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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adaptive Radiotherapy treatment | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intensity-modulated radiotherapy | Radiation | All patients will be treated with intensity-modulated radiotherapy (IMRT) plans. |
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| Measure | Description | Time Frame |
|---|---|---|
| Improvement in Mean OAR Dose Reduction | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients achieving a complete anatomic response | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ashley Brennaman | Contact | 813-745-5467 | ashley.brennaman@moffitt.org |
| Name | Affiliation | Role |
|---|---|---|
| George Yang, MD | Moffitt Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moffitt Cancer Center | Recruiting | Tampa | Florida | 33612 | United States |
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| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D050397 | Radiotherapy, Intensity-Modulated |
| ID | Term |
|---|---|
| D020266 | Radiotherapy, Conformal |
| D011881 | Radiotherapy, Computer-Assisted |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
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| Magnetic Resonance Guidance | Other | All patients will undergo combined CT and/or MR simulation and will be treated with a sequential-boost technique. |
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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 |
| D018307 |
| Neoplasms, Squamous Cell |
| D009371 | Neoplasms by Site |