RecruitingNot Applicable

Proton SBRT for Spinal Metastasis

United States12 participantsStarted 2025-04-22

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Histologic proof or unequivocal cytologic proof of nonhematologic malignancy. This may be obtained from either the primary or any metastatic site.
✓. Participants must have radiographic evidence of spinal metastasis on MRI.
✓. Participants must have a complex case that is unable to be effectively treated with photon SBRT, defined as inability to develop a photon SBRT plan that achieves adequate coverage (≥80% PTV coverage) with a prescription dose of 30 Gy in 5 fractions. Such cases include:
✓. Extensive paraspinal disease
✓. Reirradiation setting
✓. Epidural extension (Bilsky grade ≥1c)
✓. Age ≥ 18 years.
✓. Eastern Cooperative Oncology Group (ECOG) performance status ≤2 (Karnofsky \>60%).

Exclusion criteria

✕. Participants may not have a spinal metastases case amenable to standard of care photon SBRT planning techniques that achieve ≥80% PTV coverage with a prescription dose of 30 Gy in 5 fractions.
✕. Patients who are unable to receive MRIs will be excluded from the study since MRIs will be critical in treatment planning.
✕. Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

What they're measuring

Rate of successful delivery of at least one fraction for 8 of 12 patients with spine metastases

Timeframe: Completion of SBRT treatment, approximately 3 weeks

Trial details

NCT IDNCT06895564

SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2030-04

Contact for this trial

Kristin Redmond, MD

410-955-6980 kjanson3@jhmi.edu

View on ClinicalTrials.gov More Spinal Metastasis trials