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New treatment option for Head and Neck Carcinoma
Official title Tongue-out Radiation Therapy (TORT) for the Mitigation of Radiotherapy-related Toxicities in Patients With Head and Neck Cancer
ClinicalTrials.gov ID: NCT07227792
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Must have histologically or cytologically confirmed squamous cell carcinoma of the oropharynx, larynx, or hypopharynx (cT0-4, N0-3, M0-1).
- 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)
You likely can't join if
- Patients with T1-T2 N0 glottic cancer (i.e., planned to undergo RT to the larynx only)
- Posterior pharyngeal wall primary tumor
- Widely metastatic disease
- Surgical resection of the primary tumor
- Induction chemotherapy or immunotherapy prior to planned radiotherapy
- Prior head and neck radiotherapy
See the full eligibility criteria
- Must have histologically or cytologically confirmed squamous cell carcinoma of the oropharynx, larynx, or hypopharynx (cT0-4, N0-3, M0-1).
- 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)
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2
- Female people of childbearing potential must not be pregnant or breastfeeding at screening.
- Female people 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...
- Female people 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...
- Must be able to comfortably protrude tongue in the treatment position for at least 1 minute.
- Must have the ability to understand and the willingness to sign a written informed consent document.
- Must be willing to comply with all study procedures.
- Must be able to complete patient-reported outcome (PRO) questionnaires in English.
- Patients with T1-T2 N0 glottic cancer (i.e., planned to undergo RT to the larynx only)
- Posterior pharyngeal wall primary tumor
- Widely metastatic disease
- Surgical resection of the primary tumor
- Induction chemotherapy or immunotherapy prior to planned radiotherapy
- Prior head and neck radiotherapy
The study team makes the final eligibility decision.
Where it's taking place
- Pittsburgh, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Pittsburgh, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.