MRI-guided stereotactic radiotherapy versus VMAT and CO2 laser cordectomy for early glottic cancer
Official 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
Run by Lithuanian University of Health Sciences · NCT07391345 · Data updated 2026-11-12
This trial will test whether MRI-guided stereotactic ablative radiotherapy (MRI-SABR) or VMAT gives better local control and voice preservation than transoral CO2 laser microsurgery in adults with early-stage (T1–T2N0) glottic cancer.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 105 (estimated) |
| Sponsor | Lithuanian University of Health Sciences Academic / other |
| Locations | 1 site (Kaunas) |
| Status | Recruiting |
| Started | September 1, 2024 |
| Main results expected | September 2029 |
| Study ends | March 2034 |
| Registry record updated | February 5, 2026 |
| Trial ID | NCT07391345 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 or older with histologically confirmed T1–T2N0 squamous cell carcinoma of the glottis, ECOG 0–2, able to understand Lithuanian and provide informed consent, who are candidates for surgery or radiotherapy.
✕Probably not a fit
Patients with stage III–IV disease, prior head and neck radiotherapy, another active malignancy, pregnancy or breastfeeding, or medical conditions that preclude radiotherapy or reliable follow-up are unlikely to benefit from this trial.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized phase III trial enrolls 105 adults with T1–T2N0 glottic squamous cell carcinoma and randomizes them 1:1:1 to transoral CO2 laser cordectomy, VMAT radiotherapy, or MRI-guided stereotactic ablative radiotherapy (MRI-SABR). The primary endpoint is local control; secondary endpoints include laryngectomy-free survival, progression-free survival, overall survival, treatment-related complications, and functional outcomes for voice, swallowing, and breathing. The protocol also collects radiomic and dosiomic data to explore imaging and dose-distribution biomarkers linked to outcomes. All treatments and follow-up occur at the Lithuanian University of Health Sciences Kaunas Clinics.
Why it matters
Potential benefit: If successful, the MRI-guided SABR approach could improve tumor control while preserving voice and reducing the need for laryngectomy and long treatment courses.
How similar studies have gone: Transoral laser microsurgery and conventional radiotherapy/VMAT have a strong track record of good local control in early glottic cancer, whereas MRI-guided SABR is a newer approach with limited prior data in this specific disease.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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Lithuanian University of Health Sciences Kaunas Clinics
Kaunas, Lithuania Recruiting
Study contacts
- Study coordinator: Viktoras Rudzianskas
- Email: viktoras.rudzianskas@kaunoklinikos.lt
- Phone: +37068745515
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.