Clinical trial NCT06895564: Proton SBRT for Spinal Metastasis
Official title: A Pilot Study of Proton Stereotactic Body Radiotherapy for Spinal Metastasis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spinal Metastasis
Keywords: Proton SBRT
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sponsor class: OTHER
Collaborators: name: Sibley Foundation
First posted: 2025-03-26
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: Spine metastases are common with a prevalence of up to 30-50% among patients with a cancer diagnosis. As cancer survivorship improves, durable local control is essential to decrease the risk of pain and neurologic deficits that are associated with spinal metastasis. SBRT for these tumors has demonstrated overall local control rates of approximately 80-90% in the largest published series.

Emerging data highlight the importance of dose escalation for local control in SBRT for spinal metastases. The spinal cord is often the dose limiting structure in patients with spinal metastasis; however, achieving sufficiently high dose and acceptable target coverage while meeting dose constraints of other organs at risk (OARs) such as the small bowel or kidneys also poses a significant technical challenge when using current SBRT modalities for complex cases (e.g., extensive paraspinal disease, epidural disease, disease abutting the kidneys, re-irradiation setting). Maintaining safety is the first priority such that complex cases in current practice often require significant target volume under-coverage in order to meet organ at risk dose constraints, increasing the risk of progression and its associated neurologic morbidity and mortality.

To attempt to improve OAR sparing, proton SBRT has been utilized in other disease sites including prostate, non-small cell lung cancer, and liver. The unique qualities of proton beam therapy may improve target coverage while maintaining OAR sparing in cases where current practice with photon SBRT would require a limited dose and/or under-coverage of the target, both of which are associated with an increased risk of tumor progression.

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.

Primary outcomes:
measure: 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
Secondary outcomes:
measure: Rate of neurologic toxicity as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
timeFrame: Within 12 months post completion of SBRT treatment
measure: Interfraction and intrafraction setup and positioning as assessed by motion monitoring
timeFrame: Completion of SBRT treatment, approximately 3 weeks
measure: Actual spinal cord dose meets dose constraints as recommended by AAPM TG101
timeFrame: Completion of SBRT treatment, approximately 3 weeks
measure: Local control rate post-SBRT
timeFrame: 3, 6, 9, and 12 months post-SBRT treatment
measure: Incidence of vertebral compression fracture (VCF) post-SBRT
timeFrame: 3, 6, 9, and 12 months post-SBRT treatment
measure: Brief Pain Index (BPI) patient-reported outcome pre-SBRT and post-SBRT
timeFrame: Prior to SBRT treatment, and at 3, 6, 9, and 12 months post-SBRT treatment
measure: EORTC Quality of Life (QLQ) BM22 patient-reported outcome pre-SBRT and post-SBRT
timeFrame: Prior to SBRT treatment, and at 3, 6, 9, and 12 months post-SBRT treatment
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Kristin Redmond, MD
role: PRINCIPAL_INVESTIGATOR
References: