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Adaptive Radiotherapy Boost for Head and Neck Cancer

This study is testing if it's possible to use Magnetic Resonance Imaging (MRI) to adjust a part of radiation therapy for people with head and neck squamous cell carcinoma (a type of cancer). All patients will receive intensity-modulated radiotherapy (IMRT), a precise form of radiation. The goal is to personalize your treatment based on how your body responds, while keeping all treatments within standard care guidelines. The study aims to see if this approach can improve how much radiation healthy organs receive. We are looking for 35 participants aged 18 and older with head and neck squamous cell carcinoma. The current recruitment status is unclear.

Study design
This is an interventional study with a planned enrollment of 35 participants. It is not specified if it is randomized or blinded.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 15 months to measure the improvement in mean OAR (Organ At Risk) dose reduction.

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NCT06137274

Phase 2 Trial of Adaptive Radiotherapy Boost for HNSCC

Recruiting
PHASE2Ages 18+InterventionalTreatment
H. Lee Moffitt Cancer Center and Research Institute
~35 participants
Updated 2026-04-01 on ClinicalTrials.gov
What's tested:Intensity-modulated radiotherapyMagnetic Resonance Guidance

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Improvement in Mean OAR Dose Reduction
Measured over Up to 15 months

Conditions

Squamous Cell Carcinoma
Head and Neck Cancer

Explore related trials

Head and Neck Squamous Cell Carcinoma

Where it's being run

1 sites across 1 states
Florida1

Study leadership

  • George Yang, MD · PRINCIPAL_INVESTIGATOR · Moffitt Cancer Center

Who to contact

Ashley Brennaman
[email protected]
813-745-5467
Email the study team

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Eligibility criteria

Inclusion

Provision of signed and dated informed consent form
Stated willingness to comply with all study procedures and availability for the duration of the study
ECOG performance status of 0, 1
Patients with histologically or cytologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, nasopharynx, hypopharynx, larynx, or unknown primary in the neck.
Patients with measurable disease, either at primary site or neck per RECIST 1.1.
For patients planned to receive chemotherapy, adequate hematologic, hepatic and renal function as outlined in protocol.
International normalized ratio of prothrombin time (INR) and prothrombin time (PT) within 28 days before randomization must be WNL for the lab. Patients who are therapeutically treated with an agent such as warfarin may participate if they are on a stable dose and no underlying abnormality in coagulation parameters exists per medical history.
Negative serum pregnancy test within before starting study treatment in woman with childbearing potential.

Exclusion

Pregnancy or lactation
Patients who have had prior radiotherapy to the head and neck or prior systemic therapy for the index cancer.
Patients who had undergone definitive surgery for the index cancer.
Patients with distant metastatic disease
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements.

What this trial measures

  • Improvement in Mean OAR Dose ReductionUp to 15 months

    Feasibility of MR adaptive boost technique, as defined as achieving a reduction of mean OAR (parotids, submandibular glands, pharynx, oral cavity, tubarial glands, larynx, esophagus, and thyroid) doses greater than 7.5% compared to unadapted CT based plan. If 18 of 25 patients are meet the mean OAR criteria the approach will be considered feasible.