Clinical trial · Interventional
Randomized Study of Stereotactic Body Radiotherapy vs. Conventional Radiation for Spine Metastasis
Randomized Ph II Study of Stereotactic Body Radiotherapy (SBRT) Versus Conventional Radiation for Spine Metastasis
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Local IRB decision due to poor accrual
Summary
Brief summary (as posted)
The purpose of this study is to determine how effective SBRT is compared to traditional radiation in treating the cancer that has spread to your spine and is causing pain. SBRT is delivered at a higher dose for a shorter period of time when compared to standard radiation therapy and the aim is to see if there will be an improvement both in pain control and your cancer It is not known whether SBRT is better or worse than current standard therapy. If you are selected to receive the experimental treatment in this research study, SBRT uses highly focused x-rays that deliver a single high dose to a specific area of the spine compared to conventional standard radiation over a period of 10 days which has been the standard proven treatment to help your condition. The investigators will also determine which treatment provides the most rapid pain relief with the least side effects. It is possible that SBRT may not be better or could be more toxic. The investigators will conduct quality of life assessments and pain scale index to assess how you are feeling once you have had the intervention.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Primary Tumor | Primary Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| External Beam Radiation Therapy | Radiation | — | UNRESOLVED |
| Radiosurgery/SBRT | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Radiosurgery/SBRT
- description
- Radiosurgery/SBRT
- interventionNames
- Radiation: Radiosurgery/SBRT
- type
- ACTIVE_COMPARATOR
- label
- External Beam Radiation Therapy
- description
- External Beam Radiation Therapy
- interventionNames
- Radiation: External Beam Radiation Therapy
Primary outcomes (1)
- measure
- Pain Control as Measured by NPRS
- timeFrame
- 2 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed primary tumor or metastatic cancer with radiological diagnosis of spine metastasis * The patient must have localized spine metastasis from the C1 to L5 levels by a screening imaging study * Zubrod Performance Status 0-2 * History/physical examination within 2 weeks prior to registration * Negative pregnancy test within 2 weeks prior to registration for women of childbearing potential * Women of childbearing potential and male participants who are sexually active must agree to use a medically effective contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. * MRI of the involved spine within 4 weeks prior to registration to determine the extent of the spine involvement * Numerical Rating Pain Scale within 1 week prior to registration; the patient must have a score on the Scale of \>5 for at least one of the planned sites for spine radiosurgery. Patients taking medication for pain at the time of registration are eligible. * Neurological examination within 1 week prior to registration to rule out rapid neurologic decline Exclusion Criteria: * Histology of myeloma, lymphoma or germ cell tumors. * Non-ambulatory patients * Spine instability due to a compression fracture * \> 50% loss of vertebral body height * Frank spinal cord displacement or epidural involvement with\> 25% encirclement of cord or \>25% spinal canal involvement. * Prior radiation to the index spine * Patients for whom an MRI of the spine is medically contraindicated * Uncontrolled intercurrent illness
References
Publications (0)
Data not yet available