Proton therapy for spinal tumors

A Pilot Study of Proton Stereotactic Body Radiotherapy for Spinal Metastasis

This study is testing if proton therapy can help people with tough-to-treat spinal tumors feel better by targeting the tumors more precisely while protecting nearby healthy tissue.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 12 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Baltimore, Maryland)
• Trial ID: NCT06895564 on ClinicalTrials.gov

What this trial studies

This pilot study evaluates the use of proton stereotactic body radiotherapy (SBRT) for patients with nonhematologic spinal metastasis who have complex lesions that cannot be effectively treated with standard photon SBRT. The study aims to improve local control rates by utilizing proton therapy, which may allow for better target coverage while minimizing damage to surrounding organs at risk. Participants will receive a prescribed dose of 30 Gy in 5 fractions, and the study will assess the safety and efficacy of this approach in challenging cases.

Who should consider this trial

Good fit: Ideal candidates include adults with confirmed nonhematologic malignancies and complex spinal metastases that cannot be treated effectively with photon SBRT.

Not a fit: Patients with hematologic malignancies or those whose spinal metastases can be adequately treated with standard photon SBRT may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide improved local control of spinal metastases, reducing pain and neurological deficits for patients.

How similar studies have performed: While proton therapy has shown promise in other cancer types, this specific application for spinal metastases is novel and has not been extensively tested.

Eligibility criteria

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.

Where this trial is running

Baltimore, Maryland

• Johns Hopkins Hospital — Baltimore, Maryland, United States (Recruiting)

Study contacts

• Principal investigator: Kristin Redmond, MD — Johns Hopkins University
• Study coordinator: Kristin Redmond, MD

Conditions Spinal Metastasis; Proton SBRT