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New treatment option for Spinal Metastasis
Official title Proton SBRT for Spinal Metastasis
ClinicalTrials.gov ID: NCT06895564
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- Extensive paraspinal disease
- Reirradiation setting
You likely can't join 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...
- 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...
See the full eligibility criteria
- 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...
- 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.
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Baltimore, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Baltimore, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.