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PI left the department; protocol transfer did not take place.
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Vertebral augmentation with radiotherapy to increase the functional status and quality of life for patients with vertebral body metastatic cancers.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vertebroplasty with Radiotherapy | Experimental | Vertebroplasty with Radiotherapy is given in either order. Radiotherapy dosage is at the discretion of the treating physician. Vertebroplasty is applied to fractured vertebrae. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vertebroplasty | Procedure | Under imaging guidance, a fractured vertebral body is stabilized with injected bone cement. |
|
| 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 |
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Krisha Howell, MD | University of Arizona Radiation Oncology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arizona | Tucson | Arizona | 85724 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Vertebroplasty: Under imaging guidance, a fractured vertebral body is stabilized with injected bone cement. Radiotherapy: Radiotherapy of metastatic lesions to the spine. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Vertebroplasty: Under imaging guidance, a fractured vertebral body is stabilized with injected bone cement. Radiotherapy: Radiotherapy of metastatic lesions to the spine. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Study terminated when PI left institution; data not collected. | Posted | 14 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Vertebroplasty: Under imaging guidance, a fractured vertebral body is stabilized with injected bone cement. Radiotherapy: Radiotherapy of metastatic lesions to the spine. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrointestinal - other | Gastrointestinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Program Coordinator | University of Arizona Cancer Center | 520-626-0301 | aselegue@email.arizona.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 29, 2015 | Aug 2, 2018 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D009101 | Multiple Myeloma |
| D016103 | Spinal Fractures |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D054854 | Vertebroplasty |
| D058498 | Kyphoplasty |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D060826 | Cementoplasty |
| D019637 | Orthopedic Procedures |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
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| Radiotherapy | Radiation | Radiotherapy of metastatic lesions to the spine. |
|
| 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 |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Vertebroplasty with Radiotherapy is given in either order. Radiotherapy dosage is at the discretion of the treating physician. Vertebroplasty is applied to fractured vertebrae.
Vertebroplasty: Under imaging guidance, a fractured vertebral body is stabilized with injected bone cement.
Radiotherapy: Radiotherapy of metastatic lesions to the spine.
|
| Secondary | 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). | Study terminated when PI left institution; data not collected. | Posted | 14 weeks |
|
|
| Secondary | 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. | Study terminated when PI left institution; data not collected. | Posted | 14 weeks |
|
|
| Secondary | Fracture Rates Detected From X-rays. | Study terminated when PI left institution; data not collected. | Posted | 14 weeks |
|
|
| 1 |
| 10 |
| 2 |
| 10 |
| 5 |
| 10 |
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
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| Flu-like syndrome | General disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Pain | General disorders | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
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| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D013124 | Spinal Injuries |
| D019567 | Back Injuries |
| D014947 | Wounds and Injuries |
| D050723 | Fractures, Bone |