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

RecruitingNAAges 18 Years - anyAllViktoras Rudzianskas
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In plain words

What the trial is, and whether it could suit you

This randomized phase III trial will compare the outcomes of three treatment modalities for early-stage glottic laryngeal cancer (T1-T2N0): transoral COโ‚‚ 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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Age โ‰ฅ18 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.
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What it tests

  • Transoral COโ‚‚ laser cordectomy (Type I-VI depending on tumor localization)
  • VMAT radiotherapy
  • MRI-SABR
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Where

1 site
Lithuanian University of Health Sciences Kaunas Clinics
Kaunas, Lithuania
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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