Phase 2
N=71
Evaluation of Single Session Stereotactic Body Radiotherapy
Spinal Neoplasms
Bottom Line
View on ClinicalTrials.gov: NCT00492817 ↗Enrolled (actual)
71
Serious AEs
9.9%
Results posted
Oct 2025
Primary outcome: Primary: Complete Pain Relief Using Stereotactic Body Radiotherapy (SBRT) to Treat Spine and Para- Spinal Tumors in a Single Session — 18 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Stereotactic Body Radiotherapy (Procedure)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- M.D. Anderson Cancer Center
- Primary completion
- Nov 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Complete Pain Relief Using Stereotactic Body Radiotherapy (SBRT) to Treat Spine and Para- Spinal Tumors in a Single Session |
18 | — |
| PRIMARY Local Tumor Control Rate |
48 | — |
| PRIMARY Paralysis (Grade 4 Motor Neuropathy) |
— | — |
Summary
The goal of this clinical research study is to find out if stereotactic body radiotherapy to the spine using computerized tomography (CT)-on-Rails is safe and effective in the treatment of metastatic spine tumors.
Objectives:
* Establish the safety and efficacy of using stereotactic body radiotherapy (SBRT) to treat spine and para-spinal tumors in a single session.
* Document frequency and severity of pain, symptoms and symptom interference, as well as quality of life before and after treatment.
* Document changes in neurological function at defined intervals compared to pre-treatment neurological function.
Eligibility Criteria
Inclusion Criteria
- Radiographically documented spine or paraspinal metastasis demonstrated on spine MRI within 4 weeks of registration
- Maximum of 2 metastatic sites in the spine to be irradiated in single session
- Informed consent for irradiation of spinal or para-spinal tumor (s)
- Diagnosis of cancer including but not limited to lung (non-small cell and small cell), breast, prostate, renal cell, melanoma, gastrointestinal, and germ cell tumors, unknown primary tumors
- Karnofsky performance status of at least 40 (ie not requiring active hospitalization)
Exclusion Criteria
- Worsening neurological status due to radiographic evidence of spinal cord compression requiring immediate surgical decompression or emergent conventional external radiation therapy.
- Delay in initiation of radiation treatment would be potentially detrimental to neurological outcome
- Prior irradiation to current site of interest in the spine
- Spinal metastasis in the cervical spine are not eligible for treatment
- Unstable spine requiring surgical stabilization.
- Sites outside the spine (eg. lung, liver) are not eligible for treatment
- Patients currently receiving, or who have received chemotherapy within 30 days are not eligible
- Inability to tolerate lying flat on treatment couch for greater than 30 minutes.
- Patient with multiple myeloma
- Patients unable to undergo MRI of the spine
- Patients with pacemakers
Data sourced from ClinicalTrials.gov (NCT00492817). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.