Radiation Therapy Plan Quality Improvement Using Ideal Theoretical Isodose Distribution

NCT ID: NCT04782726

Last Updated: 2023-01-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-16
• Study Completion Date: 2023-01-20

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.

Conditions

Head and Neck Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: PLACEBO_COMPARATOR

Radiation therapy

Intervention Type: OTHER

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

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.

Group Type: EXPERIMENTAL

Software Solution for Radiation Therapy Treatment

Intervention Type: OTHER

Software has been developed for individualized pre optimization evaluation of the patient anatomy and prescribed dose of radiation therapy.

Radiation therapy

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: OTHER

Radiation therapy

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

Intervention Type: OTHER

Other Intervention Names

Treatment planning; Radiation treatment

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Texas Health Science Center at San Antonio

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sotirios Stathakis, PhD

Role: PRINCIPAL_INVESTIGATOR

UT Health San Antonio

Locations

Mays Cancer Center

San Antonio, Texas, United States

Countries

United States

Other Identifiers

HSC20200678H

Identifier Type: OTHER

Identifier Source: secondary_id

CTMS# 20-0114

Identifier Type: -

Identifier Source: org_study_id