Prophylactic Cement Augmentation for Patients at High Risk for Developing Vertebral Body Compression Fracture Following Spine Stereotactic Radiosurgery: A Randomized Phase II Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 87
- 试验地点
- 1
- 主要终点
- Vertebral compression fracture rate
研究概览
简要总结
This randomized phase II trial studies how well cement augmentation works in preventing vertebral body compression fracture following spine stereotactic radiosurgery in patients with solid tumors that have spread to the spine. Spine stereotactic radiosurgery delivers a high dose of radiation to vertebral metastases and can sometimes lead to a vertebral compression fracture. Using body cement on the largest part of the vertebra (a procedure called vertebral body cement augmentation) may help prevent a fracture after stereotactic spinal radiosurgery. It may also lessen pain and improve quality of life in patients with solid tumors and spinal metastases undergoing this surgery.
详细描述
PRIMARY OBJECTIVES:
I. To assess whether prophylactic cement augmentation reduces new or progressive vertebral body fracture at 3 months in high risk patients undergoing single fraction spine stereotactic radiosurgery.
SECONDARY OBJECTIVES:
I. To assess the impact of prophylactic cement augmentation on time to first new or progressive vertebral body fracture.
II. To assess the impact of prophylactic cement augmentation on pain control measured every three months post treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •All patients must have histologic proof of solid tumor malignancy and radiographic evidence of spine metastasis
- •Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)
- •Life expectancy of greater than 3 months
- •All patients must be able to lie supine
- •All patients must have no more than 3 contiguous vertebral body levels treated at a single site, and no more than 3 discontiguous vertebral body levels treated
- •All patients must have a single fraction spine radiosurgery at the designated site of interest to at least a dose of 18 Gray (Gy)
- •All patients must be deemed at "high risk" of developing vertebral body fracture by having at least one of the following characteristics:
- •Spine Instability Neoplastic Score classification of "Indeterminate" deemed as a score from 7 to 12
- •Pre-existing vertebral body fracture
- •Planned radiation dose of 24 Gy
- •All patients must have a vertebral body site to be treated located from T1 to L5
- •Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
- •All patients must sign informed consent verifying that they are aware of the investigational nature of this study in keeping with the rules and policies of M.D. Anderson Cancer Center; the only acceptable consent is the one approved by M.D. Anderson Institutional Review Board (IRB)
- •Patients undergoing bisphosphonate therapy are allowed
排除标准
- •Patients who have had prior radiotherapy at the spine site and level to be treated
- •Patients who have had prior surgery at the spine level to be treated to include prior cement augmentation, laminectomy, vertebrectomy, tumor debulking, instrumentation
- •Patients with gross disease involving only the posterior elements
- •Patients who have > 50% vertebral body collapse
- •Patients unable to undergo magnetic resonance imaging (MRI) of the spine
- •Patents with cord compression
- •Patients deemed not be a candidate for cement augmentation for any reason
- •Patients who have frank mechanical pain
- •Patients with both pedicles involved with gross disease at the level of potential cement augmentation
- •Pregnant women are excluded from this study
- •Patients with a histology of lymphoma, myeloma and small cell lung cancer histologies
研究组 & 干预措施
Arm I (standard of care)
Patients undergo stereotactic spinal radiosurgery per standard of care.
干预措施: Quality-of-Life Assessment (Other)
Arm I (standard of care)
Patients undergo stereotactic spinal radiosurgery per standard of care.
干预措施: Questionnaire Administration (Other)
Arm I (standard of care)
Patients undergo stereotactic spinal radiosurgery per standard of care.
干预措施: Stereotactic Radiosurgery (Radiation)
Arm II (vertebral body cement augmentation)
Patients undergo vertebral body cement augmentation within 4 weeks before or after standard stereotactic spinal radiosurgery.
干预措施: Management of Therapy Complications (Procedure)
Arm II (vertebral body cement augmentation)
Patients undergo vertebral body cement augmentation within 4 weeks before or after standard stereotactic spinal radiosurgery.
干预措施: Quality-of-Life Assessment (Other)
Arm II (vertebral body cement augmentation)
Patients undergo vertebral body cement augmentation within 4 weeks before or after standard stereotactic spinal radiosurgery.
干预措施: Questionnaire Administration (Other)
Arm II (vertebral body cement augmentation)
Patients undergo vertebral body cement augmentation within 4 weeks before or after standard stereotactic spinal radiosurgery.
干预措施: Stereotactic Radiosurgery (Radiation)
结局指标
主要结局
Vertebral compression fracture rate
时间窗: At 3 months
Will compare the 3-month vertebral compression fracture proportions between treatment groups using the Fisher exact test. Will be performed on the intention-to-treat principle.
次要结局
- Pain control, assessed using the Brief Pain Inventory form(Up to 2 years)
- Quality of life, assessed using the MD Anderson Symptom Inventory-Spine Tumor form(Up to 2 years)
- Local control(Up to 2 years)
- Overall survival(Up to 2 years)
- Incidence of post-treatment adverse events(Up to 2 years)
- Radiographic vertebral body fracture, pain control and quality of life assessment(Up to 2 years)
- Time to first new or progressive vertebral body fracture(Up to 2 years)
- Quality of life, assessed using the EuroQol 5-dimensional 5-level questionnaire.(Up to 2 years)