Phase 2 Trial of Adaptive Radiotherapy Boost for HNSCC

March 31, 2026 updated by: H. Lee Moffitt Cancer Center and Research Institute

Phase 2 Trial of Adaptive Radiotherapy Boost for Head and Neck Squamous Cell Carcinomas

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

35

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Florida
      • Tampa, Florida, United States, 33612
        • Recruiting
        • Moffitt Cancer Center
        • Principal Investigator:
          • George Yang, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Radiation: Intensity-modulated radiotherapy
All patients will be treated with intensity-modulated radiotherapy (IMRT) plans.
Other Names:
  • IMRT
Other: Magnetic Resonance Guidance
All patients will undergo combined CT and/or MR simulation and will be treated with a sequential-boost technique.
Other Names:
  • View Ray

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement in Mean OAR Dose Reduction
Time Frame: Up 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.
Up to 15 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of patients achieving a complete anatomic response
Time Frame: Up to 15 months
Percentage of patients achieving a complete anatomic response by CT Neck and Chest and/or PET/CT will be tabulated. The 95% CI by the exact binomial distribution will be reported.
Up to 15 months
Percentage of patients achieving a complete metabolic response
Time Frame: Up to 15 months
Percentage of patients achieving a complete metabolic response by CT Neck and Chest and/or PET/CT will be tabulated. The 95% CI by the exact binomial distribution will be reported.
Up to 15 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Investigators

  • Principal Investigator: George Yang, MD, Moffitt Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 14, 2023

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

November 13, 2023

First Submitted That Met QC Criteria

November 13, 2023

First Posted (Actual)

November 18, 2023

Study Record Updates

Last Update Posted (Actual)

April 1, 2026

Last Update Submitted That Met QC Criteria

March 31, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCC-22313

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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