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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Local Tumor Control Rate Assessed by Endoscopy and Imaging
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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-
- •Able to understand Lithuanian and complete questionnaires.
- •Signed informed consent.
排除标准
- •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.
研究组 & 干预措施
Arm A: Transoral CO₂ Laser Microsurgery (TLM)
Participants undergo transoral CO₂ laser microsurgery for the treatment of early-stage glottic laryngeal cancer.
干预措施: Transoral CO₂ laser cordectomy (Type I-VI depending on tumor localization) (Procedure)
Arm B: Volumetric Modulated Arc Therapy (VMAT)
Participants receive definitive external beam radiotherapy using volumetric modulated arc therapy.
干预措施: VMAT radiotherapy (Radiation)
Arm C: MRI-Guided Stereotactic Ablative Radiotherapy (MRI-SABR)
Participants receive definitive MRI-guided stereotactic ablative radiotherapy.
干预措施: MRI-SABR (Radiation)
结局指标
主要结局
Local Tumor Control Rate Assessed by Endoscopy and Imaging
时间窗: 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.
次要结局
- Laryngectomy-Free Survival (LFS)(Up to 2 years after randomization; Up to 5 years after randomization)
- Progression-Free Survival (PFS)(Up to 2 years after randomization; Up to 5 years after randomization)
- Overall Survival (OS)(Up to 2 years after randomization; Up to 5 years after randomization)
- Objective Voice Parameters Assessed by Acoustic Analysis (lingWAVES)(Baseline, and at 1, 3, 6, 12, 18, and 24 months after completion of treatment)
- Patient-Reported Voice Outcome Assessed by Voice Screen Application(Baseline, and at 1, 3, 6, 12, 18, and 24 months after completion of treatment)
- Swallowing Function Score Assessed by Anderson Dysphagia Inventory(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(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(From baseline imaging through 5 years after completion of treatment)
研究者
Viktoras Rudzianskas
Principal investigator, Associate professor
Lithuanian University of Health Sciences