Vertebral Augmentation and Radiotherapy of Collapse Spinal Metastatic Cancer

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

Detailed Description
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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.

Official Title
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Phase 2 Study of Vertebral Augmentation and Radiotherapy in Painful or at Risk of Collapse Spinal Metastatic Cancer/Multiple Myeloma

Conditions
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Metastatic Cancers, Multiple Myeloma, Vertebral Fracture

Intervention / Treatment
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* Procedure: Vertebroplasty
* Radiation: Radiotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vertebroplasty with Radiotherapy<br>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<br>* Under imaging guidance, a fractured vertebral body is stabilized with injected bone cement.<br>* Other names: kyphoplasty;Radiation: Radiotherapy<br>* Radiotherapy of metastatic lesions to the spine.<br>|

What is the study measuring?
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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. | 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) | 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. | 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 | 
| Fracture Rates Detected From X-rays. |  | 14 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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kyphoplasty, vertebral bodies, vertebral fracture, vertebral augmentation, radiotherapy, vertebroplasty