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Recruiting NCT07391345

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

No phase Interventional Laryngeal Neoplasm Glottic Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Transoral CO₂ laser cordectomy (Type I-VI depending on tumor localization), VMAT radiotherapy, MRI-SABR.
Who it may be relevant to
Registry conditions: Laryngeal Neoplasm, Glottic Carcinoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Lithuania
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Procedure Transoral 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).
  • Radiation VMAT radiotherapy
    Accelerated fractionation schedule: T1N0 - 63 Gy/28 fractions; T2N0 - 65.25 Gy/29 fractions; delivered using Eclipse planning system.
  • Radiation MRI-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.

Primary outcome measures

  • Local Tumor Control Rate Assessed by Endoscopy and Imaging [Time frame: At 2 years after completion of treatment; At 5 years after completion of treatment]
Secondary outcome measures (8)
  • Laryngectomy-Free Survival (LFS) [Time frame: Up to 2 years after randomization; Up to 5 years after randomization]
  • Progression-Free Survival (PFS) [Time frame: Up to 2 years after randomization; Up to 5 years after randomization]
  • Overall Survival (OS) [Time frame: Up to 2 years after randomization; Up to 5 years after randomization]
  • Objective Voice Parameters Assessed by Acoustic Analysis (lingWAVES) [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 [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 [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 [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 [Time frame: From baseline imaging through 5 years after completion of treatment]

Eligibility criteria

Inclusion criteria

  • 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 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Lithuania · 1 center
  • Lithuanian University of Health Sciences Kaunas Clinics — Kaunas

Identifiers

NCT: NCT07391345 · BE-2-45

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗