SGRT in Head and Neck Cancer Radiotherapy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSun Yat-Sen Memorial Hospital of Sun Yat-Sen University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years, <75 years.
Histologically or cytologically confirmed head and neck malignant tumors （including nasopharynx, oropharynx, larynx, hypopharynx, oral cavity, etc.）.
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.
Disqualifiers
Prior head and neck radiotherapy.
Brain tumor radiotherapy.
Non-conventional fractionation radiotherapy (e.g., hypofractionation, hyperfractionation, SBRT) is planned.
Pregnant or lactating women.
Trial design
Design model
Parallel
Treatments tested in this trial
SGRT-guided radiotherapy with open thermoplastic mask immobilization
DevicePatients 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.
Closed head-neck-shoulder thermoplastic mask with laser alignment
DevicePatients 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.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Optical Surface Guidance + Open-Face Mask GroupExperimental treatment 1 intervention
Group B: Conventional Positioning + Closed Mask GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Six-Dimensional Setup Error
Translational errors （X, Y, Z in mm） and rotational errors （Rx, Ry, Rz in degrees） measured via CBCT bone-window registration to planning CT.
Time frame
First three times and weekly before each fraction during the entire radiotherapy course （typically 5-7 weeks）.2
Intrafraction Motion
Magnitude of patient movement during the delivery of a fraction, detected by real-time SGRT monitoring or post-treatment CBCT.
Time frame
First three times and weekly before each fraction during the entire radiotherapy course （typically 5-7 weeks）.Secondary outcomes
1
Dosimetric Parameters of Organs at Risk
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.
Time frame
During the entire radiotherapy course （typically 5-7 weeks）.2
Patient Comfort and Satisfaction
Questionnaire scores assessing patient-reported comfort, anxiety, and satisfaction related to mask immobilization.
Time frame
Weekly during the entire radiotherapy course （typically 5-7 weeks）.3
Acute Radiation-Induced Toxicity
Incidence and severity of skin reactions, mucositis, xerostomia, etc., graded according to CTCAE v5.0.
Time frame
Weekly during treatment （typically 5-7 weeks) and at 1-month post-treatment follow-up.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov