NCT07391345Recruiting
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 · Last updated 5 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 105 (estimated)
- First submitted
- 15 Jan 2026
- Start date
- 1 Sept 2024
- Primary completion date
- Sept 2029
- Lead sponsor
- Viktoras Rudzianskas
- Diseases
- Head and neck cancer
- NCT number
- NCT07391345
What you commit to
- Study type: Interventional
- Planned participants: 105
- From 1 Sept 2024 to the primary completion date, Sept 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior radiotherapy for head and neck cancer.
- Contraindications for radiotherapy or inability to follow-up.
Other illness
- AJCC stage III-IV laryngeal cancer.
- 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.
Other
- Pregnancy or breastfeeding.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Lithuanian University of Health Sciences Kaunas Clinics Coordinator of this site? Confirm its status | Kaunas | Lithuania | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.