- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02376933
Vertebral Augmentation and Radiotherapy of Collapse Spinal Metastatic Cancer
Phase 2 Study of Vertebral Augmentation and Radiotherapy in Painful or at Risk of Collapse Spinal Metastatic Cancer/Multiple Myeloma
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Arizona
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Tucson, Arizona, United States, 85724
- University of Arizona
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
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Under imaging guidance, a fractured vertebral body is stabilized with injected bone cement.
Other Names:
Radiotherapy of metastatic lesions to the spine.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 |
14 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Activity Level Assessment From the Roland Morris Questionnaire (RDQ) and Karnofsky Performance Status (KPS)
Time Frame: 14 weeks
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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). |
14 weeks
|
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. |
14 weeks
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Fracture Rates Detected From X-rays.
Time Frame: 14 weeks
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14 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Krisha Howell, MD, University of Arizona Radiation Oncology
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Fractures, Bone
- Wounds and Injuries
- Hematologic Diseases
- Hemorrhagic Disorders
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Neoplastic Processes
- Spinal Injuries
- Back Injuries
- Neoplasms
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Neoplasm Metastasis
- Spinal Fractures
- Neoplasms, Second Primary
Other Study ID Numbers
- 1300000562
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Fred Hutchinson Cancer Research Center/University...National Cancer Institute (NCI)CompletedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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Mayo ClinicCompletedMultiple Myeloma | Stage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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National Cancer Institute (NCI)TerminatedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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National Cancer Institute (NCI)CompletedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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City of Hope Medical CenterCompletedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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University of WashingtonNational Cancer Institute (NCI)TerminatedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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Fred Hutchinson Cancer CenterNational Cancer Institute (NCI)CompletedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
Clinical Trials on Vertebroplasty
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Centre Leon BerardTerminated
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University of BernSonnenhof Hospital, BernTerminatedOsteoporosis | Vertebral FractureSwitzerland
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Centre Leon BerardTerminatedSolid Tumors | Spine MetastasisFrance
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Li MinRecruiting
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Spine Centre of Southern DenmarkRecruitingMultiple Myeloma | Vertebral FractureDenmark
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Optimus Clinical ResearchCareFusionCompletedVertebral Compression Fractures | Osteoporotic Vertebral Compression Fractures | Acute Vertebral FracturesAustralia
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McGill University Health Centre/Research Institute...UnknownPain | Breast Cancer | Prostate Cancer | Vertebral MetastasisCanada
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Spine Centre of Southern DenmarkRecruitingVertebral Fracture | Osteoporotic FracturesDenmark
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University Hospital of PatrasSt. Andrew's General Hospital, Patras, GreeceCompletedThoracic Fracture | Lumbar Fracture
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Centre Hospitalier Universitaire de NiceCompletedVertebral Fracture | Vertebral TraumaFrance