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

NCT07391345 | Recruiting

• 1 other identifier: BE-2-45
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Laryngeal Neoplasm; Glottic Carcinoma

Keywords

Early-stage glottic laryngeal cancer; transoral laser microsurgery; VMAT; MRI-SABR; stereotactic radiotherapy; radiomics; dosiomics

Outcome Measures

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.

  At 2 years after completion of treatment; At 5 years after completion of treatment

Secondary Outcomes (8)

• Laryngectomy-Free Survival (LFS)

  Up to 2 years after randomization; Up to 5 years after randomization

• Progression-Free Survival (PFS)

  Up to 2 years after randomization; Up to 5 years after randomization

• Overall Survival (OS)

  Up to 2 years after randomization; Up to 5 years after randomization

• Objective Voice Parameters Assessed by Acoustic Analysis (lingWAVES)

  Baseline, and at 1, 3, 6, 12, 18, and 24 months after completion of treatment

• Patient-Reported Voice Outcome Assessed by Voice Screen Application

  Baseline, and at 1, 3, 6, 12, 18, and 24 months after completion of treatment

Study Arms (3)

Arm A: Transoral CO₂ Laser Microsurgery (TLM)

ACTIVE COMPARATOR

Participants undergo transoral CO₂ laser microsurgery for the treatment of early-stage glottic laryngeal cancer.

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

Arm B: Volumetric Modulated Arc Therapy (VMAT)

ACTIVE COMPARATOR

Participants receive definitive external beam radiotherapy using volumetric modulated arc therapy.

Radiation: VMAT radiotherapy

Arm C: MRI-Guided Stereotactic Ablative Radiotherapy (MRI-SABR)

ACTIVE COMPARATOR

Participants receive definitive MRI-guided stereotactic ablative radiotherapy.

Radiation: MRI-SABR

Interventions

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.

Arm C: MRI-Guided Stereotactic Ablative Radiotherapy (MRI-SABR)

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

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

Arm A: Transoral CO₂ Laser Microsurgery (TLM)

VMAT radiotherapy RADIATION

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

Arm B: Volumetric Modulated Arc Therapy (VMAT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Viktoras Rudzianskas: lead

Study Sites (1)

Lithuanian University of Health Sciences Kaunas Clinics

Kaunas, Lithuania

RECRUITING

MeSH Terms

Conditions

Laryngeal Neoplasms

Condition Hierarchy (Ancestors)

Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Laryngeal Diseases; Respiratory Tract Diseases; Respiratory Tract Neoplasms; Otorhinolaryngologic Diseases

Central Study Contacts

Viktoras Rudzianskas

CONTACT

+37068745515; viktoras.rudzianskas@kaunoklinikos.lt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator, Associate professor

Study Record Dates

• First Submitted: January 15, 2026
• First Posted: February 5, 2026
• Study Start: September 1, 2024
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): March 1, 2034
• Last Updated: February 5, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

LI (1)