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Vertebral Augmentation and Radiotherapy of Collapse Spinal Metastatic Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
University of Arizona

Study Description
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Brief Summary:
Vertebral augmentation with radiotherapy to increase the functional status and quality of life for patients with vertebral body metastatic cancers.

Condition or disease Intervention/treatment Phase
Metastatic Cancers Multiple Myeloma Vertebral Fracture Procedure: Vertebroplasty Radiation: Radiotherapy Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.
 Procedure: Vertebroplasty
Under imaging guidance, a fractured vertebral body is stabilized with injected bone cement.
Other Name: kyphoplasty

Radiation: Radiotherapy
Radiotherapy of metastatic lesions to the spine.


Outcome Measures
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Primary Outcome Measures :
  1. 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



Secondary Outcome Measures :
  1. 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).


  2. 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.


  3. Fracture Rates Detected From X-rays. [ Time Frame: 14 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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): NCT02376933


Locations
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United States, Arizona
University of Arizona
Tucson, Arizona, United States, 85724
Sponsors and Collaborators
University of Arizona
Investigators
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Principal Investigator: Krisha Howell, MD University of Arizona Radiation Oncology
  Study Documents (Full-Text)

Documents provided by University of Arizona:
Study Protocol  [PDF] October 29, 2015

More Information
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Responsible Party: University of Arizona
ClinicalTrials.gov Identifier: NCT02376933    
Other Study ID Numbers: 1300000562
First Posted: March 3, 2015    Key Record Dates
Results First Posted: November 7, 2018
Last Update Posted: November 7, 2018
Last Verified: November 2018
Keywords provided by University of Arizona:
vertebral bodies
vertebral fracture
vertebral augmentation
 radiotherapy
vertebroplasty
kyphoplasty
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasm Metastasis
Neoplasms
Neoplasms, Second Primary
Spinal Fractures
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
 Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Fractures, Bone
Wounds and Injuries
Neoplastic Processes
Pathologic Processes
Spinal Injuries
Back Injuries