Precision Medicine: MRI-Guided Stereotactic Ablative Radiotherapy (MRI-SABR) for Early-Stage Glottic Laryngeal Cancer (SMART - 1_1)

Viktoras Rudzianskas

Status: Enrolling

Conditions: Glottic Carcinoma; Laryngeal Neoplasm

Treatments: Procedure: Transoral CO₂ laser cordectomy (Type I-VI depending on tumor localization); Radiation: MRI-SABR; Radiation: VMAT radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT07391345

BE-2-45

Details and patient eligibility

About

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.

Enrollment: 105 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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105 participants in 3 patient groups

Arm A: Transoral CO₂ Laser Microsurgery (TLM)

Active Comparator group

Description:

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

Treatment:

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

Arm B: Volumetric Modulated Arc Therapy (VMAT)

Active Comparator group

Description:

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

Treatment:

Radiation: VMAT radiotherapy

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

Active Comparator group

Description:

Participants receive definitive MRI-guided stereotactic ablative radiotherapy.

Treatment:

Radiation: MRI-SABR