Clinical trial NCT04379505: Palliative Expeditiously Adaptive Quad Shot Radiation Therapy (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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Head and Neck Cancer
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Varian Medical Systems
First posted: 2020-05-07
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility as measured by the successful completion of Quad shot radiation using CBCT instead of routine CT simulation in 80% of attempted simulated patients
timeFrame: Completion of treatment by all patients enrolled (estimated to be 3 years and 12 weeks)
Secondary outcomes:
measure: Average time (days) required from initial consult to completion of radiation therapy for patient travel and visits to the department
timeFrame: Approximately 12 weeks
measure: Percentage of patients from whom repeat CT simulation was eliminated
timeFrame: Completion of treatment by all patients enrolled (estimated to be 3 years and 12 weeks)
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Wade Thorstad, M.D.
role: PRINCIPAL_INVESTIGATOR
References: