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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 : October 3, 2017
Sponsor:
Information provided by (Responsible Party):
Abhishek Solanki, Loyola University

Study Description
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Brief 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).

Condition or disease Intervention/treatment Phase
Spinal Metastasis Radiation: IORT with Kyphoplasty Device: Intrabeam® Phase 1

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Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
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 2018
Estimated Study Completion Date : December 2019
Arms and Interventions
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Arm Intervention/treatment
Experimental: Combined IORT and Kyphoplasty
IORT with Kyphoplasty IORT Device: Intrabeam®
 Radiation: IORT with Kyphoplasty
IORT with kyphoplasty is give concurrently for the treatment of spinal metastases

Device: Intrabeam®


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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).


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

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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
Contact: Beth Chiappetta, BSN 708-216-2568 bchiappetta@lumc.edu

Locations
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         
Sponsors and Collaborators
Loyola University
Investigators
Principal Investigator: William Small, MD Loyola University
More Information
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Publications:

Responsible Party: Abhishek Solanki, Assistant Professor, Loyola University
ClinicalTrials.gov Identifier: NCT02480036     History of Changes
Other Study ID Numbers: 206824
206824091714 ( Other Identifier: Loyola University Chicago )
First Posted: June 24, 2015    Key Record Dates
Last Update Posted: October 3, 2017
Last Verified: September 2017

Keywords provided by Abhishek Solanki, Loyola University:
IORT
Kyphoplasty
Spine
Cancer

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes