Head and Neck Cancer, Radiotherapy, Conformal (IMRT)
Conditions
Keywords
head and neck cancer, optical surface guidance technology, radiotherapy
Brief summary
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.
Interventions
DEVICESGRT-guided radiotherapy with open thermoplastic mask immobilization
Patients undergo simulation and treatment using an open-face head-neck-shoulder thermoplastic mask. Before and during each fraction, the surface-guided system monitors the patient's surface position in real-time. Positioning is adjusted based on SGRT data and verified by pre-treatment CBCT.
DEVICEClosed head-neck-shoulder thermoplastic mask with laser alignment
Patients undergo simulation and treatment using a standard closed head-neck-shoulder thermoplastic mask. Positioning is performed using traditional laser marks and skin tattoos, with position verified by pre-treatment CBCT. No optical surface system is used for active monitoring.
Sponsors
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* Prior head and neck radiotherapy. * Brain tumor radiotherapy. * Non-conventional fractionation radiotherapy (e.g., hypofractionation, hyperfractionation, SBRT) is planned. * Pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Six-Dimensional Setup Error | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dosimetric Parameters of Organs at Risk | During the entire radiotherapy course （typically 5-7 weeks）. | Dose-volume histogram metrics （e.g., Dmean, Dmax, D2%, V30） for specified OARs including spinal cord, brainstem, parotids, mandible, etc., derived from the treatment planning system. |
| Patient Comfort and Satisfaction | Weekly during the entire radiotherapy course （typically 5-7 weeks）. | Questionnaire scores assessing patient-reported comfort, anxiety, and satisfaction related to mask immobilization. |
| Acute Radiation-Induced Toxicity | Weekly during treatment （typically 5-7 weeks) and at 1-month post-treatment follow-up. | Incidence and severity of skin reactions, mucositis, xerostomia, etc., graded according to CTCAE v5.0. |
Countries
China
Contacts
CONTACTYe ling
Outcome results
None listed