NCT05831579

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

A Phase I Trial of Palliative Spatially Fractionated (GRID) Radiotherapy Using Intensity Modulated Proton Therapy

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Unresectable Solid Tumor
• Metastatic Cancer

Interventions

Type	Name	Description
RADIATION	Proton GRID Radiotherapy	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.

Timeline

• Start date: 2023-05-12
• Primary completion: 2027-06-30
• Completion: 2027-06-30
• First posted: 2023-04-26
• Last updated: 2026-03-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study