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NCT Number: NCT07726407

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Guangzhou, Guangdong, China

Location status: Recruiting

Location contact

Ye ling, Doctor

CONTACT

[email protected]

(020)36997353

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

A Prospective, Phase II, Randomized Controlled Study of Surface Guided Radiation Therapy (SGRT) in Head and Neck Cancer Radiotherapy

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jul 24, 2026
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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