DAHANCA 27 Transoral Laser Microsurgery for T1a Glottic Cancer
Trial Snapshot
- Phase
- Phase 2
- Enrollment
- 80
- Locations
- 5
- Primary Endpoint
- laryncegtomy free survival
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Transoral Laser Microsurgery
Transoral Laser Microsurgery
Intervention: Transoral Laser Microsurgery (Procedure)
Outcomes
Primary Outcomes
laryncegtomy free survival
Time Frame: 5 years
Alive with larynx
Secondary Outcomes
- any other treatment related morbidity(5 years)
- Overall survival(5 years)
- Local control(5 years)
- Ultimate tumor control(5 years)
- Voice quality(3 years)
- Radiation free survival(5 years)
Investigators
Jens Overgaard
Professor, MD
Danish Head and Neck Cancer Group