Back to resultsDAHANCA 27 Transoral Laser Microsurgery for T1a Glottic Cancer (DAHANCA 27)
Primary Purpose
Head and Neck Squamous Cell Carcinoma, Glottic T1
Status
Active
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
Transoral Laser Microsurgery
Sponsored by
About this trial
This is an interventional treatment trial for Head and Neck Squamous Cell Carcinoma focused on measuring Transoral laser microsurgery, Accelerated radiotherapy
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
Sites / Locations
- Aalborg University Hospital
- Department of Experimental Clinical Oncology, Aarhus University Hospital
- Aarhus University Hospital
- Rigshospitalet
- Odense University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Transoral Laser Microsurgery
Arm Description
Transoral Laser Microsurgery
Outcomes
Primary Outcome Measures
laryncegtomy free survival
Alive with larynx
Secondary Outcome Measures
Local control
Free from disease after primary treatment
Ultimate tumor control
Free from disease after primary treatment including salvage RT or surgery
Overall survival
Death of any cause
Voice quality
Voice Handicap Index score
Radiation free survival
survival without being treated with RT
any other treatment related morbidity
Dahanca morbidity recording
Full Information
NCT ID
NCT05289336
First Posted
March 13, 2022
Last Updated
March 13, 2022
Sponsor
Danish Head and Neck Cancer Group
1. Study Identification
Unique Protocol Identification Number
NCT05289336
Brief Title
DAHANCA 27 Transoral Laser Microsurgery for T1a Glottic Cancer
Acronym
DAHANCA 27
Official Title
DAHANCA 27 Transoral Laser Microsurgery for T1a Glottic Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 1, 2012 (Actual)
Primary Completion Date
April 30, 2016 (Actual)
Study Completion Date
May 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Danish Head and Neck Cancer Group
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Squamous Cell Carcinoma, Glottic T1
Keywords
Transoral laser microsurgery, Accelerated radiotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Sequential Assignment
Model Description
Phase 2 prospective non-inferiority trial comparing with previous prospective collected national cohort
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Transoral Laser Microsurgery
Arm Type
Experimental
Arm Description
Transoral Laser Microsurgery
Intervention Type
Procedure
Intervention Name(s)
Transoral Laser Microsurgery
Primary Outcome Measure Information:
Title
laryncegtomy free survival
Description
Alive with larynx
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Local control
Description
Free from disease after primary treatment
Time Frame
5 years
Title
Ultimate tumor control
Description
Free from disease after primary treatment including salvage RT or surgery
Time Frame
5 years
Title
Overall survival
Description
Death of any cause
Time Frame
5 years
Title
Voice quality
Description
Voice Handicap Index score
Time Frame
3 years
Title
Radiation free survival
Description
survival without being treated with RT
Time Frame
5 years
Title
any other treatment related morbidity
Description
Dahanca morbidity recording
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nina M Lyhne, MD
Organizational Affiliation
Aalborg University Hospital, Denmark
Official's Role
Study Chair
Facility Information:
Facility Name
Aalborg University Hospital
City
Aalborg
Country
Denmark
Facility Name
Department of Experimental Clinical Oncology, Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
8000 C
Country
Denmark
Facility Name
Aarhus University Hospital
City
Aarhus
Country
Denmark
Facility Name
Rigshospitalet
City
Copenhagen
Country
Denmark
Facility Name
Odense University Hospital
City
Odense
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
information can be obtained from the Dahanca database, pending legal and dataprotection accept and relevance
Learn more about this trial
DAHANCA 27 Transoral Laser Microsurgery for T1a Glottic Cancer
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