Proton SBRT for Spinal Metastasis
ConditionSpinal Metastasis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Extensive paraspinal disease
Reirradiation setting
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Spinal Proton SBRT
RadiationPatients 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.
Treatment groups
12 Participants
are divided into 1 treatment groupGroup A: Spinal Proton SBRTOther 1 intervention
Trial outcomes
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.
Time frame
Completion of SBRT treatment, approximately 3 weeksSecondary outcomes
1
Rate of neurologic toxicity as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
To estimate the rate of neurologic toxicity, defined as CTCAE v5.0 ≥ grade 3, within 12 months after completion of SBRT.
Time frame
Within 12 months post completion of SBRT treatment2
Interfraction and intrafraction setup and positioning as assessed by motion monitoring
To verify inter- and intrafraction patient setup and motion uncertainty as assessed by motion monitoring within 2 millimeters (mm) of patient setup used for radiation planning
Time frame
Completion of SBRT treatment, approximately 3 weeks3
Actual spinal cord dose meets dose constraints as recommended by AAPM TG101
To determine whether the actual relative biologic effectiveness (RBE) weighted dose delivered to the spinal cord during proton spinal SBRT meets dose constraints as recommended by American Association of Physicists in Medicine Task Group 101 (AAPM TG101).
Time frame
Completion of SBRT treatment, approximately 3 weeks4
Local control rate post-SBRT
To estimate the local control rate at 3, 6, 9, and 12 months following proton spinal SBRT. Assessed using standard of care imaging obtained every 3 months- comparing imaging studies before SBRT with progressive disease on CT and/or MRI in the treatment volume or at the margin of the treatment field.
Time frame
3, 6, 9, and 12 months post-SBRT treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Lead sponsor
Sibley Foundation
Collaborator
Source ClinicalTrials.gov