Proton SBRT for Spinal Metastasis

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study ID
NCT06895564
Status
Recruiting

Conditions

  • Spinal Metastasis

Eligibility Criteria

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

Interventions

  • Spinal Proton SBRT — RADIATION
    Patients will be treated with spinal proton SBRT over 5 fractions, with a prescription dose of 6 Gray equivalent (GyE) per fraction to the planning target volume.

Study Details

This is a single-arm pilot study of proton stereotactic body radiotherapy (SBRT) for nonhematologic spinal metastasis in patients with complex lesions that are unable to be effectively treated with standard of care photon SBRT defined as inability to develop a photon SBRT plan that achieves adequate coverage (≥80% planning treatment volume (PTV) coverage)) with a prescription dose of 30 Gy in 5 fractions.

Key Dates

Start date
Apr 22, 2025
Status verified
Apr 2026
Primary completion
Apr 30, 2030
Completion
May 31, 2030

Study Design

Enrollment
12 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Spinal Proton SBRT
    Proton SBRT for nonhematologic spinal metastasis in patients with complex lesions that are unable to be effectively treated with standard of care photon SBRT.

Primary Outcome Measure

Rate of successful delivery of at least one fraction for 8 of 12 patients with spine metastases [ Time Frame: Completion of SBRT treatment, approximately 3 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins HospitalBaltimoreMaryland21287
Dana B Kaplin, MPH
410-614-3950

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