Palliative Spatially Fractionated (GRID) Radiotherapy Using Intensity Modulated Proton Therapy

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT05831579
Status
Recruiting
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Conditions

  • Metastatic Cancer
  • Unresectable Solid Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Proton GRID Radiotherapy — RADIATION
    The proton GRID radiotherapy prescription dose is 20 Gy x 3 fractions to the tumor, with an integrated dose of 6 Gy x 3 fractions to the PTV. Treatment to multiple lesions within the PTV is allowed (ex. a dominant lesion plus satellites). Multiple proton GRID radiotherapy plans may be delivered on the same day or different days, but they cannot overlap.

Study Details

Spatially fractionated radiotherapy (SFRT or GRID) addresses some limitations of traditional stereotactic body radiation therapy by relying on beam collimation to create high-dose "peaks" and intervening low-dose "valleys" throughout the target volume. Standard palliative radiotherapy regimens provide limited durability of response, and there are challenges with delivery to large tumors or in previously irradiated fields. In this study, Proton GRID radiotherapy will be used to deliver three-fraction palliative radiotherapy to patients with tumors needing palliative radiation. The safety and efficacy of this approach will be assessed. It is hypothesized that GRID is highly effective, immunogenic, and associated with low rates of toxicity.

Key Dates

Start date
May 12, 2023
Status verified
Mar 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
24 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A: Reirradiation of Treatment Fields
    Radiotherapy will consist of 20 Gy proton GRID radiotherapy x 3 fractions.
  • Experimental: Cohort B: De Novo Radiation Treatment Fields
    Radiotherapy will consist of 20 Gy proton GRID radiotherapy x 3 fractions.

Primary Outcome Measure

Rate of treatment-related acute toxicity [ Time Frame: From start of treatment through 90 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University School of MedicineSt LouisMissouri63110
Anthony Apicelli, M.D.
[email protected]
314-362-8610
Anthony Apicelli, M.D. (PRINCIPAL_INVESTIGATOR)
Clifford Robinson, M.D. (SUB_INVESTIGATOR)
Stephanie Perkins, M.D. (SUB_INVESTIGATOR)
Justin Barnes, M.D. (SUB_INVESTIGATOR)
Nels Knutson, Ph.D. (SUB_INVESTIGATOR)
Yi Huang, M.S. (SUB_INVESTIGATOR)
Michael Prusator, Ph.D. (SUB_INVESTIGATOR)
Tianyu Zhao, Ph.D. (SUB_INVESTIGATOR)
Xiandong Zhao, Ph.D. (SUB_INVESTIGATOR)

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By research site
Washington University School of Medicine· St Louis, MO

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