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NCT05289336 Clinical Trial

DAHANCA 27 Transoral Laser Microsurgery for T1a Glottic Cancer

Head and Neck Squamous Cell Carcinoma Clinical Trial

— DAHANCA 27  

Official title:
DAHANCA 27 Transoral Laser Microsurgery for T1a Glottic Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05289336
Other study ID # DAHANCA 27
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date September 1, 2012
Est. completion date May 1, 2022

Study information
Verified date March 2022
Source Danish Head and Neck Cancer Group
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To evaluate whether Transoral Laser Microsurgery (TLM) is non-inferior compared to Accelerated Radiotherapy (accRT) in the treatment of T1aN0M0 glottic SCC

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

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 80
Est. completion date May 1, 2022
Est. primary completion date April 30, 2016
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

  • Head and Neck Squamous Cell Carcinoma
  • Squamous Cell Carcinoma of Head and Neck

Intervention

Procedure:
• Transoral Laser Microsurgery

Locations
Country Name City State
Denmark Aalborg University Hospital Aalborg
Denmark Aarhus University Hospital Aarhus
Denmark Department of Experimental Clinical Oncology, Aarhus University Hospital Aarhus
Denmark Rigshospitalet Copenhagen
Denmark Odense University Hospital Odense

Sponsors (1)
Lead Sponsor Collaborator
Danish Head and Neck Cancer Group

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary laryncegtomy free survival Alive with larynx 5 years
Secondary Local control Free from disease after primary treatment 5 years
Secondary Ultimate tumor control Free from disease after primary treatment including salvage RT or surgery 5 years
Secondary Overall survival Death of any cause 5 years
Secondary Voice quality Voice Handicap Index score 3 years
Secondary Radiation free survival survival without being treated with RT 5 years
Secondary any other treatment related morbidity Dahanca morbidity recording 5 years
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