Glottic T1, Head and Neck Squamous Cell Carcinoma
Conditions
Keywords
Transoral laser microsurgery, Accelerated radiotherapy
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
Interventions
PROCEDURETransoral Laser Microsurgery
Sponsors
Danish Head and Neck Cancer Group
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Phase 2 prospective non-inferiority trial comparing with previous prospective collected national cohort
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| laryncegtomy free survival | 5 years | Alive with larynx |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ultimate tumor control | 5 years | Free from disease after primary treatment including salvage RT or surgery |
| Overall survival | 5 years | Death of any cause |
| Local control | 5 years | Free from disease after primary treatment |
| Radiation free survival | 5 years | survival without being treated with RT |
| any other treatment related morbidity | 5 years | Dahanca morbidity recording |
| Voice quality | 3 years | Voice Handicap Index score |
Countries
Denmark
Outcome results
None listed