Clinical trial · Interventional
SGRT in Head and Neck Cancer Radiotherapy
A Prospective, Phase II, Randomized Controlled Study of Surface Guided Radiation Therapy (SGRT) in Head and Neck Cancer Radiotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Radiotherapy, Conformal (IMRT) | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Closed head-neck-shoulder thermoplastic mask with laser alignment | Device | — | UNRESOLVED |
| SGRT-guided radiotherapy with open thermoplastic mask immobilization | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Optical Surface Guidance + Open-Face Mask Group
- description
- 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.
- interventionNames
- Device: SGRT-guided radiotherapy with open thermoplastic mask immobilization
- type
- ACTIVE_COMPARATOR
- label
- Conventional Positioning + Closed Mask Group
- description
- 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.
- interventionNames
- Device: Closed head-neck-shoulder thermoplastic mask with laser alignment
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (3)
- BACKGROUNDWiant 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
- BACKGROUNDZhao 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
- BACKGROUNDMalone 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