To evaluate whether Transoral Laser Microsurgery (TLM) is non-inferior compared to Accelerated Radiotherapy (accRT) in the treatment of T1aN0M0 glottic SCC
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
80
Aalborg University Hospital
Aalborg, Denmark
Department of Experimental Clinical Oncology, Aarhus University Hospital
Aarhus, Denmark
Aarhus University Hospital
Aarhus, Denmark
Rigshospitalet
Copenhagen, Denmark
laryncegtomy free survival
Alive with larynx
Time frame: 5 years
Local control
Free from disease after primary treatment
Time frame: 5 years
Ultimate tumor control
Free from disease after primary treatment including salvage RT or surgery
Time frame: 5 years
Overall survival
Death of any cause
Time frame: 5 years
Voice quality
Voice Handicap Index score
Time frame: 3 years
Radiation free survival
survival without being treated with RT
Time frame: 5 years
any other treatment related morbidity
Dahanca morbidity recording
Time frame: 5 years
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Odense University Hospital
Odense, Denmark