SGRT in Head and Neck Cancer Radiotherapy

July 22, 2026 updated by: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China
        • Recruiting
        • Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Optical Surface Guidance + Open-Face Mask Group
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
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.
Active Comparator: Conventional Positioning + Closed Mask Group
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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）.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dosimetric Parameters of Organs at Risk
Time Frame: During the entire radiotherapy course （typically 5-7 weeks）.
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.
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）.
Questionnaire scores assessing patient-reported comfort, anxiety, and satisfaction related to mask immobilization.
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.
Incidence and severity of skin reactions, mucositis, xerostomia, etc., graded according to CTCAE v5.0.
Weekly during treatment （typically 5-7 weeks) and at 1-month post-treatment follow-up.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2026

Primary Completion (Estimated)

December 30, 2028

Study Completion (Estimated)

December 30, 2028

Study Registration Dates

First Submitted

June 28, 2026

First Submitted That Met QC Criteria

July 22, 2026

First Posted (Actual)

July 24, 2026

Study Record Updates

Last Update Posted (Actual)

July 24, 2026

Last Update Submitted That Met QC Criteria

July 22, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SYSKY-2026-355-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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