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MRI Linac contract was not renewed at our institution after Viewray went bankrupt. Therefore we cannot do adaptive treatments on this machine. No patients were enrolled.
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The purpose of this research is to determine whether it is feasible to treat patients with Human Papilloma Virus positive (HPV-positive) oropharyngeal tumors on a specialized treatment machine (MRIdian linear accelerator [Linac]), which utilizes magnetic resonance imaging (MRI) for radiation planning and delivery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MRIdian Linac Group | Experimental | All accrued participants will be enrolled onto the MRIdian Linac Group. Participants will receive adaptive radiotherapy (ART) on the MRIdian Linac. Participants will complete the duration of their radiotherapy regimen on the MRIdian Linac for approximately 7 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRIdian Linac | Device | Radiation therapy (RT) will be delivered with an integrated MRI-RT delivery system (MRIdian Linac). Participants will then receive standard-of-care RT with a dose prescription of 70 Gy in 35 fractions on the MRIdian Linac. Adaptive RT (ART) planning will occur every 5th fraction of RT. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent difference between initial reference plan and adaptive weekly RT plan | Weekly adaptive plans will be compared to the initial reference plan and compared using a percent difference equation estimating the actual values of the quantities used as dosimetric constraints for each participant between the initial reference plan and the weekly adaptive plan[s]. | Up to 6 months |
| Evaluation of deformable imaging registration | For evaluation of deformable imaging registration, deformed contours will be compared to the physician-segmented contours using the Dice similarity coefficient (DSC). | Up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment times recorded in minutes | We will follow previously-established guidelines by the MR-Linac Consortium Head and Neck Tumor Site for measuring treatment times. Treatment times will be calculated in minutes from the time stamps in the record and verify system. Three timepoints will be recorded: [1] setup and plan optimization [i.e. time between the participant's arrival to the MRidian and delivery of the first beam]; [2] beam delivery [i.e. the time between delivery of the first and last beam]; and [3] total treatment time. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stuart Samuels, MD, PhD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Miami Sylvester Comprehensive Cancer Center | Miami | Florida | 33136 | United States |
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| ID | Term |
|---|---|
| D009959 | Oropharyngeal Neoplasms |
| ID | Term |
|---|---|
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
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| Up to 6 months |
| Patient-reported Quality of Life as measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ) (EORTC QLQ-C30) | Quality of life will be assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). It consists of 30 items to measure multiple aspects that incorporated five functional scales (physical, role, cognitive, emotional, and social), three symptom scales (fatigue, pain, and nausea/vomiting), a global health status/QoL scale, and six single common items (dyspnea, loss of appetite, insomnia, constipation, diarrhea, and financial difficulties). The scoring system ranged from 1 (not at all) to 4 (very much). High scores for functional items and low scores for symptoms represent the good QoL.There are two questions for the overall quality of life rating, and the ranking ranged from 1 (very poor) to 7 (excellent). | Up to 1 year |
| Patient-reported Quality of Life as measured by the European Organization for Research and Treatment Head & Neck 43 | Quality of life will be assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-H&N43). The questionnaire used will be for that for head and neck patients, score range from 1 (not at all) to 4 (very much), higher scores indicate lower quality of life. | Up to 1 year |
| D009369 | Neoplasms |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |