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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
105
Surgical removal of the tumor with at least 2 mm margins; intraoperative frozen section biopsies; short hospitalization (1-3 days).
Accelerated fractionation schedule: T1N0 - 63 Gy/28 fractions; T2N0 - 65.25 Gy/29 fractions; delivered using Eclipse planning system.
42.5 Gy total dose in 5 fractions, 2 fractions per week, planned with CT and MRI simulation and delivered with MRI-LINAC system.
Lithuanian University of Health Sciences Kaunas Clinics
Kaunas, Lithuania
RECRUITINGLocal Tumor Control Rate Assessed by Endoscopy and Imaging
Proportion of participants without local tumor recurrence, assessed by laryngoscopic examination and radiological imaging.
Time frame: At 2 years after completion of treatment; At 5 years after completion of treatment
Laryngectomy-Free Survival (LFS)
Time from randomization to total laryngectomy or death from any cause, whichever occurs first.
Time frame: Up to 2 years after randomization; Up to 5 years after randomization
Progression-Free Survival (PFS)
Time from randomization to disease progression (local, regional, or distant) or death from any cause, whichever occurs first.
Time frame: Up to 2 years after randomization; Up to 5 years after randomization
Overall Survival (OS)
Time from randomization to death from any cause.
Time frame: Up to 2 years after randomization; Up to 5 years after randomization
Objective Voice Parameters Assessed by Acoustic Analysis (lingWAVES)
Objective voice parameters derived from acoustic signal analysis using the lingWAVES system.
Time frame: Baseline, and at 1, 3, 6, 12, 18, and 24 months after completion of treatment
Patient-Reported Voice Outcome Assessed by Voice Screen Application
Patient-reported voice outcome assessed using the Voice Screen mobile application.
Time frame: Baseline, and at 1, 3, 6, 12, 18, and 24 months after completion of treatment
Swallowing Function Score Assessed by Anderson Dysphagia Inventory
Swallowing function assessed using the Anderson Dysphagia Inventory questionnaire (total score).
Time frame: Baseline, and at 1, 3, 6, 12, 18, and 24 months after completion of treatment
Health-Related Quality of Life Scores Assessed by EORTC QLQ-C30 and QLQ-H&N35
Health-related quality of life assessed using the EORTC QLQ-C30 and QLQ-H\&N35 questionnaires (global health status and domain scores).
Time frame: Baseline, and at 1, 3, 6, 12, 18, and 24 months after completion of treatment
Quantitative Radiomic and Dosiomic Feature Values and Their Statistical Associations With Clinical Outcomes
Quantitative radiomic feature values extracted from baseline and follow-up imaging (CT, MRI, PET/CT) and quantitative dosiomic feature values derived from radiotherapy treatment plans. Associations with clinical outcomes (local tumor control, progression-free survival, overall survival) will be summarized using correlation coefficients and hazard ratios.
Time frame: From baseline imaging through 5 years after completion of treatment
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