Head and Neck Cancer, Squamous Cell Carcinoma
Conditions
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.
Interventions
RADIATIONIntensity-modulated radiotherapy
All patients will be treated with intensity-modulated radiotherapy (IMRT) plans.
OTHERMagnetic Resonance Guidance
All patients will undergo combined CT and/or MR simulation and will be treated with a sequential-boost technique.
Sponsors
H. Lee Moffitt Cancer Center and Research Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in Mean OAR Dose Reduction | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients achieving a complete anatomic response | 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. |
| Percentage of patients achieving a complete metabolic response | 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. |
Countries
United States
Contacts
CONTACTAshley Brennaman
PRINCIPAL_INVESTIGATORGeorge Yang, MD
Moffitt Cancer Center
Outcome results
None listed