A Prospective, Phase II, Randomized Controlled Study of Surface Guided Radiation Therapy (SGRT) in Head and Neck Cancer Radiotherapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Six-Dimensional Setup Error
研究概览
简要总结
This study is a prospective, randomized, open-label, single-center exploratory trial. A total of 40 newly diagnosed, untreated head and neck cancer patients （stage I-IVa, AJCC 8th edition） will be enrolled and randomly assigned in a 1：1 ratio to either the experimental group or the control group. The experimental group will receive radiotherapy immobilization using optical surface guidance technology combined with an open-face mask, while the control group will undergo conventional positioning with a closed head-neck-shoulder thermoplastic mask. The primary objective is to compare the six-dimensional setup errors derived from cone-beam CT （CBCT） registration and intrafraction motion between the two groups. The secondary objective is to compare dosimetric parameters of organs at risk （including lens, eyeball, spinal cord, brainstem, temporal lobe, parotid gland, submandibular gland, thyroid gland, mandible, and temporomandibular joint） between the two groups. The safety of the optical surface-guided open-face mask technique will be evaluated by monitoring radiotherapy-related adverse effects during and after treatment. This study aims to investigate whether optical surface guidance combined with open-face immobilization can improve patient comfort, provide more precise radiotherapy, and enhance the protection of normal tissues.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years, <75 years.
- •Histologically or cytologically confirmed head and neck malignant tumors （including nasopharynx, oropharynx, larynx, hypopharynx, oral cavity, etc.）.
- •Stage T1-4, N0-3, M0 （Stage I-IVa） according to AJCC 8th edition.
- •Planned to receive radical radiotherapy （with or without concurrent chemotherapy/ targeted therapy）.
- •Ability to tolerate breath-hold ≥ 30 seconds and to complete necessary couch shifts for patient positioning during a single breath-hold.
排除标准
- •Prior head and neck radiotherapy.
- •Brain tumor radiotherapy.
- •Non-conventional fractionation radiotherapy (e.g., hypofractionation, hyperfractionation, SBRT) is planned.
- •Pregnant or lactating women.
结局指标
主要结局
Six-Dimensional Setup Error
时间窗: First three times and weekly before each fraction during the entire radiotherapy course （typically 5-7 weeks）.
Translational errors （X, Y, Z in mm） and rotational errors （Rx, Ry, Rz in degrees） measured via CBCT bone-window registration to planning CT.
Intrafraction Motion
时间窗: First three times and weekly before each fraction during the entire radiotherapy course （typically 5-7 weeks）.
Magnitude of patient movement during the delivery of a fraction, detected by real-time SGRT monitoring or post-treatment CBCT.
次要结局
- Dosimetric Parameters of Organs at Risk(During the entire radiotherapy course （typically 5-7 weeks）.)
- Patient Comfort and Satisfaction(Weekly during the entire radiotherapy course （typically 5-7 weeks）.)
- Acute Radiation-Induced Toxicity(Weekly during treatment （typically 5-7 weeks) and at 1-month post-treatment follow-up.)