Optical surface guidance for head and neck radiotherapy with open-face mask
Official title: A Prospective, Phase II, Randomized Controlled Study of Surface Guided Radiation Therapy (SGRT) in Head and Neck Cancer Radiotherapy
Run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · NCT07726407 · Data updated 2026-11-12
This trial tests whether using optical surface guidance with an open-face mask during radiotherapy for head and neck cancer improves positioning and reduces movement compared with the standard closed mask approach.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Guangzhou, Guangdong) |
| Status | Recruiting |
| Started | June 15, 2026 |
| Main results expected | December 30, 2028 |
| Study ends | December 30, 2028 |
| Registry record updated | July 24, 2026 |
| Trial ID | NCT07726407 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 to under 75 with newly diagnosed, untreated head and neck cancer (Stage I–IVa) planned for radical radiotherapy.
✕Probably not a fit
Patients not experiencing improved immobilization or dosimetric advantage with SGRT may not receive added benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
In this prospective, randomized study, 40 adults with newly diagnosed head and neck cancer will be assigned to either SGRT-guided radiotherapy with an open-face mask or conventional positioning with a closed mask. Outcomes will compare six-dimensional setup errors from CBCT and intrafraction motion between groups, as well as dosimetric parameters for nearby organs at risk. The trial aims to determine if the optical surface guidance approach can improve treatment accuracy and potentially spare normal tissues. Safety and tolerability of the SGRT approach will also be monitored. Enrollment is at a single center in Guangzhou, China.
Why it matters
Potential benefit: If successful, SGRT with an open-face mask could improve treatment accuracy and potentially reduce radiation exposure to surrounding healthy tissues.
How similar studies have gone: Previous studies in radiotherapy immobilization have shown promise for SGRT approaches, but this exact open-face mask configuration with HB IMRT is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China Recruiting
Study contacts
- Study coordinator: Ye ling
- Email: 32600972@qq.com
- Phone: (020)36997353
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.