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| ID | Type | Description | Link |
|---|---|---|---|
| HSC20200678H | Other Identifier | UT Health Science Center San Antonio IRB |
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The researchers hope that based on the study findings future patients may benefit from a more precise radiation treatment plan that can be developed more quickly and thus decrease the time from Computerized Tomography Simulation to start of treatment.
As part of this study participants will receive the standard of care treatment for all head and neck cancer patients. The researchers plan to use a software program to see if it will assist in developing the best radiation treatment plan possible. The researchers will also measure the quality of each treatment plan so areas of improvement can be identified.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Arm | Placebo Comparator | After consent and study enrollment the subject will be scheduled for CT simulation for radiation treatment planning. At the time of CT simulation, they will be immobilized by means of a thermoplastic mask. For patients in the control arm, the radiation treatment planning will proceed as normal. Treatment planning is performed on Pinnacle. The patient will return for validation of the radiation plan. Validation involves collecting on-table X-rays or cone beam CTs when the patient is in position for treatment, which is the standard of care. Most often, the date of validation will happen within 5 business days of the CT simulation. |
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| Research Arm | Experimental | After consent and study enrollment the subject will be scheduled for CT simulation for radiation treatment planning. At the time of CT simulation, they will be immobilized by means of a thermoplastic mask. For patients in the research arm, a theoretical plan will be created after physician's segmentation and will be used as a guide for the final plan. The patient will return for validation of the radiation plan. Validation involves collecting on-table X-rays or cone beam CTs when the patient is in position for treatment, which is the standard of care. Most often, the date of validation will happen within 5 business days of the CT simulation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Software Solution for Radiation Therapy Treatment | Other | Software has been developed for individualized pre optimization evaluation of the patient anatomy and prescribed dose of radiation therapy. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean radiation dose to Organs at Risk (OAR) | Measurement of radiation dose to organs at risk. The goal is to maintain the PTV (Planning Target Volume) coverage while minimizing the dose to organs at risk (OARs). | Baseline to last treatment (up to 33 treatments or about 7 weeks) |
| Maximum radiation dose to Organs at Risk (OAR) | Measurement of maximum radiation dose to organs at risk. The goal is to maintain the PTV (Planning Target Volume) coverage while minimizing the dose to organs at risk (OARs). | Baseline to last treatment (up to 33 treatments or about 7 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Time required to plan radiation therapy dose | The time required with and without individualized pre optimization information will be recorded and compared to determine efficiency. | CT Simulation to first treatment (about 1 week) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sotirios Stathakis, PhD | The University of Texas Health Science Center at San Antonio | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mays Cancer Center | San Antonio | Texas | 78229 | United States |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Radiation therapy | Other | Standard of Care planning for Radiation therapy is used to treat the subjects for head and neck cancer |
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