Glottic Carcinoma, Laryngeal Neoplasm
Conditions
Keywords
Early-stage glottic laryngeal cancer, transoral laser microsurgery, VMAT, MRI-SABR, stereotactic radiotherapy, radiomics, dosiomics
Brief 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.
Interventions
PROCEDURETransoral 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).
RADIATIONVMAT radiotherapy
Accelerated fractionation schedule: T1N0 - 63 Gy/28 fractions; T2N0 - 65.25 Gy/29 fractions; delivered using Eclipse planning system.
RADIATIONMRI-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.
Sponsors
Viktoras Rudzianskas
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Local Tumor Control Rate Assessed by Endoscopy and Imaging | At 2 years after completion of treatment; At 5 years after completion of treatment | Proportion of participants without local tumor recurrence, assessed by laryngoscopic examination and radiological imaging. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Laryngectomy-Free Survival (LFS) | Up to 2 years after randomization; Up to 5 years after randomization | Time from randomization to total laryngectomy or death from any cause, whichever occurs first. |
| Progression-Free Survival (PFS) | Up to 2 years after randomization; Up to 5 years after randomization | Time from randomization to disease progression (local, regional, or distant) or death from any cause, whichever occurs first. |
| Overall Survival (OS) | Up to 2 years after randomization; Up to 5 years after randomization | Time from randomization to death from any cause. |
| Objective Voice Parameters Assessed by Acoustic Analysis (lingWAVES) | Baseline, and at 1, 3, 6, 12, 18, and 24 months after completion of treatment | Objective voice parameters derived from acoustic signal analysis using the lingWAVES system. |
| Patient-Reported Voice Outcome Assessed by Voice Screen Application | Baseline, and at 1, 3, 6, 12, 18, and 24 months after completion of treatment | Patient-reported voice outcome assessed using the Voice Screen mobile application. |
| Swallowing Function Score Assessed by Anderson Dysphagia Inventory | Baseline, and at 1, 3, 6, 12, 18, and 24 months after completion of treatment | Swallowing function assessed using the Anderson Dysphagia Inventory questionnaire (total score). |
| Health-Related Quality of Life Scores Assessed by EORTC QLQ-C30 and QLQ-H&N35 | Baseline, and at 1, 3, 6, 12, 18, and 24 months after completion of treatment | Health-related quality of life assessed using the EORTC QLQ-C30 and QLQ-H\&N35 questionnaires (global health status and domain scores). |
| Quantitative Radiomic and Dosiomic Feature Values and Their Statistical Associations With Clinical Outcomes | From baseline imaging through 5 years after completion of treatment | Quantitative radiomic feature values extracted from baseline and follow-up imaging (CT, MRI, PET/CT) and quantitative dosiomic feature values derived from radiotherapy treatment plans. Associations with clinical outcomes (local tumor control, progression-free survival, overall survival) will be summarized using correlation coefficients and hazard ratios. |
Countries
Lithuania
Contacts
CONTACTViktoras Rudzianskas
Outcome results
None listed