Recruiting
Phase 2

Adaptive Radiotherapy

Sponsor:

H. Lee Moffitt Cancer Center and Research Institute

Code:

NCT06137274

Conditions

Squamous Cell Carcinoma

Head and Neck Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Intensity-modulated radiotherapy

Magnetic Resonance Guidance

Study Details

Brief summary:

The purpose of the study is to determine if it is feasible to use magnetic resonance imaging (MRI) to adjust a portion of radiation therapy for patients with head and neck squamous cell carcinoma . The technique under study will be used to personalize the study treatment based on response, keeping all treatments within standard of care guidelines.

Conditions

Squamous Cell Carcinoma

Head and Neck Cancer

Study ID

NCT06137274

Start date

Dec 14, 2023

Status verified date

Mar, 2026

Completion date

May, 2027

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Study Design

Enrollment

35 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Adaptive Radiotherapy treatment

Patients will undergo adaptive radiotherapy boost for head/neck squamous cell carcinomas. A base conventional IMRT plan of 46-50Gy in 2 Gy to gross disease in the primary/nodes and 41.4-45 Gy in 1.8 Gy to the elective nodes per fraction will be utilized. The MR simulation will be utilized for boost treatment planning. Patients will receive their 6th fraction of the week on the adaptive platform treating the gross disease until completion of the base plan to 20 Gy in 2Gy daily fractions (10 fractions). Each ART treatment will be recontoured/replanned by the treating head/neck radiation oncologist as deemed clinically or dosimetrically necessary.

Interventions

Intensity-modulated radiotherapy

All patients will be treated with intensity-modulated radiotherapy (IMRT) plans.

Magnetic Resonance Guidance

All patients will undergo combined CT and/or MR simulation and will be treated with a sequential-boost technique.

Primary outcome measure

  • Improvement in Mean OAR Dose Reduction [ Time Frame: Up to 15 months ]

Central Contacts and Locations

Central contacts

Ashley Brennaman

813-745-5467ashley.brennaman@moffitt.org

Locations

Moffitt Cancer Center

Recruiting

Tampa, Florida, United States, 33612

Principal Investigator:

George Yang, MD

More Information

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Last update posted

Apr 1, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by H. Lee Moffitt Cancer Center and Research Institute on 2026-04-01.