Vertebral Augmentation and Radiotherapy of Collapse Spinal Metastatic Cancer
|ClinicalTrials.gov Identifier: NCT02376933|
Recruitment Status : Terminated (PI left the department; protocol transfer did not take place.)
First Posted : March 3, 2015
Results First Posted : November 7, 2018
Last Update Posted : November 7, 2018
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Cancers Multiple Myeloma Vertebral Fracture||Procedure: Vertebroplasty Radiation: Radiotherapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 2 Study of Vertebral Augmentation and Radiotherapy in Painful or at Risk of Collapse Spinal Metastatic Cancer/Multiple Myeloma|
|Actual Study Start Date :||August 20, 2013|
|Actual Primary Completion Date :||August 10, 2016|
|Actual Study Completion Date :||April 7, 2017|
Experimental: Vertebroplasty with Radiotherapy
Vertebroplasty with Radiotherapy is given in either order. Radiotherapy dosage is at the discretion of the treating physician. Vertebroplasty is applied to fractured vertebrae.
Under imaging guidance, a fractured vertebral body is stabilized with injected bone cement.
Other Name: kyphoplasty
Radiotherapy of metastatic lesions to the spine.
- Pain Assessment From the Worst Pain Score on Brief Pain Inventory as Compared to Historical Radiation Therapy Oncology Group (RTOG) 9714 Study. [ Time Frame: 14 weeks ]
Assessment of the patient's pain, activities and quality of life will be gathered from the patient in returning for follow-up or by contacting the patient by phone approximately 1 week following the completion of their first procedure, whether it be the vertebral augmentation or the radiotherapy (5 - 10 days following). Mandatory assessments include:
- Worst Pain Score - Brief Pain Inventory (BPI) - The Worst Pain Assessment on the Brief Inventory Scale is an assessment tool of current pain intensity and pain intensity within the last 24 hours when not on pain control medications. 0 being no pain and 10 is the worst pain possible. See protocol attachments
- Activity Level Assessment From the Roland Morris Questionnaire (RDQ) and Karnofsky Performance Status (KPS) [ Time Frame: 14 weeks ]
Roland-Morris Disability Questionnaire - The score of the RDQ is the total number of items checked - i.e. from a minimum of 0 (best) to a maximum of 24 (worst).
Karnofsky Performance Status (KPS) - scale from 10 (moribund, fatal processes progressing rapidly) to 100 (normal, no complaints, no evidence of disease).
- Quality of Life Assessment From the EORTC QLQ C30 Questionnaire. [ Time Frame: 14 weeks ]
EORTC QLQ-C30 (version 3) - The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items.
Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.
Thus a high score for a functional scale represents a high / healthy level of functioning,a high score for the global health status / QoL represents a high QoL,but a high score for a symptom scale / item represents a high level of symptomatology / problems.
- Fracture Rates Detected From X-rays. [ Time Frame: 14 weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02376933
|United States, Arizona|
|University of Arizona|
|Tucson, Arizona, United States, 85724|
|Principal Investigator:||Krisha Howell, MD||University of Arizona Radiation Oncology|