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NCT Number: NCT07391345

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

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.

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Key information

Conditions

Laryngeal Neoplasm Glottic Carcinoma Head and Neck Neoplasms Laryngeal Diseases Laryngeal Neoplasms Neoplasms Neoplasms by Site Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lithuanian University of Health Sciences Kaunas Clinics

Kaunas, Lithuania

Location status: Recruiting

Location contact

Vita Simonyte-Verbickiene

CONTACT

[email protected]

+37067140693

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

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.

Primary outcomes

  1. 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

    Proportion of participants without local tumor recurrence, assessed by laryngoscopic examination and radiological imaging.

Secondary outcomes

  1. Laryngectomy-Free Survival (LFS)

    Time frame: Up to 2 years after randomization; Up to 5 years after randomization

    Time from randomization to total laryngectomy or death from any cause, whichever occurs first.

  2. Progression-Free Survival (PFS)

    Time frame: Up to 2 years after randomization; Up to 5 years after randomization

    Time from randomization to disease progression (local, regional, or distant) or death from any cause, whichever occurs first.

  3. Overall Survival (OS)

    Time frame: Up to 2 years after randomization; Up to 5 years after randomization

    Time from randomization to death from any cause.

  4. 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

    Objective voice parameters derived from acoustic signal analysis using the lingWAVES system.

  5. 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

    Patient-reported voice outcome assessed using the Voice Screen mobile application.

  6. 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

    Swallowing function assessed using the Anderson Dysphagia Inventory questionnaire (total score).

  7. 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

    Health-related quality of life assessed using the EORTC QLQ-C30 and QLQ-H&N35 questionnaires (global health status and domain scores).

  8. 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

    Quantitative radiomic feature values extracted from baseline and follow-up imaging (CT, MRI, PET/CT) and quantitative dosiomic feature values derived from radiotherapy treatment plans. Associations with clinical outcomes (local tumor control, progression-free survival, overall survival) will be summarized using correlation coefficients and hazard ratios.

Study contacts

Contact information is provided by the study sponsor or research team.

Viktoras Rudzianskas

CONTACT

[email protected]

+37068745515

Sponsors and collaborators

Lead sponsor

Viktoras Rudzianskas

Other

Registry information

Official study 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

Acronym: SMART - 1_1

Important dates

Study start
2024
Primary completion
2029
Study completion
2034
First posted
Feb 5, 2026
Registry last updated
Feb 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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