RecruitingNot ApplicableNCT07391345

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


Sponsor

Viktoras Rudzianskas

Enrollment

105 participants

Start Date

Sep 1, 2024

Study Type

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing MRI-guided stereotactic ablative radiotherapy (MRI-SABR) — a highly precise form of radiation therapy — for early-stage glottic laryngeal cancer (cancer of the vocal cords). The goal is to deliver radiation more accurately to the tumor while protecting surrounding healthy tissue, potentially preserving the patient's voice and quality of life. **You may be eligible if...** - You are 18 or older - You have been diagnosed with squamous cell carcinoma of the vocal cords (glottic larynx), confirmed by biopsy - Your cancer is early stage (T1–T2, no lymph node involvement) - Your general health is reasonably good (ECOG score 0–2) - You are able to understand Lithuanian and complete questionnaires **You may NOT be eligible if...** - Your cancer is at an advanced stage (stage III–IV) - You have previously had radiation therapy for head and neck cancer - You are pregnant or breastfeeding - You have another active cancer - You have serious uncontrolled medical conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURETransoral CO₂ laser cordectomy (Type I-VI depending on tumor localization)

Surgical removal of the tumor with at least 2 mm margins; intraoperative frozen section biopsies; short hospitalization (1-3 days).

RADIATIONVMAT radiotherapy

Accelerated fractionation schedule: T1N0 - 63 Gy/28 fractions; T2N0 - 65.25 Gy/29 fractions; delivered using Eclipse planning system.

RADIATIONMRI-SABR

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)

Lithuanian University of Health Sciences Kaunas Clinics

Kaunas, Lithuania

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NCT07391345


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