Overview
This randomized phase III trial will compare the outcomes of three treatment modalities for early-stage glottic laryngeal cancer (T1-T2N0): transoral CO₂ laser microsurgery (TLM), volumetric modulated arc therapy (VMAT), and MRI-guided stereotactic ablative radiotherapy (MRI-SABR). The primary endpoint is local control (LC). Secondary endpoints include laryngectomy-free survival (LFS), progression-free survival (PFS). overall survival (OS), functional voice, swallowing and breathing outcomes, treatment-related complications, and the evaluation of radiomic and dosiomic biomarkers. Patients will be randomized in a 1:1:1 ratio. Total planned enrollment is 105.
Eligibility
Inclusion Criteria:
- Age ≥18 years.
- Histologically confirmed squamous cell carcinoma of the glottic larynx, including verrucous carcinoma.
- Stage T1-T2N0 (8th TNM edition).
- ECOG performance status 0-2.
- Able to understand Lithuanian and complete questionnaires.
- Signed informed consent.
Exclusion Criteria:
- AJCC stage III-IV laryngeal cancer.
- Prior radiotherapy for head and neck cancer.
- Pregnancy or breastfeeding.
- Contraindications for radiotherapy or inability to follow-up.
- Presence of another active malignancy.
- Uncontrolled intercurrent illness (e.g., active infection, symptomatic CHF, unstable angina, clinically significant arrhythmia) or any condition that would preclude radiotherapy or adequate follow-up per investigator judgment.
