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

NCT ID: NCT07227792

Last Updated: 2025-11-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-30
• Study Completion Date: 2029-01-31

Brief 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.

Detailed Description

Despite good disease control and organ preservation outcomes after radiotherapy (RT) for head and neck cancers (HNC), particularly human papillomavirus (HPV)-related oropharyngeal cancer, treatment-related toxicities remain a challenging survivorship problem. Impaired calorie intake due to common RT-associated toxicities such as mucositis, dysphagia (difficulty swallowing), and dysgeusia (taste loss) can lead to treatment breaks that reduce treatment efficacy and prolong recovery, some of which persist long-term and negatively impact quality of life (QOL). Radiation doses to the pharyngeal constrictor muscles (PCM) and oral tongue correlate with incidence and severity of dysphagia and dysgeusia. Doses to the pharyngeal and oral tongue mucosa are associated with incidence and severity of mucositis. "Tongue-out" radiation therapy (TORT) is 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. TORT for oropharyngeal, laryngeal, and hypopharyngeal cancers may result in significantly lower radiation dose to the PCM and oral tongue compared to "tongue-in" RT, and that this reduced dose to organs at risk (OARs) will yield clinically meaningful improvements in severity and duration of dysphagia, dysgeusia, and mucositis.

Conditions

Head and Neck Carcinoma

Keywords

Tongue-out radiation therapy (TORT); human papillomavirus (HPV)-related oropharyngeal cancer; Intensity modulated radiotherapy (IMRT); volumetric modulated arc therapy (VMAT)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Tongue-out radiation therapy (TORT)

Intervention Type: 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.

Interventions

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.

Intervention Type: RADIATION

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Radiological Society of North America

OTHER

Sponsor Role: collaborator

Yvonne Mowery

OTHER

Sponsor Role: lead

Responsible Party

Yvonne Mowery

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Yvonne Mowery, MD

Role: PRINCIPAL_INVESTIGATOR

UPMC Hillman Cancer Center

Locations

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

Countries

United States

Central Contacts

Samantha Demko, RN

Role: CONTACT

Phone: 412-623-1400

Email: albesl@upmc.edu

Brieanna Marino, MS

Role: CONTACT

Phone: 4126478258

Email: rowlesbm@upmc.edu

Facility Contacts

Samantha Demko, RN

Role: primary

Brieanna Marino, MS

Role: backup

Other Identifiers

HCC 25-085

Identifier Type: -

Identifier Source: org_study_id