial comparing with previous prospective collected national cohort
| Arm | Type | Receives |
|---|---|---|
| Transoral Laser Microsurgery | Experimental | Procedure: Transoral Laser MicrosurgeryTransoral Laser Microsurgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Danish patients aged ≥18 years diagnosed with a T1aN0M0 glottic squamous cell carcinoma (SCC)
Key exclusion criteria (2 listed)
- Unable to complete curative intended protocol treatment and/or planned follow up
- informed concent
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 |
|---|---|---|
| Transoral Laser Microsurgery | Procedure or surgery | Transoral Laser Microsurgery |
Primary outcome
laryncegtomy free survival
Time frame: 5 years
Alive with larynx
6 secondary outcomes
Local control
Time frame: 5 years
Ultimate tumor control
Time frame: 5 years
Overall survival
Time frame: 5 years
Voice quality
Time frame: 3 years
Radiation free survival
Time frame: 5 years
any other treatment related morbidity
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 2 Nov 2026.
- Derived from this study: PubMed 40622110Lyhne NM, Kjaergaard T, Tvedskov JF, Godballe C, Hald K, Ulhoi BP, Printz T, Overgaard J. The DAHANCA 27 Phase II Study: Transoral Laser Microsurgery for T1aN0M0 Glottic Squamous Cell Carcinoma, a Comparison to Accelerated Radiotherapy. Head Neck. 2025 Dec;47(12):3228-3236. doi: 10.1002/hed.28225. Epub 2025 Jul 7.
- Individual participant dataSharing planned: Undecided. information can be obtained from the Dahanca database, pending legal and dataprotection accept and relevance
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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.
Nina M Lyhne, MD study chair
Aalborg University Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Transoral Laser Microsurgery in people with Head and Neck Squamous Cell Carcinoma and Glottic T1, run by Danish Head and Neck Cancer Group at 5 sites in Denmark.
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 1 inclusion and 2 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 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Denmark. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
laryncegtomy free survival (time frame: 5 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 NCT05289336, which also lists 1 linked publication.
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 2 Nov 2026.