A Randomized Study of Vocal-cord Only vs. Complete Laryngeal Radiotherapy for Early Glottic Cancer
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 155
- 试验地点
- 3
- 主要终点
- Local control
研究概览
简要总结
This is a multicentrer, randomized Bayesian Phase II trial for patients with early stage (T1N0) glottic squamous cell carcinoma treated with radical radiotherapy. The primary objective is to assess the non-inferiority of local control achieved with vocal-cord only radiotherapy (VC-RT) compared to complete larynx radiotherapy (CL-RT) in T1N0 glottic laryngeal squamous cell cancer, measured at 2-years after treatment. Secondary outcomes include overall survival, as well as voice impairment, dysphagia and quality of life, measured respectively by the voice handicap index -10 (VHI-10), the MD Anderson Dysphagia Inventory (MDADI) and the MD Anderson Symptom Inventory- Head and Neck module (MDASI-HN). Patients will be randomized in a 1:3 ratio to CL-RT (39 patients) and VC-RT (116 patients) arms. There will be stratification by tumor stage (T1a/T1b) and by institution. An interim analysis is planned after the first 55 patients enrolled on the experimental arm have a 6-month follow-up.
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
- •Stage T1a-b N0 of the true vocal cords planned for definitive RT
- •Patient not candidate for laser surgery or declined laser surgery
- •Biopsy-confirmed squamous cell carcinoma, including verrucous carcinoma
- •Eastern Cooperative Oncology Group performance status 0-2
- •Ability to provide written informed consent.
排除标准
- •Previous irradiation of the head and neck (HNC) region
- •Pregnancy or breastfeeding
- •Any medical condition that represents, in the opinion of the investigator, a contraindication to radiotherapy or would prevent follow-up after radiotherapy.
- •Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 2 years.
研究组 & 干预措施
Vocal-cord Radiotherapy
干预措施: Vocal-cord Radiotherapy (Radiation)
Complete Larynx Radiotherapy
干预措施: Complete Larynx Radiotherapy (Radiation)
结局指标
主要结局
Local control
时间窗: At 2-year follow-up
Local control rate of vocal-cord radiotherapy
次要结局
- Voice Handicap Index-10 score(Week 0 post-treatment, and at 2-month, 6-month, 1-year and 2-year follow-up)
- Time to recurrence(At 2- and 5-year follow-up)
- Overall survival(At 2- and 5-year follow-up)
- MD Anderson Dysphagia Inventory score(Week 0 post-treatment, and at 2-month, 6-month, 1-year and 2-year follow-up)
- MD Anderson Symptom Inventory-Head & Neck score(Week 0 post-treatment, and at 2-month, 6-month, 1-year and 2-year follow-up)
- Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V)(Week 0 post-treatment and at 6-month follow-up)
- Rates of new hypothyroidism(At 2- and 5-year follow-up)
- Rates of acute toxicity as per CTCAE v5.0(Week 0 post-treatment and at 2-month follow-up)
- Rates of chronic toxicity as per CTCAE v5.0(At 6-month, 1-year, 2-year and 5-year post-treatment)
- Rates of cerebrovascular event (transient ischemic attack or stroke)(At 5-year follow-up)