Combining Intraoperative Radiotherapy With Kyphoplasty for Treatment of Spinal Metastases (KYPHO-IORT)
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|ClinicalTrials.gov Identifier: NCT02480036|
Recruitment Status : Unknown
Verified September 2020 by Abhishek A. Solanki, Loyola University.
Recruitment status was: Recruiting
First Posted : June 24, 2015
Last Update Posted : September 7, 2020
|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|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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).
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, BSNfirstname.lastname@example.org|
|United States, Illinois|
|Loyola University Medical Center||Recruiting|
|Maywood, Illinois, United States, 60153|
|Contact: Beth Chiappetta, BSN 708-216-2568 email@example.com|
|Principal Investigator: William Small, MD|
|Principal Investigator:||William Small, MD||Loyola University|