Clinical trial · Interventional
Evaluation of a Novel CT-On-Rails or Trilogy Stereotactic Spine Radiotherapy System (SSRS)
Phase I/II Evaluation of a Novel CT-On-Rails or Trilogy Stereotactic Spine Radiotherapy System (SSRS) for the Treatment of Metastatic Spine Disease
NCT00508443CI-TRIAL-00118436active not recruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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 spine radiotherapy is safe and effective in the treatment of metastatic spine tumors. The feasibility of this type of treatment will be studied as will any side effects related to the treatment. The precision and accuracy of the CT-on-rails will also be studied.
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 |
|---|---|---|---|
| Radiation Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Radiation Therapy
- description
- Radiation Therapy using CT-on-Rails or Trilogy procedure. Participants prescribed to receive 9 Gy x 3 so that a peripheral dose of 27 Gy is given to the tumor.
- interventionNames
- Radiation: Radiation Therapy
Primary outcomes (1)
- measure
- Patient Response (Pain Relief)
- timeFrame
- Baseline, 3, 6, 9, 12, 18, and 24 months, then every six months
- description
- The validated Brief Pain Inventory (BPI), MD Anderson Symptom Inventory (MDASI), and SF-12v2 Health Survey used to assess changes in these indicators compared to pre-treatment baseline. Response determined by follow-up questionaires. Time to maximal pain relief is the time from the first day of irradiation until the lowest pain score for average pain after radiotherapy. The "worst pain score" from BPI used as the marker for treatment success or failure.
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 wks of registration 2. Maximum of 2 metastatic sites in the spine to be irradiated over a single course of treatment. 3. Informed consent for irradiation or re-irradiation of spinal or para-spinal tumor (s) 4. Diagnosis cancer including but not limited to lung (non-small cell and small cell), breast, prostate, renal cell, melanoma, gastrointestinal, germ cell tumors, and unknown primary tumors 5. Karnofsky performance status of at least 40 (i.e. not requiring active hospitalization) 6. Maximum of 1 prior course of spine radiotherapy to the current region of interest allowed. 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. Patients already re-treated with radiation as part of this protocol will not be eligible for additional re-treatment 4. Unstable spine requiring surgical stabilization. 5. Sites outside the spine (eg. lung, liver) are not eligible for treatment 6. Systemic radiotherapy (Sr-89) within 30 days 7. Prior irradiation of the area to be treated within 3 months of registration 8. Patients currently receiving, or who have received chemotherapy within 30 days are not eligible 9. Inability to tolerate lying flat on treatment couch for greater than 30 minutes. 10. Patient with multiple myeloma 11. Patients unable to undergo MRI of the spine 12. Patients with pacemakers 13. Patients who have previously received maximum cord tolerance of 45 Gy in 5 weeks conventional fractionation or equivalent dose to the current area to be treated.
References
Publications (2)
- DERIVEDWang XS, Rhines LD, Shiu AS, Yang JN, Selek U, Gning I, Liu P, Allen PK, Azeem SS, Brown PD, Sharp HJ, Weksberg DC, Cleeland CS, Chang EL. Stereotactic body radiation therapy for management of spinal metastases in patients without spinal cord compression: a phase 1-2 trial. Lancet Oncol. 2012 Apr;13(4):395-402. doi: 10.1016/S1470-2045(11)70384-9. Epub 2012 Jan 27. PMID 22285199
- DERIVEDBoehling NS, Grosshans DR, Allen PK, McAleer MF, Burton AW, Azeem S, Rhines LD, Chang EL. Vertebral compression fracture risk after stereotactic body radiotherapy for spinal metastases. J Neurosurg Spine. 2012 Apr;16(4):379-86. doi: 10.3171/2011.11.SPINE116. Epub 2012 Jan 6. PMID 22225488