Proton SBRT for Spinal Metastasis

NCT06895564 | Recruiting

• 2 other identifiers: J2463IRB00441921
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Keywords

Proton SBRT

Outcome Measures

Primary Outcomes (1)

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

  To assess the feasibility of proton SBRT in patients with nonhematologic spine metastases that are unable to be effectively treated with photon SBRT. Feasibility will be determined by a successful delivery of at least one fraction for 8 of 12 patients with spine metastases.

  Completion of SBRT treatment, approximately 3 weeks

Secondary Outcomes (7)

• Rate of neurologic toxicity as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0

  Within 12 months post completion of SBRT treatment

• Interfraction and intrafraction setup and positioning as assessed by motion monitoring

  Completion of SBRT treatment, approximately 3 weeks

• Actual spinal cord dose meets dose constraints as recommended by AAPM TG101

  Completion of SBRT treatment, approximately 3 weeks

• Local control rate post-SBRT

  3, 6, 9, and 12 months post-SBRT treatment

• Incidence of vertebral compression fracture (VCF) post-SBRT

  3, 6, 9, and 12 months post-SBRT treatment

Study Arms (1)

Spinal Proton SBRT

OTHER

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

Radiation: Spinal Proton SBRT

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.

Spinal Proton SBRT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%).
• Patients of childbearing potential (male or female) must practice adequate contraception due to possible harmful effects of radiation therapy on an unborn child.
• Patients must have the ability to understand and the willingness to sign a written informed consent document.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• Sibley Foundation: collaborator

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

RECRUITING

Study Officials

• Kristin Redmond, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kristin Redmond, MD

CONTACT

410-955-6980; kjanson3@jhmi.edu

Ryan Manuel

CONTACT

410-955-4261; rmanuel5@jhmi.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2025
• First Posted: March 26, 2025
• Study Start: April 22, 2025
• Primary Completion (Estimated): April 1, 2030
• Study Completion (Estimated): May 1, 2030
• Last Updated: April 29, 2026

Record last verified: 2026-04

Locations

US (1)