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

Head and Neck Cancer Clinical Trial

— PEAQ-RT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04379505
• Other study ID #: 202004210
• Status: Completed
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: December 5, 2023

Study information

• Verified date: December 2023
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 5, 2023
• Est. primary completion date: December 5, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	Varian Medical Systems

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Average time (days) required from initial consult to completion of radiation therapy for patient travel and visits to the department		Approximately 12 weeks
Secondary	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)

External Links

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