Phase 2 Study of Vertebral Augmentation and Radiotherapy in Painful or at Risk of Collapse Spinal Metastatic Cancer/Multiple Myeloma
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Pain Assessment From the Worst Pain Score on Brief Pain Inventory as Compared to Historical Radiation Therapy Oncology Group (RTOG) 9714 Study.
研究概览
简要总结
Vertebral augmentation with radiotherapy to increase the functional status and quality of life for patients with vertebral body metastatic cancers.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Spinal Cord Compression
研究组 & 干预措施
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.
干预措施: Vertebroplasty (Procedure)
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.
干预措施: Radiotherapy (Radiation)
结局指标
主要结局
Pain Assessment From the Worst Pain Score on Brief Pain Inventory as Compared to Historical Radiation Therapy Oncology Group (RTOG) 9714 Study.
时间窗: 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
次要结局
- Fracture Rates Detected From X-rays.(14 weeks)
- Activity Level Assessment From the Roland Morris Questionnaire (RDQ) and Karnofsky Performance Status (KPS)(14 weeks)
- Quality of Life Assessment From the EORTC QLQ C30 Questionnaire.(14 weeks)