Combining Intraoperative Radiotherapy With Kyphoplasty for Treatment of Spinal Metastases (NCT02480036) | Clinical Trial Compass
UnknownPhase 1
Combining Intraoperative Radiotherapy With Kyphoplasty for Treatment of Spinal Metastases
United States10 participantsStarted 2014-12
Plain-language summary
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).
Who can participate
Age range50 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 kyphopl…