DAHANCA 27 Transoral Laser Microsurgery for T1a Glottic Cancer

Danish Head and Neck Cancer Group

Status and phase: Unknown; Phase 2

Conditions: Glottic T1; Head and Neck Squamous Cell Carcinoma

Treatments: Procedure: Transoral Laser Microsurgery

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT05289336

DAHANCA 27

Details and patient eligibility

About

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

Full 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

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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80 participants in 1 patient group

Transoral Laser Microsurgery

Experimental group

Description:

Transoral Laser Microsurgery

Treatment:

Procedure: Transoral Laser Microsurgery