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
Viktoras Rudzianskas
105 participants
Sep 1, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria6
- 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 Criteria6
- 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.
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Interventions
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.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07391345