Radiation Therapy Plan Quality Improvement Using Ideal Theoretical Isodose Distribution

NCT04782726 | Completed DMC

• 2 other identifiers: CTMS# 20-0114HSC20200678H
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Neoplasms

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Time required to plan radiation therapy dose

  CT Simulation to first treatment (about 1 week)

Study Arms (2)

Control Arm

PLACEBO COMPARATOR

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

Research Arm

EXPERIMENTAL

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

Interventions

Software Solution for Radiation Therapy Treatment OTHER

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

Also known as: Treatment planning

Research Arm

Radiation therapy OTHER

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

Also known as: Radiation treatment

Control Arm; Research Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead

Study Sites (1)

Mays Cancer Center

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Sotirios Stathakis, PhD

  UT Health San Antonio

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2021
• First Posted: March 4, 2021
• Study Start: December 16, 2021
• Primary Completion: January 20, 2023
• Study Completion: January 20, 2023
• Last Updated: January 25, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)