MRI-guided stereotactic radiotherapy versus VMAT and CO2 laser cordectomy for early glottic 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
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 105 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Lithuanian University of Health Sciences Academic / other |
| Locations | 1 site (Kaunas) |
| Trial ID | NCT07391345 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Kaunas
- Lithuanian University of Health Sciences Kaunas Clinics — Kaunas, Lithuania (Recruiting)
Study contacts
- Study coordinator: Viktoras Rudzianskas
- Email: viktoras.rudzianskas@kaunoklinikos.lt
- Phone: +37068745515
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.