DAHANCA 27 Transoral Laser Microsurgery for T1a Glottic Cancer

Phase 2

• Conditions: Head and Neck Squamous Cell Carcinoma; Glottic T1
• Interventions: Procedure: Transoral Laser Microsurgery

• Registration Number: NCT05289336
• Lead Sponsor: Danish Head and Neck Cancer Group

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 Timeline

• Study Start: 2012-09-01
• Primary Completion: 2016-04-30
• Status Verified: 2022-03
• Study First Submitted: 2022-03-13
• Study First Submitted QC: 2022-03-13
• Last Update Submitted: 2022-03-13
• Study First Posted: 2022-03-21
• Last Update Posted: 2022-03-21
• Study Completion: 2022-05-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Transoral Laser Microsurgery	Transoral Laser Microsurgery	Transoral Laser Microsurgery

Primary Outcome Measures

Name	Time	Method
laryncegtomy free survival	5 years	Alive with larynx

Secondary Outcome Measures

Name	Time	Method
any other treatment related morbidity	5 years	Dahanca morbidity recording
Local control	5 years	Free from disease after primary treatment
Ultimate tumor control	5 years	Free from disease after primary treatment including salvage RT or surgery
Overall survival	5 years	Death of any cause
Voice quality	3 years	Voice Handicap Index score
Radiation free survival	5 years	survival without being treated with RT

Trial Locations

Locations (5)

Aarhus University Hospital; 🇩🇰 Aarhus, Denmark

Rigshospitalet; 🇩🇰 Copenhagen, Denmark

Aalborg University Hospital; 🇩🇰 Aalborg, Denmark

Department of Experimental Clinical Oncology, Aarhus University Hospital; 🇩🇰 Aarhus, Denmark

Odense University Hospital; 🇩🇰 Odense, Denmark