Combining Intraoperative Radiotherapy With Kyphoplasty for Treatment of Spinal Metastases

Status unconfirmed · Phase 1

Conditions studied: Spinal Metastasis

In brief

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).

Key facts

Study ID

NCT02480036

Run by

Loyola University

People needed

10

Starts

2014-12-01

Expected to finish

2020-12-01

Last updated by the study team

2020-09-07

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Loyola University Medical Center — Maywood, Illinois, United States (enrolling)

Full record on ClinicalTrials.gov

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