Clinical trial Recruiting at 1 site Phase 2 Interventional Ages 18 and up

Personalized radiation therapy for head and neck cancer

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

Run by H. Lee Moffitt Cancer Center and Research Institute · NCT06137274 · Data updated 2026-11-12

This study is testing whether using MRI to tailor radiation therapy can improve treatment for people with head and neck cancer.

Quick facts

PhasePhase 2
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment35 (estimated)
SponsorH. Lee Moffitt Cancer Center and Research Institute
Academic / other
Drugs / interventionschemotherapy, radiation
Locations1 site (Tampa, Florida)
StatusRecruiting
StartedDecember 14, 2023
Main results expectedMay 2027
Study endsMay 2027
Registry record updatedApril 1, 2026
Trial IDNCT06137274 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include patients with confirmed squamous cell carcinoma of the head and neck who are willing to comply with study procedures.

Probably not a fit

Patients with non-squamous cell carcinoma or those who do not meet the eligibility criteria may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the feasibility of using magnetic resonance imaging (MRI) to adapt radiation therapy for patients with head and neck squamous cell carcinoma. By personalizing treatment based on individual responses, the study seeks to optimize radiation delivery while adhering to standard care guidelines. The intervention involves intensity-modulated radiotherapy guided by MRI to enhance treatment effectiveness.

Why it matters

Potential benefit: If successful, this approach could lead to more effective and tailored radiation treatments for patients with head and neck cancer.

How similar studies have gone: While the use of MRI in radiation therapy is an emerging field, similar adaptive approaches have shown promise in other cancer types, indicating potential for success in this study.

Who can join: the full rules

Show full inclusion / exclusion criteria
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.

Where it's running

  • Moffitt Cancer Center
    Tampa, Florida, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.