SGRT in Head and Neck Cancer Radiotherapy

NCT07726407 | Recruiting

• 1 other identifier: SYSKY-2026-355-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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

Head and Neck Cancer; Radiotherapy, Conformal (IMRT)

Keywords

head and neck cancer; optical surface guidance technology; radiotherapy

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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

  During the entire radiotherapy course （typically 5-7 weeks）.

• Patient Comfort and Satisfaction

  Weekly during the entire radiotherapy course （typically 5-7 weeks）.

• Acute Radiation-Induced Toxicity

  Weekly during treatment （typically 5-7 weeks) and at 1-month post-treatment follow-up.

Study Arms (2)

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.

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.

Device: Closed head-neck-shoulder thermoplastic mask with laser alignment

Interventions

SGRT-guided radiotherapy with open thermoplastic mask immobilization DEVICE

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.

Optical Surface Guidance + Open-Face Mask Group

Closed head-neck-shoulder thermoplastic mask with laser alignment DEVICE

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.

Conventional Positioning + Closed Mask Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

Study Sites (1)

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

RECRUITING

Related Publications (3)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Central Study Contacts

Ye ling

CONTACT

(020)36997353; 32600972@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2026
• First Posted: July 24, 2026
• Study Start: June 15, 2026
• Primary Completion (Estimated): December 30, 2028
• Study Completion (Estimated): December 30, 2028
• Last Updated: July 24, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)