Radiation Therapy Plan Quality Improvement Using Ideal Theoretical Isodose Distribution

Head and Neck Neoplasms Clinical Trial

Official title:

Radiation Therapy Plan Quality Improvement Using Ideal Theoretical Isodose Distribution

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04782726
• Other study ID #: CTMS# 20-0114
• Secondary ID: HSC20200678H
• Status: Completed
• Phase: N/A
• Start date: December 16, 2021
• Est. completion date: January 20, 2023

Study information

• Verified date: January 2023
• Source: The University of Texas Health Science Center at San Antonio
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: January 20, 2023
• Est. primary completion date: January 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Head and Neck Neoplasms

Intervention

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.
• Radiation therapy
Standard of Care planning for Radiation therapy is used to treat the subjects for head and neck cancer

Locations

Country	Name	City	State
United States	Mays Cancer Center	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center at San Antonio

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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)