Clinical trial · Interventional
Precision Medicine: MRI-Guided Stereotactic Ablative Radiotherapy (MRI-SABR) for Early-Stage Glottic Laryngeal Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glottic Carcinoma | Glottis Carcinoma | ALIAS | 0.90 |
| Laryngeal Neoplasm | Laryngeal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MRI-SABR | Radiation | — | UNRESOLVED |
| Transoral CO₂ laser cordectomy (Type I-VI depending on tumor localization) | Procedure | — | UNRESOLVED |
| VMAT radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Arm A: Transoral CO₂ Laser Microsurgery (TLM)
- description
- Participants undergo transoral CO₂ laser microsurgery for the treatment of early-stage glottic laryngeal cancer.
- interventionNames
- Procedure: Transoral CO₂ laser cordectomy (Type I-VI depending on tumor localization)
- type
- ACTIVE_COMPARATOR
- label
- Arm B: Volumetric Modulated Arc Therapy (VMAT)
- description
- Participants receive definitive external beam radiotherapy using volumetric modulated arc therapy.
- interventionNames
- Radiation: VMAT radiotherapy
- type
- ACTIVE_COMPARATOR
- label
- Arm C: MRI-Guided Stereotactic Ablative Radiotherapy (MRI-SABR)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available