search
Back to results

Radiation Therapy Plan Quality Improvement Using Ideal Theoretical Isodose Distribution

Primary Purpose

Head and Neck Neoplasms

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Software Solution for Radiation Therapy Treatment
Radiation therapy
Sponsored by
The University of Texas Health Science Center at San Antonio
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Mays Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Control Arm

Research Arm

Arm 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.

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.

Outcomes

Primary Outcome Measures

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).
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).

Secondary Outcome Measures

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.

Full Information

First Posted
March 1, 2021
Last Updated
January 20, 2023
Sponsor
The University of Texas Health Science Center at San Antonio
search

1. Study Identification

Unique Protocol Identification Number
NCT04782726
Brief Title
Radiation Therapy Plan Quality Improvement Using Ideal Theoretical Isodose Distribution
Official Title
Radiation Therapy Plan Quality Improvement Using Ideal Theoretical Isodose Distribution
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
December 16, 2021 (Actual)
Primary Completion Date
January 20, 2023 (Actual)
Study Completion Date
January 20, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Texas Health Science Center at San Antonio

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Neoplasms

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Arm
Arm Type
Placebo Comparator
Arm 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.
Arm Title
Research Arm
Arm Type
Experimental
Arm 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.
Intervention Type
Other
Intervention Name(s)
Software Solution for Radiation Therapy Treatment
Other Intervention Name(s)
Treatment planning
Intervention Description
Software has been developed for individualized pre optimization evaluation of the patient anatomy and prescribed dose of radiation therapy.
Intervention Type
Other
Intervention Name(s)
Radiation therapy
Other Intervention Name(s)
Radiation treatment
Intervention Description
Standard of Care planning for Radiation therapy is used to treat the subjects for head and neck cancer
Primary Outcome Measure Information:
Title
Mean radiation dose to Organs at Risk (OAR)
Description
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).
Time Frame
Baseline to last treatment (up to 33 treatments or about 7 weeks)
Title
Maximum radiation dose to Organs at Risk (OAR)
Description
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).
Time Frame
Baseline to last treatment (up to 33 treatments or about 7 weeks)
Secondary Outcome Measure Information:
Title
Time required to plan radiation therapy dose
Description
The time required with and without individualized pre optimization information will be recorded and compared to determine efficiency.
Time Frame
CT Simulation to first treatment (about 1 week)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sotirios Stathakis, PhD
Organizational Affiliation
UT Health San Antonio
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mays Cancer Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Radiation Therapy Plan Quality Improvement Using Ideal Theoretical Isodose Distribution

We'll reach out to this number within 24 hrs