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

ConditionsLaryngeal NeoplasmGlottic Carcinoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorViktoras Rudzianskas

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

AJCC stage III-IV laryngeal cancer.

Prior radiotherapy for head and neck cancer.

Pregnancy or breastfeeding.

Contraindications for radiotherapy or inability to follow-up.

Trial design

Design model

Parallel

Treatments tested in this trial

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

    Procedure/Surgery

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

  • VMAT radiotherapy

    Radiation

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

  • MRI-SABR

    Radiation

    42.5 Gy total dose in 5 fractions, 2 fractions per week, planned with CT and MRI simulation and delivered with MRI-LINAC system.

Treatment groups

105 Participants
are divided into 3 treatment groups
Group A: Arm A: Transoral CO₂ Laser Microsurgery (TLM)Active comparator 1 intervention
Group B: Arm B: Volumetric Modulated Arc Therapy (VMAT)Active comparator 1 intervention
Group C: Arm C: MRI-Guided Stereotactic Ablative Radiotherapy (MRI-SABR)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Local 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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Viktoras Rudzianskas

Lead sponsor

Lithuanian University of Health Sciences

Sponsor institution

Source ClinicalTrials.gov
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