Head and Neck CancerNCT07726407
SGRT in Head and Neck Cancer Radiotherapy
A study testing SGRT-guided radiotherapy with open thermoplastic mask immobilization and Closed head-neck-shoulder thermoplastic mask with laser alignment in people with Head and Neck Cancer and Radiotherapy, Conformal (IMRT), run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Head and Neck Cancer, Radiotherapy, Conformal (IMRT)
- What is being tested?
- SGRT-guided radiotherapy with open thermoplastic mask immobilization and Closed head-neck-shoulder thermoplastic mask with laser alignment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 15 Jun 2026to 30 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Prior head and neck radiotherapy.
- Brain tumor radiotherapy.
- Non-conventional fractionation radiotherapy (e.g., hypofractionation, hyperfractionation, SBRT) is planned.
- Pregnant or lactating women.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong
Ye ling, Doctor, (020)36997353, 32600972@qq.com
About this study
Official title: A Prospective, Phase II, Randomized Controlled Study of Surface Guided Radiation Therapy (SGRT) in Head and Neck Cancer Radiotherapy
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.
- Being tested
- SGRT-guided radiotherapy with open thermoplastic mask immobilization, Closed head-neck-shoulder thermoplastic mask with laser alignment
- Keywords
- head and neck cancer, optical surface guidance technology, radiotherapy
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SGRT-guided radiotherapy with open thermoplastic mask immobilizationDevice
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.
Closed head-neck-shoulder thermoplastic mask with laser alignmentDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Optical Surface Guidance + Open-Face Mask Group | Experimental | 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. Receives: Device: SGRT-guided radiotherapy with open thermoplastic mask immobilization |
| Conventional Positioning + Closed Mask Group | Active comparator | 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. Receives: Device: Closed head-neck-shoulder thermoplastic mask with laser alignment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: First three times and weekly before each fraction during the entire radiotherapy course （typically 5-7 weeks）.
Intrafraction Motion
Magnitude of patient movement during the delivery of a fraction, detected by real-time SGRT monitoring or post-treatment CBCT.
Measured: First three times and weekly before each fraction during the entire radiotherapy course （typically 5-7 weeks）.
Secondary outcomes (3)
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.
Measured: During the entire radiotherapy course （typically 5-7 weeks）.
Patient Comfort and Satisfaction
Questionnaire scores assessing patient-reported comfort, anxiety, and satisfaction related to mask immobilization.
Measured: Weekly during the entire radiotherapy course （typically 5-7 weeks）.
Acute Radiation-Induced Toxicity
Incidence and severity of skin reactions, mucositis, xerostomia, etc., graded according to CTCAE v5.0.
Measured: Weekly during treatment （typically 5-7 weeks) and at 1-month post-treatment follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2026
- Study start15 Jun 2026
- Primary completion30 Dec 2028 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07726407
- Sponsor's protocol ID
- SYSKY-2026-355-01
- Status last verified
- May 2026
- First submitted
- 28 Jun 2026
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 27025164Zhao 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.
PubMed 29119677Malone 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.
PubMed 40409364
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Phase II, Randomized Controlled Study of Surface Guided Radiation Therapy (SGRT) in Head and Neck Cancer Radiotherapy
- ClinicalTrials.gov ID
- NCT07726407
- Acronym / sponsor ID
- SYSKY-2026-355-01
- Keywords
- head and neck cancer, optical surface guidance technology, radiotherapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 15 Jun 2026 (actual)
- Primary completion
- 30 Dec 2028 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 24 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Optical Surface Guidance + Open-Face Mask Group | Experimental | Device: SGRT-guided radiotherapy with open thermoplastic mask immobilizationPatients 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. |
| Conventional Positioning + Closed Mask Group | Active comparator | Device: Closed head-neck-shoulder thermoplastic mask with laser alignmentPatients 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- Prior head and neck radiotherapy.
- Brain tumor radiotherapy.
- Non-conventional fractionation radiotherapy (e.g., hypofractionation, hyperfractionation, SBRT) is planned.
- Pregnant or lactating women.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SGRT-guided radiotherapy with open thermoplastic mask immobilizationPatients 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 | Optical Surface Guidance + Open-Face Mask Group |
| Closed head-neck-shoulder thermoplastic mask with laser alignmentPatients 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. | Device | Conventional Positioning + Closed Mask Group |
Primary outcome
Six-Dimensional Setup Error
Time frame: 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
Time frame: 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.
3 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- Background: PubMed 27025164Wiant 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.
- Background: PubMed 29119677Zhao 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.
- Background: PubMed 40409364Malone 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SGRT-guided radiotherapy with open thermoplastic mask immobilization and Closed head-neck-shoulder thermoplastic mask with laser alignment in people with Head and Neck Cancer and Radiotherapy, Conformal (IMRT), run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ye ling ((020)36997353, 32600972@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Six-Dimensional Setup Error (time frame: First three times and weekly before each fraction during the entire radiotherapy course （typically 5-7 weeks）.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07726407, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.