Radiation Therapy Plan Quality Improvement Using Ideal Theoretical Isodose Distribution

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.

Study Overview

• Status: Completed
• Conditions: Head and Neck Neoplasms
• Intervention / Treatment: Other: Radiation therapy; Other: Software Solution for Radiation Therapy 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.

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78229
      • Mays Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control Arm; 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.	Other: Radiation therapy; Standard of Care planning for Radiation therapy is used to treat the subjects for head and neck cancer; Other Names: Radiation treatment
Experimental: Research Arm; 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.	Other: Radiation therapy; Standard of Care planning for Radiation therapy is used to treat the subjects for head and neck cancer; Other Names: Radiation treatment; Other: Software Solution for Radiation Therapy Treatment; Software has been developed for individualized pre optimization evaluation of the patient anatomy and prescribed dose of radiation therapy.; Other Names: Treatment planning

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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)

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center at San Antonio
• Investigators: Principal Investigator: Sotirios Stathakis, PhD, UT Health San Antonio

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2021
• Primary Completion (Actual): January 20, 2023
• Study Completion (Actual): January 20, 2023

Study Registration Dates

• First Submitted: March 1, 2021
• First Submitted That Met QC Criteria: March 1, 2021
• First Posted (Actual): March 4, 2021

Study Record Updates

• Last Update Posted (Estimate): January 24, 2023
• Last Update Submitted That Met QC Criteria: January 20, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: CTMS# 20-0114; HSC20200678H (Other Identifier: UT Health Science Center San Antonio IRB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No