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Radiation Therapy Plan Quality Improvement Using Ideal Theoretical Isodose Distribution

Not Applicable
Completed
Conditions
Head and Neck Neoplasms
Interventions
Other: Software Solution for Radiation Therapy Treatment
Other: Radiation therapy
Registration Number
NCT04782726
Lead Sponsor
The University of Texas Health Science Center at San Antonio
Brief Summary

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.

Detailed Description

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
21
Inclusion Criteria
  • Age ≥ 18 years.
  • Ability to provide informed written consent in either English or Spanish.
  • Patient planned to undergo radiation therapy for Head and Neck Cancer.
Exclusion Criteria
  • Current pregnancy, as this is a contraindication to receiving radiation therapy.
  • History of prior radiotherapy to the head and neck.
  • Any condition or history as evidenced by patient record and/or self-report that, in the opinion of the investigator, would interfere with adherence to daily radiation therapy.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Research ArmRadiation therapyAfter 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.
Control ArmRadiation therapyAfter 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.
Research ArmSoftware Solution for Radiation Therapy TreatmentAfter 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.
Primary Outcome Measures
NameTimeMethod
Mean radiation dose to Organs at Risk (OAR)Baseline to last treatment (up to 33 treatments or about 7 weeks)

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).

Maximum radiation dose to Organs at Risk (OAR)Baseline to last treatment (up to 33 treatments or about 7 weeks)

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).

Secondary Outcome Measures
NameTimeMethod
Time required to plan radiation therapy doseCT Simulation to first treatment (about 1 week)

The time required with and without individualized pre optimization information will be recorded and compared to determine efficiency.

Trial Locations

Locations (1)

Mays Cancer Center

🇺🇸

San Antonio, Texas, United States

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