Clinical trial · Interventional
Evaluation of Single Session Stereotactic Body Radiotherapy
Phase I/II Evaluation of Single Session Stereotactic Body Radiotherapy for Spinal or Paraspinal Metastases
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Spinal Neoplasms | Spinal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Stereotactic Body Radiotherapy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single Session Stereotactic Body Radiotherapy (SBRT)
- description
- On day 1 of radiation treatment, a CT scan using CT-on-Rails in the same treatment room, immediately before the radiation treatment will be performed.
- interventionNames
- Procedure: Stereotactic Body Radiotherapy
Primary outcomes (3)
- measure
- Complete Pain Relief Using Stereotactic Body Radiotherapy (SBRT) to Treat Spine and Para- Spinal Tumors in a Single Session
- timeFrame
- Six months after completion of radiation therapy
- description
- To measure 6-month complete pain relief, i.e., 6-month "pain worst" from the BPI being zero
- measure
- Local Tumor Control Rate
- timeFrame
- local tumor control rate, the time frame is up to 48 months
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: 1. Radiographically documented spine or paraspinal metastasis demonstrated on spine MRI within 4 weeks of registration 2. Maximum of 2 metastatic sites in the spine to be irradiated in single session 3. Informed consent for irradiation of spinal or para-spinal tumor (s) 4. 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 5. Karnofsky performance status of at least 40 (ie not requiring active hospitalization) Exclusion Criteria: 1. Worsening neurological status due to radiographic evidence of spinal cord compression requiring immediate surgical decompression or emergent conventional external radiation therapy. 2. Delay in initiation of radiation treatment would be potentially detrimental to neurological outcome 3. Prior irradiation to current site of interest in the spine 4. Spinal metastasis in the cervical spine are not eligible for treatment 5. Unstable spine requiring surgical stabilization. 6. Sites outside the spine (eg. lung, liver) are not eligible for treatment 7. Patients currently receiving, or who have received chemotherapy within 30 days are not eligible 8. Inability to tolerate lying flat on treatment couch for greater than 30 minutes. 9. Patient with multiple myeloma 10. Patients unable to undergo MRI of the spine 11. Patients with pacemakers
References
Publications (0)
Data not yet available