DAHANCA 27 Transoral Laser Microsurgery for T1a Glottic C... | NCT05289336

Studies
DAHANCA 27 Transoral Laser Microsurgery for T1a Glottic Cancer

NCT05289336

Sponsor

Danish Head and Neck Cancer Group

Status

Unknown status

Last Update Posted

Mar 21, 2022Actual

Enrollment

80Actual

Phase

Phase 2

Conditions

Head and Neck Squamous Cell Carcinoma
Glottic T1

Interventions

Transoral Laser Microsurgery

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2012Actual

Primary Completion Date

Apr 30, 2016Actual

Completion Date

May 1, 2022Estimated

First Submitted Date

Mar 13, 2022

First Submission Date that Met QC Criteria

Mar 13, 2022

First Posted Date

Mar 21, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 13, 2022

Last Update Posted Date

Mar 21, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jens Overgaard, Professor, MD, Danish Head and Neck Cancer GroupPrincipal Investigator

Lead Sponsor

Danish Head and Neck Cancer GroupNETWORK

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Transoral Laser Microsurgery	Experimental	Transoral Laser Microsurgery	Procedure: Transoral Laser Microsurgery

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Transoral Laser Microsurgery	Procedure		Transoral Laser Microsurgery

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
laryncegtomy free survival	Alive with larynx	5 years

Secondary Outcomes

Measure	Description	Time Frame
Local control	Free from disease after primary treatment	5 years
Ultimate tumor control	Free from disease after primary treatment including salvage RT or surgery

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Danish patients aged ≥18 years diagnosed with a T1aN0M0 glottic squamous cell carcinoma (SCC)

Exclusion Criteria:

Unable to complete curative intended protocol treatment and/or planned follow up
informed concent

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Nina M Lyhne, MD	Aalborg University Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Aalborg University Hospital		Aalborg			Denmark
Department of Experimental Clinical Oncology, Aarhus University Hospital

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
40622110	Derived	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.

ID	Term
D002294	Carcinoma, Squamous Cell
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type