Quad Shot Radiation Therapy for Head and Neck Cancer
(PEAQ-RT Trial)

Recruiting in Palo Alto (17 mi)

Overseen byWade Thorstad, M.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Washington University School of Medicine

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Wade Thorstad, M.D.

Principal Investigator

Washington University School of Medicine

Eligibility Criteria

Inclusion Criteria

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).

Deemed medically fit for Quad shot radiation by treating physician

See 1 more

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.

Treatment Details

Interventions

Quad shot radiation (Radiation)

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Quad shot radiationExperimental Treatment2 Interventions

-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.