Combining Intraoperative Radiotherapy With Kyphoplasty for Treatment of Spinal Metastases (KYPHO-IORT)
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ClinicalTrials.gov Identifier: NCT02480036 |
Recruitment Status :
Recruiting
First Posted : June 24, 2015
Last Update Posted : September 7, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Spinal Metastasis | Radiation: IORT with Kyphoplasty Device: Intrabeam® | Phase 1 |

Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 10 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Combining Intraoperative Radiotherapy With Kyphoplasty for Treatment of Spinal Metastases |
Study Start Date : | December 2014 |
Estimated Primary Completion Date : | December 2020 |
Estimated Study Completion Date : | December 2020 |
Arm | Intervention/treatment |
---|---|
Experimental: Combined IORT and Kyphoplasty
IORT with Kyphoplasty IORT Device: Intrabeam®
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Radiation: IORT with Kyphoplasty
IORT with kyphoplasty is give concurrently for the treatment of spinal metastases Device: Intrabeam® |
- Pain [ Time Frame: 52 weeks ]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.
- Tumor Response [ Time Frame: 52 weeks ]Patients will be classified at week 52 as having (1) disappearance of the treated lesion (i.e., complete response), (2) at least 30% decrease in the diameter of the treated lesion (i.e., partial response), (3) at least 20% increase in the diameter of the treated lesion (i.e., progressive disease), or (4) Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease (i.e., stable disease).

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Ages Eligible for Study: | 50 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02480036
Contact: Beth Chiappetta, BSN | 708-216-2568 | bchiappetta@lumc.edu |
United States, Illinois | |
Loyola University Medical Center | Recruiting |
Maywood, Illinois, United States, 60153 | |
Contact: Beth Chiappetta, BSN 708-216-2568 bchiappetta@lumc.edu | |
Principal Investigator: William Small, MD |
Principal Investigator: | William Small, MD | Loyola University |
Responsible Party: | Abhishek A. Solanki, Assistant Professor, Loyola University |
ClinicalTrials.gov Identifier: | NCT02480036 |
Other Study ID Numbers: |
206824 206824091714 ( Other Identifier: Loyola University Chicago ) |
First Posted: | June 24, 2015 Key Record Dates |
Last Update Posted: | September 7, 2020 |
Last Verified: | September 2020 |
IORT Kyphoplasty Spine Cancer |
Neoplasm Metastasis Neoplastic Processes Neoplasms Pathologic Processes |