Recruiting

Proton SBRT

Sponsor:

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Code:

NCT06895564

Conditions

Spinal Metastasis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Spinal Proton SBRT

Study Details

Brief 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.

Conditions

Spinal Metastasis

Study ID

NCT06895564

Start date

Apr 22, 2025

Status verified date

Apr, 2026

Completion date

May, 2030

Anticipated

Primary completion date

Apr, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Histologic proof or unequivocal cytologic proof of nonhematologic malignancy. This may be obtained from either the primary or any metastatic site.
2. Participants must have radiographic evidence of spinal metastasis on MRI.
3. 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:

1. Extensive paraspinal disease
2. Reirradiation setting
3. Epidural extension (Bilsky grade ≥1c)
4. Age ≥ 18 years.
5. Eastern Cooperative Oncology Group (ECOG) performance status ≤2 (Karnofsky >60%).
6. Patients of childbearing potential (male or female) must practice adequate contraception due to possible harmful effects of radiation therapy on an unborn child.
7. Patients must have the ability to understand and the willingness to sign a written informed consent document.
8. All patients must be informed of the investigational nature of this study and must be given written informed consent in accordance with institutional and federal guidelines.

Exclusion Criteria:

1. 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.
2. Patients who are unable to receive MRIs will be excluded from the study since MRIs will be critical in treatment planning.
3. 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.

Study Design

Enrollment

12 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Spinal Proton SBRT

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.

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 and Locations

Central contacts

Locations

Johns Hopkins Hospital

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

More Information

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Last update posted

Apr 29, 2026

Last verified

Apr, 2026

Keywords

  • Proton SBRT

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins on 2026-04-29.