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Vertebral Augmentation and Radiotherapy of Collapse Spinal Metastatic Cancer

Primary Purpose

Metastatic Cancers, Multiple Myeloma, Vertebral Fracture

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vertebroplasty
Radiotherapy
Sponsored by
University of Arizona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Cancers focused on measuring vertebral bodies, vertebral fracture, vertebral augmentation, radiotherapy, vertebroplasty, kyphoplasty

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of metastatic disease to the vertebra or multiple myeloma
  • Negative pregnancy test within 2 weeks prior to registration
  • Life expectancy of >= 3 months and Karnofsky performance status (KPS) score >= 40
  • Pain scale score >=5
  • Pain at involved vertebral body not adequately controlled
  • Osteolysis of vertebral bodies
  • Must agree to practice adequate means of birth control
  • Must sign informed consent prior to study entry
  • Must be able to understand the English language
  • Absence of any serious cognitive or psychiatric problems potentially hampering compliance with the study and follow-up schedule.

Exclusion Criteria:

  • Spinal Cord Compression

Sites / Locations

  • University of Arizona

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Vertebroplasty with Radiotherapy

Arm Description

Vertebroplasty with Radiotherapy is given in either order. Radiotherapy dosage is at the discretion of the treating physician. Vertebroplasty is applied to fractured vertebrae.

Outcomes

Primary Outcome Measures

Pain Assessment From the Worst Pain Score on Brief Pain Inventory as Compared to Historical Radiation Therapy Oncology Group (RTOG) 9714 Study.
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

Secondary Outcome Measures

Activity Level Assessment From the Roland Morris Questionnaire (RDQ) and Karnofsky Performance Status (KPS)
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.
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.

Full Information

First Posted
February 20, 2015
Last Updated
November 6, 2018
Sponsor
University of Arizona
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1. Study Identification

Unique Protocol Identification Number
NCT02376933
Brief Title
Vertebral Augmentation and Radiotherapy of Collapse Spinal Metastatic Cancer
Official Title
Phase 2 Study of Vertebral Augmentation and Radiotherapy in Painful or at Risk of Collapse Spinal Metastatic Cancer/Multiple Myeloma
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Terminated
Why Stopped
PI left the department; protocol transfer did not take place.
Study Start Date
August 20, 2013 (Actual)
Primary Completion Date
August 10, 2016 (Actual)
Study Completion Date
April 7, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arizona

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Vertebral augmentation with radiotherapy to increase the functional status and quality of life for patients with vertebral body metastatic cancers.
Detailed Description
The study quantifies the reduction of pain and changes in quality of life associated with vertebral augmentation. This study is conducted in patients with metastatic cancer or multiple myeloma involving the spine. This study addresses the value of vertebral augmentation in combination with radiotherapy in the setting of cancer to the spine. The patient's pain, overall quality of life, and fracture development/avoidance will be compared to patients treated only with radiotherapy in the past.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Cancers, Multiple Myeloma, Vertebral Fracture
Keywords
vertebral bodies, vertebral fracture, vertebral augmentation, radiotherapy, vertebroplasty, kyphoplasty

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vertebroplasty with Radiotherapy
Arm Type
Experimental
Arm Description
Vertebroplasty with Radiotherapy is given in either order. Radiotherapy dosage is at the discretion of the treating physician. Vertebroplasty is applied to fractured vertebrae.
Intervention Type
Procedure
Intervention Name(s)
Vertebroplasty
Other Intervention Name(s)
kyphoplasty
Intervention Description
Under imaging guidance, a fractured vertebral body is stabilized with injected bone cement.
Intervention Type
Radiation
Intervention Name(s)
Radiotherapy
Intervention Description
Radiotherapy of metastatic lesions to the spine.
Primary Outcome Measure Information:
Title
Pain Assessment From the Worst Pain Score on Brief Pain Inventory as Compared to Historical Radiation Therapy Oncology Group (RTOG) 9714 Study.
Description
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
Time Frame
14 weeks
Secondary Outcome Measure Information:
Title
Activity Level Assessment From the Roland Morris Questionnaire (RDQ) and Karnofsky Performance Status (KPS)
Description
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).
Time Frame
14 weeks
Title
Quality of Life Assessment From the EORTC QLQ C30 Questionnaire.
Description
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.
Time Frame
14 weeks
Title
Fracture Rates Detected From X-rays.
Time Frame
14 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of metastatic disease to the vertebra or multiple myeloma Negative pregnancy test within 2 weeks prior to registration Life expectancy of >= 3 months and Karnofsky performance status (KPS) score >= 40 Pain scale score >=5 Pain at involved vertebral body not adequately controlled Osteolysis of vertebral bodies Must agree to practice adequate means of birth control Must sign informed consent prior to study entry Must be able to understand the English language Absence of any serious cognitive or psychiatric problems potentially hampering compliance with the study and follow-up schedule. Exclusion Criteria: Spinal Cord Compression
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Krisha Howell, MD
Organizational Affiliation
University of Arizona Radiation Oncology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arizona
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States

12. IPD Sharing Statement

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Vertebral Augmentation and Radiotherapy of Collapse Spinal Metastatic Cancer

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