Palliative Expeditiously Adaptive Quad Shot Radiation Therapy (PEAQ-RT) (PEAQ-RT)

Palliative Expeditiously Adaptive Quad Shot Radiation Therapy (PEAQ-RT): A Pilot Study of Consolidated Simulation and Target Identification of Quad Shot Radiation Therapy Using an Adaptive Radiotherapy Workflow With a Novel Ring Gantry Radiotherapy Device

The investigators propose evaluating the feasibility of using the novel cone beam computed tomography (CBCT)-guided Ethos system to deliver expedited, adaptive Quad shot radiation for the purpose of palliative radiation of patients with advanced head and neck cancers or patients with a history of any malignancy experiencing current head and neck lesions. Quad shot radiation was selected as the palliative regimen of choice given its low toxicity profile, well published efficacy in palliation, frequent usage in the US for palliation of head and neck cancers, and safety in the setting of re-irradiation. The use of the Ethos platform to perform online adaptive radiation planning and delivery remains novel and untested. The Ethos system would be used to consolidate CT simulation, replanning, and treatment for Quad shot patients receiving treatment with the benefit of reduced patient travel and a reduction in the unwanted delay between Quad shot cycles. The goal of this pilot study will be to evaluate the feasibility of the Ethos system to eliminate the need for a CT simulation for cycles 2 and 3 of Quad shot radiation.

Study Overview

• Status: Completed
• Conditions: Head and Neck Cancer
• Intervention / Treatment: Device: Ring gantry kV-CBCT combined with linear accelerator (Halcyon); Radiation: Quad shot radiation

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• History of a head and neck malignancy or history of any malignancy experiencing current head and neck lesions suitable for radiation. Past history of radiotherapy is allowed for inclusion and brain metastases are allowed for inclusion.
• Deemed medically fit for Quad shot radiation by treating physician
• At least 18 years of age.
• Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).

Exclusion Criteria:

-Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 14 days of study entry. If pregnancy test is not clinically indicated as determined by treating physician or protocol PI, documentation of this exception is sufficient in lieu of pregnancy test.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Quad shot radiation; -Radiotherapy will consist of Quad shot radiation delivered on the Ethos ring gantry kV-CBCT combined with linear accelerator system to a dose of 14 Gy in four, twice-daily fractions of 3.5 Gy delivered at least 6 hours apart over two days for a possible total of 3 cycles delivered in 3 to 4 intervals for a cumulative dose of of 42 Gy in 12 fractions. Cycle 2 and 3 of treatment is not mandated per protocol but may be given at the discretion of the treating physician.

Device: Ring gantry kV-CBCT combined with linear accelerator (Halcyon); -Varian Medical Systems is the manufacturer; Radiation: Quad shot radiation; Treatment of each cycle should ideally take place on two consecutive days. Allowing for holidays, weekends, and other scheduling issues or unexpected delays, treatment may be completed within five calendar days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Feasibility as measured by the successful completion of Quad shot radiation using CBCT instead of routine CT simulation in 80% of attempted simulated patients	Completion of treatment by all patients enrolled (estimated to be 3 years and 12 weeks)

Secondary Outcome Measures

Outcome Measure	Time Frame
Average time (days) required from initial consult to completion of radiation therapy for patient travel and visits to the department	Approximately 12 weeks
Percentage of patients from whom repeat CT simulation was eliminated	Completion of treatment by all patients enrolled (estimated to be 3 years and 12 weeks)

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: Varian Medical Systems
• Investigators: Principal Investigator: Wade Thorstad, M.D., Washington University School of Medicine

Publications and helpful links

Helpful Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Actual): December 5, 2023
• Study Completion (Actual): December 5, 2023

Study Registration Dates

• First Submitted: May 4, 2020
• First Submitted That Met QC Criteria: May 4, 2020
• First Posted (Actual): May 7, 2020

Study Record Updates

• Last Update Posted (Estimated): December 8, 2023
• Last Update Submitted That Met QC Criteria: December 7, 2023
• Last Verified: December 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: 202004210

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The investigators will provide a summary of basic outcomes and clinical results within one year.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No