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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: Transoral CO₂ Laser Microsurgery (TLM) | Active Comparator | Participants undergo transoral CO₂ laser microsurgery for the treatment of early-stage glottic laryngeal cancer. |
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| Arm B: Volumetric Modulated Arc Therapy (VMAT) | Active Comparator | Participants receive definitive external beam radiotherapy using volumetric modulated arc therapy. |
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| Arm C: MRI-Guided Stereotactic Ablative Radiotherapy (MRI-SABR) | Active Comparator | Participants receive definitive MRI-guided stereotactic ablative radiotherapy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transoral CO₂ laser cordectomy (Type I-VI depending on tumor localization) | Procedure | Surgical removal of the tumor with at least 2 mm margins; intraoperative frozen section biopsies; short hospitalization (1-3 days). |
| Measure | Description | Time Frame |
|---|---|---|
| Local Tumor Control Rate Assessed by Endoscopy and Imaging | Proportion of participants without local tumor recurrence, assessed by laryngoscopic examination and radiological imaging. | At 2 years after completion of treatment; At 5 years after completion of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Laryngectomy-Free Survival (LFS) | Time from randomization to total laryngectomy or death from any cause, whichever occurs first. | Up to 2 years after randomization; Up to 5 years after randomization |
| Progression-Free Survival (PFS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Viktoras Rudzianskas | Contact | +37068745515 | viktoras.rudzianskas@kaunoklinikos.lt |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lithuanian University of Health Sciences Kaunas Clinics | Recruiting | Kaunas | Lithuania |
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| VMAT radiotherapy | Radiation | Accelerated fractionation schedule: T1N0 - 63 Gy/28 fractions; T2N0 - 65.25 Gy/29 fractions; delivered using Eclipse planning system. |
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| MRI-SABR | Radiation | 42.5 Gy total dose in 5 fractions, 2 fractions per week, planned with CT and MRI simulation and delivered with MRI-LINAC system. |
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Time from randomization to disease progression (local, regional, or distant) or death from any cause, whichever occurs first.
| Up to 2 years after randomization; Up to 5 years after randomization |
| Overall Survival (OS) | Time from randomization to death from any cause. | Up to 2 years after randomization; Up to 5 years after randomization |
| Objective Voice Parameters Assessed by Acoustic Analysis (lingWAVES) | Objective voice parameters derived from acoustic signal analysis using the lingWAVES system. | Baseline, and at 1, 3, 6, 12, 18, and 24 months after completion of treatment |
| Patient-Reported Voice Outcome Assessed by Voice Screen Application | Patient-reported voice outcome assessed using the Voice Screen mobile application. | Baseline, and at 1, 3, 6, 12, 18, and 24 months after completion of treatment |
| Swallowing Function Score Assessed by Anderson Dysphagia Inventory | Swallowing function assessed using the Anderson Dysphagia Inventory questionnaire (total score). | Baseline, and at 1, 3, 6, 12, 18, and 24 months after completion of treatment |
| Health-Related Quality of Life Scores Assessed by EORTC QLQ-C30 and QLQ-H&N35 | Health-related quality of life assessed using the EORTC QLQ-C30 and QLQ-H&N35 questionnaires (global health status and domain scores). | Baseline, and at 1, 3, 6, 12, 18, and 24 months after completion of treatment |
| Quantitative Radiomic and Dosiomic Feature Values and Their Statistical Associations With Clinical Outcomes | 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. | From baseline imaging through 5 years after completion of treatment |
| ID | Term |
|---|---|
| D007822 | Laryngeal Neoplasms |
| ID | Term |
|---|---|
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D007818 | Laryngeal Diseases |
| D012140 | Respiratory Tract Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D010038 | Otorhinolaryngologic Diseases |
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