Clinical trial · Interventional
Single Versus Multiple Fractionated SSRS for Spinal Metastases
A Prospective Randomized Clinical Trial of Single Versus Multiple Fractionated Stereotactic Spine Radiosurgery for Patients With Spinal Metastases
NCT02608866CI-TRIAL-00039586unknownN/AClinicalTrials.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 investigators proposed this randomized study to determine the feasibility of delivering single-fraction 16-Gy versus 3-fraction 24-Gy toward spine metastatic lesion and to evaluate their toxicity profiles. The investigators' analysis will provide robust data as well as predictive factors regarding the outcome after SSRS.
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 |
|---|---|---|---|
| Secondary Malignant Neoplasm of Spine | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MF-SSRS | Radiation | — | UNRESOLVED |
| SF-SSRS | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- SF-SSRS
- description
- Single-Fraction (SF) Stereotactic Spine Radiosurgery
- interventionNames
- Radiation: SF-SSRS
- type
- EXPERIMENTAL
- label
- MF-SSRS
- description
- Multiple-Fraction (MF) Stereotactic Spine Radiosurgery
- interventionNames
- Radiation: MF-SSRS
Primary outcomes (1)
- measure
- Common Toxicity Criteria for Adverse Events version 4 Grade 3 or higher adverse events related to spine radiosurgery
- timeFrame
- 16 weeks after SSRS
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion criteria To be eligible for inclusion, patients must fulfill the following criteria: 1. Patients with a histologic diagnosis of non-hematopoietic malignancy 2. Radiographic evidence of localized spine metastases without leptomeningeal involvement or intramedullary lesion 3. Maximum three separate sites with a maximal involvement of two continuous vertebral levels 4. Patients do not have prior radiotherapy to the index spine(s) 5. Patients with metastatic epidural spinal cord compression (≥ grade 2) at the index spine(s) who will not be treated with spine surgery after evaluation by neurosurgeon or orthopedic doctor 6. Age ≥ 20 years 7. Karnofsky performance status (KPS) ≥ 60%. 8. Life expectancy of ≥ 4 month. 9. Women of childbearing potential and male participants must practice adequate contraception 10. Patients must be able to comply with the study protocol and follow-up schedules and provide study-specific informed consent Exclusion criteria Patients fulfill any of the following criteria will be excluded from this trial 1. Prior radiotherapy to the index spine(s) 2. Serum creatinine \> 2.0 mg/dL within 90 days prior registration 3. Contraindication to MRI such as implanted metal devices or foreign bodies, severe claustrophobia 4. Patients with leptomeningeal involvement or intramedullary metastasis 5. Inability to tolerate treatment procedure 6. Bony retropulsion causing neurologic abnormality 7. Severe, active comorbidities which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and adverse events of the protocol, or limit compliance with study requirements, defined as follows: * Uncontrolled active infection requiring intravenous antibiotics at the time of registration * Transmural myocardial infarction ≤ 6 months prior to registration * Unstable angina or congestive heart failure requiring hospitalization ≤ 6 months prior to registration * Life-threatening uncontrolled clinically significant cardiac arrhythmias * Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects * Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration * Uncontrolled psychiatric disorder 8. Will receive any other investigational agent or chemotherapy and/or target therapies during treatment 9. Women of childbearing potential and male participants who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the radiation treatment involved in this study may be significantly teratogenic
References
Publications (0)
Data not yet available
No reference posted for this study.