SGRT in Head and Neck Cancer Radiotherapy
Recruiting now · Not applicable
Conditions studied: Head and Neck Cancer, Radiotherapy, Conformal (IMRT)
In brief
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.
Key facts
- Study ID
- NCT07726407
- Run by
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- People needed
- 40
- Starts
- 2026-06-15
- Expected to finish
- 2028-12-30
- Last updated by the study team
- 2026-07-24
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- Prior head and neck radiotherapy.
- Brain tumor radiotherapy.
- Non-conventional fractionation radiotherapy (e.g., hypofractionation, hyperfractionation, SBRT) is planned.
- Pregnant or lactating women.
Where it is running
- Sun Yat-sen Memorial Hospital, Sun Yat-sen University — Guangzhou, Guangdong, China (enrolling)
Full record on ClinicalTrials.gov
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