Precision Medicine: MRI-Guided Stereotactic Ablative Radiotherapy (MRI-SABR) for Early-Stage Glottic Laryngeal Cancer

A Prospective, Randomized, Three-Arm, Open-Label Clinical Trial Comparing Transoral CO₂ Laser Microsurgery, Volumetric Modulated Arc Therapy (VMAT), and MRI-Guided Stereotactic Ablative Radiotherapy (MRI-SABR) in the Treatment of Early-Stage Glottic Laryngeal Cancer

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.

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.