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RECRUITING

NCT07227792

Tongue-out Radiation Therapy (TORT) for the Mitigation of Radiotherapy-related Toxicities in Patients With Head and Neck Cancer

Sponsor: Yvonne Mowery

View on ClinicalTrials.gov

Summary

Our institution recently began incorporating a novel "tongue-out" radiation therapy (TORT) technique for patients with head and neck tumors at particular subsites (oropharynx, larynx, hypopharynx). Protruding the tongue, i.e. "tongue-out" position, induces anatomical changes that facilitate decreased radiation dose to the oral tongue and PCM. The long-term goal is to determine whether TORT results in reduced severity and faster recovery from acute treatment-related toxicities (particularly mucositis, dysphagia, and dysgeusia) and improved long-term swallowing function and taste compared to traditional "tongue-in" RT for patients with HNC.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-11-23

Completion Date

2029-01-31

Last Updated

2025-12-17

Healthy Volunteers

Conditions

Head and Neck Carcinoma

Interventions

RADIATION

Tongue-out radiation therapy (TORT)

The high-risk PTV will contain the primary tumor and any lymph nodes confirmed or suspected to harbor metastatic disease based on imaging findings, pathology reports, and/or clinical exam. Dose to the high-risk PTV must be 70.0 Gy at 2.0 Gy per fraction. The intermediate-risk PTV will contain areas considered to contain potential microscopic disease in close proximity to the primary tumor (GTV + 10 mm with adjustments per above based on anatomic boundaries or air) and the entire cervical lymph node level(s) corresponding to any lymph nodes confirmed or suspected to harbor metastatic disease. Dose to intermediate-risk PTV must be 63 Gy at 1.8 Gy per fraction. The low-risk PTV will contain any cervical lymph node levels felt to be potentially harbor microscopic disease but with negative imaging and/or clinical findings. The exact cervical lymph node levels included in the low-risk PTV should be based on Tables 3-5. Dose to the low-risk PTV must be 56 Gy at 1.6 Gy per fraction.

Inclusion Criteria: 1. Must have histologically or cytologically confirmed squamous cell carcinoma of the oropharynx, larynx, or hypopharynx (cT0-4, N0-3, M0-1). 2. Patients with metastatic disease will be included if the following criteria are met: * Definitive RT dose is planned for the primary site * The number of metastatic lesions is ≤5 * All metastatic lesions are confined to a single organ (e.g., lung) 3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2 4. Female subjects of childbearing potential must not be pregnant or breastfeeding at screening. * Female subjects are considered to be of childbearing potential unless one of the following criteria is met: o Permanent sterilization (hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or documented postmenopausal status (defined as 12 months of amenorrhea in a woman \> 45 years-of-age in the absence of other biological or physiological causes. Note: Documentation may include review of medical records, medical examination, or medical history interview by study site staff. * Female subjects of childbearing potential must utilize an appropriate method of birth control such as hormonal methods (oral, injectable, implant, skin patch, vaginal ring), intrauterine devices, barrier methods (consistent use of male/female condoms, diaphragms, cervical caps), surgical methods (vasectomy, tubal ligation), or true abstinence. 5. Must be able to comfortably protrude tongue in the treatment position for at least 1 minute. 6. Must have the ability to understand and the willingness to sign a written informed consent document. 7. Must be willing to comply with all study procedures. 8. Must be able to complete patient-reported outcome (PRO) questionnaires in English. Exclusion Criteria: 1. Patients with T1-T2 N0 glottic cancer (i.e., planned to undergo RT to the larynx only) 2. Posterior pharyngeal wall primary tumor 3. Widely metastatic disease 4. Surgical resection of the primary tumor 5. Induction chemotherapy or immunotherapy prior to planned radiotherapy 6. Prior head and neck radiotherapy

Locations (1)

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, United States