Clinical trial · Interventional
Combining Intraoperative Radiotherapy With Kyphoplasty for Treatment of Spinal Metastases
NCT02480036CI-TRIAL-00046992KYPHO-IORTunknownPhase 1ClinicalTrials.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 primary objective is to evaluate the tolerability (side effects) of the intraoperative radio therapy (IORT) (e.g., wound healing, infections, bone necrosis, nerve, spinal cord damage, and pathological fracture), and the secondary objective is to evaluate the effectiveness of IORT (i.e., pain relief, quality of life, narcotic use, and tumor response).
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 Metastasis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intrabeam® | Device | — | UNRESOLVED |
| IORT with Kyphoplasty | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Combined IORT and Kyphoplasty
- description
- IORT with Kyphoplasty IORT Device: Intrabeam®
- interventionNames
- Radiation: IORT with Kyphoplasty
- Device: Intrabeam®
Primary outcomes (1)
- measure
- Pain
- timeFrame
- 52 weeks
- description
- Patient will rate the severity of pain on a numeric 0-10 scale with higher scores indicating more severe pain. Pain assessment will be done at baseline, day of the procedure, and during follow up visits for up to 52 weeks.
Secondary outcomes (1)
- measure
- Tumor Response
- timeFrame
- 52 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: * Metastatic patients from solid tumor * Estimated life expectancy of at least 3 months * Age \>= 50 years. * Karnofsky Performance Status \>= 70% * Numeric Pain Intensity Score \>= 3 * 10% or more loss of vertebrae height * Adequate organ and marrow function as defined below: * International normalized ratio (INR)/ prothrombin time (PT) within normal institutional limits * leukocytes \>= 3,000 microliter (mcL) * Absolute neutrophil count \>= 1,500 mcL * Platelets \>= 100,000 mcl * Total bilirubin within normal institutional limits * Abnormal aspartate transaminase (AST or SGOT) or alanine transaminase (ALT or SPGT) * Abnormal creatinine * Ability to understand and the willingness to sign a written informed consent Exclusion Criteria: * Patients who have had prior external beam radiotherapy or surgery in the area of planned intervention * Previous radiopharmaceuticals (i.e, Ra-222, Sr-90, etc) within 30 days of procedure * Patients who are receiving systemic therapy (chemotherapy, hormonal, immunotherapy, bisphosphonates, etc) or other investigational agents are eligible if the systemic therapy can be safely held two weeks prior to procedure. These therapies may be resumed two weeks after the procedure * Primary hematologic malignancies * Patients with clinical or radiographic evidence of spinal cord or cauda equine compression or effacement * Chronic vertebrae fracture of greater than 6 months or coexisting bilateral pedicle fracture * Previous kyphoplasty in the same area * Patients with severe spinal deformity requiring open reconstruction or extreme adiposity, in which determining placement of metal sleeve would be difficult by fluoroscopy (limited bone margin) * History of allergic reactions attributed to compounds of similar composition to agents used for kyphoplasty * Uncontrolled medical illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * Pre-menopausal female
References
Publications (19)
- BACKGROUNDBartels RH, van der Linden YM, van der Graaf WT. Spinal extradural metastasis: review of current treatment options. CA Cancer J Clin. 2008 Jul-Aug;58(4):245-59. doi: 10.3322/CA.2007.0016. Epub 2008 Mar 19. PMID 18354080
- BACKGROUNDBen-Josef E, Shamsa F, Williams AO, Porter AT. Radiotherapeutic management of osseous metastases: a survey of current patterns of care. Int J Radiat Oncol Biol Phys. 1998 Mar 1;40(4):915-21. doi: 10.1016/s0360-3016(97)00927-9. PMID 9531377
- BACKGROUNDColeman RE. Metastatic bone disease: clinical features, pathophysiology and treatment strategies. Cancer Treat Rev. 2001 Jun;27(3):165-76. doi: 10.1053/ctrv.2000.0210. PMID 11417967
- BACKGROUNDEck JC, Nachtigall D, Humphreys SC, Hodges SD. Comparison of vertebroplasty and balloon kyphoplasty for treatment of vertebral compression fractures: a meta-analysis of the literature. Spine J. 2008 May-Jun;8(3):488-97. doi: 10.1016/j.spinee.2007.04.004. Epub 2007 May 29. PMID 17588820
- BACKGROUNDFourney DR, Schomer DF, Nader R, Chlan-Fourney J, Suki D, Ahrar K, Rhines LD, Gokaslan ZL. Percutaneous vertebroplasty and kyphoplasty for painful vertebral body fractures in cancer patients. J Neurosurg. 2003 Jan;98(1 Suppl):21-30. doi: 10.3171/spi.2003.98.1.0021. PMID 12546384
- BACKGROUNDHage WD, Aboulafia AJ, Aboulafia DM. Incidence, location, and diagnostic evaluation of metastatic bone disease. Orthop Clin North Am. 2000 Oct;31(4):515-28, vii. doi: 10.1016/s0030-5898(05)70171-1. PMID 11043092
- BACKGROUNDHartsell WF, Scott CB, Bruner DW, Scarantino CW, Ivker RA, Roach M 3rd, Suh JH, Demas WF, Movsas B, Petersen IA, Konski AA, Cleeland CS, Janjan NA, DeSilvio M. Randomized trial of short- versus long-course radiotherapy for palliation of painful bone metastases. J Natl Cancer Inst. 2005 Jun 1;97(11):798-804. doi: 10.1093/jnci/dji139.