Trials / Recruiting
RecruitingNCT07391345
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
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 105 (estimated)
- Sponsor
- Viktoras Rudzianskas · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Transoral CO₂ laser cordectomy (Type I-VI depending on tumor localization) | Surgical removal of the tumor with at least 2 mm margins; intraoperative frozen section biopsies; short hospitalization (1-3 days). |
| RADIATION | VMAT radiotherapy | Accelerated fractionation schedule: T1N0 - 63 Gy/28 fractions; T2N0 - 65.25 Gy/29 fractions; delivered using Eclipse planning system. |
| RADIATION | MRI-SABR | 42.5 Gy total dose in 5 fractions, 2 fractions per week, planned with CT and MRI simulation and delivered with MRI-LINAC system. |
Timeline
- Start date
- 2024-09-01
- Primary completion
- 2029-09-01
- Completion
- 2034-03-01
- First posted
- 2026-02-05
- Last updated
- 2026-02-05
Locations
1 site across 1 country: Lithuania
Source: ClinicalTrials.gov record NCT07391345. Inclusion in this directory is not an endorsement.