Radiation Therapy Plan Quality Improvement Using Ideal Theoretical Isodose Distribution

The University of Texas System (UT)

Status: Completed

Conditions: Head and Neck Neoplasms

Treatments: Other: Radiation therapy; Other: Software Solution for Radiation Therapy Treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT04782726

HSC20200678H (Other Identifier)

CTMS# 20-0114

Details and patient eligibility

About

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.

Full 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.

Enrollment: 21 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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21 participants in 2 patient groups, including a placebo group

Control Arm

Placebo Comparator group

Description:

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.

Treatment:

Other: Radiation therapy

Research Arm

Experimental group

Description:

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.

Treatment:

Other: Software Solution for Radiation Therapy Treatment

Other: Radiation therapy