Clinical Trial

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

Study acronym: SMART - 1_1
Recruiting
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Summary
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.
Trial Details
NCT Number NCT07391345
Lead Sponsor Viktoras Rudzianskas
Conditions Laryngeal Neoplasm, Glottic Carcinoma
Enrollment 105 participants
Start Date 2024-09-01
Primary Completion 2029-09 (estimated)
Study Completion 2034-03 (estimated)
Updated on ClinicalTrials.gov 2026-02-05