Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07391345

Precision Medicine: MRI-Guided Stereotactic Ablative Radiotherapy (MRI-SABR) for Early-Stage Glottic Laryngeal Cancer

Led by Viktoras Rudzianskas · Updated on 2026-02-05

105

Participants Needed

1

Research Sites

495 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Precision Medicine: MRI-Guided Stereotactic Ablative Radiotherapy (MRI-SABR) for Early-Stage Glottic Laryngeal Cancer

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Histologically confirmed squamous cell carcinoma of the glottic larynx, including verrucous carcinoma
  • Stage T1-T2N0 according to the 8th TNM edition
  • ECOG performance status of 0 to 2
  • Able to understand Lithuanian and complete questionnaires
  • Signed informed consent to participate
Not Eligible

You will not qualify if you...

  • AJCC stage III or IV laryngeal cancer
  • Previous radiotherapy for head and neck cancer
  • Pregnancy or breastfeeding
  • Contraindications to radiotherapy or inability to attend follow-up visits
  • Presence of another active cancer
  • Uncontrolled illnesses such as active infection, symptomatic congestive heart failure, unstable angina, or significant arrhythmia
  • Any other condition that would prevent radiotherapy or adequate follow-up as judged by the investigator

AI-Screening

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Trial Site Locations

Total: 1 location

1

Lithuanian University of Health Sciences Kaunas Clinics

Kaunas, Lithuania

Actively Recruiting

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Research Team

V

Viktoras Rudzianskas

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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