SGRT in Head and Neck Cancer Radiotherapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SGRT-guided radiotherapy with open thermoplastic mask immobilization, Closed head-neck-shoulder thermoplastic mask with laser alignment.
- Who it may be relevant to
- Registry conditions: Head and Neck Cancer, Radiotherapy, Conformal (IMRT). Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Prospective, Phase II, Randomized Controlled Study of Surface Guided Radiation Therapy (SGRT) in Head and Neck Cancer Radiotherapy
Overview
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
- Device SGRT-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. - Device Closed 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.
Primary outcome measures
- Six-Dimensional Setup Error [Time frame: First three times and weekly before each fraction during the entire radiotherapy course （typically 5-7 weeks）.]
- Intrafraction Motion [Time frame: First three times and weekly before each fraction during the entire radiotherapy course （typically 5-7 weeks）.]
Secondary outcome measures (3)
- Dosimetric Parameters of Organs at Risk [Time frame: During the entire radiotherapy course （typically 5-7 weeks）.]
- Patient Comfort and Satisfaction [Time frame: Weekly during the entire radiotherapy course （typically 5-7 weeks）.]
- Acute Radiation-Induced Toxicity [Time frame: Weekly during treatment （typically 5-7 weeks) and at 1-month post-treatment follow-up.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Sun Yat-sen Memorial Hospital, Sun Yat-sen University — Guangzhou
Publications
- Wiant D, Squire S, Liu H, Maurer J, Lane Hayes T, Sintay B. A prospective evaluation of open face masks for head and neck radiation therapy. Pract Radiat Oncol. 2016 Nov-Dec;6(6):e259-e267. doi: 10.1016/j.prro.2016.02.003. Epub 2016 Feb 13. PMID 27025164
- Zhao B, Maquilan G, Jiang S, Schwartz DL. Minimal mask immobilization with optical surface guidance for head and neck radiotherapy. J Appl Clin Med Phys. 2018 Jan;19(1):17-24. doi: 10.1002/acm2.12211. Epub 2017 Nov 9. PMID 29119677
- Malone C, Ryan S, Nicholson J, 'Maolalai RO, O'Donovan R, McArdle O, Duane F, Armstrong J, Keenan L, Glynn A, Woods R, McClean B, Brennan S. Intrafraction motion stability of open vs. closed facemasks in head and neck radiotherapy: Insights from the OPEN phase III trial. Radiother Oncol. 2025 Aug;209:110941. doi: 10.1016/j.radonc.2025.110941. Epub 2025 May 21. PMID 40409364
Identifiers
NCT: NCT07726407 · SYSKY-2026-355-01