Personalized radiation therapy for head and neck cancer
Phase 2 Trial of Adaptive Radiotherapy Boost for Head and Neck Squamous Cell Carcinomas
This study is testing whether using MRI to tailor radiation therapy can improve treatment for people with head and neck cancer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 35 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | H. Lee Moffitt Cancer Center and Research Institute Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Tampa, Florida) |
| Trial ID | NCT06137274 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include patients with confirmed squamous cell carcinoma of the head and neck who are willing to comply with study procedures.
Not a fit: Patients with non-squamous cell carcinoma or those who do not meet the eligibility criteria may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Tampa, Florida
- Moffitt Cancer Center — Tampa, Florida, United States (Recruiting)
Study contacts
- Principal investigator: George Yang, MD — Moffitt Cancer Center
- Study coordinator: Ashley Brennaman
- Email: ashley.brennaman@moffitt.org
- Phone: 813-745-5467
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.