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

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
Yvonne Mowery
Study ID
NCT07227792
Status
Recruiting
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Conditions

  • Head and Neck Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tongue-out radiation therapy (TORT) — RADIATION
    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.

Study Details

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 Dates

Start date
Nov 23, 2025
Status verified
Dec 2025
Primary completion
Nov 30, 2027
Completion
Jan 31, 2029

Study Design

Enrollment
35 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Tongue-out radiation therapy (TORT)
    A treatment positioning technique for patients with head and neck tumors at particular subsites (e.g., oropharynx, larynx, hypopharynx). Protruding the tongue, i.e. "tongue-out" position, during pre-treatment simulation and subsequent treatment induces anatomical changes that facilitate decreased radiation dose to the oral tongue and PCM. All patients will be treated with IMRT. All IMRT techniques, including static field IMRT, helical IMRT (Tomotherapy), and VMAT are allowed.

Primary Outcome Measure

Eating Assessment Tool 10 (EAT-10) [ Time Frame: At Baseline ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UPMC Hillman Cancer CenterPittsburghPennsylvania15232
Samantha Demko, RN
[email protected]
412-623-1400
Brieanna Marino, MS
[email protected]
4126478258
Yvonne Mowery, MD (PRINCIPAL_INVESTIGATOR)

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By research site
UPMC Hillman Cancer Center· Pittsburgh, PA

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