NCT02225223终止不适用
Evaluation of Targeted Radiofrequency Ablation and Vertebral Augmentation Prior to or Following Radiation Therapy to Treat Painful Metastatic Vertebral Body Tumor(s) [The STARRT Study]
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 35
- 试验地点
- 28
- 主要终点
- Mean Change From Baseline in Brief Pain Inventory Q3 Worst Pain Score at 6 Weeks
研究概览
简要总结
The purpose of this study is to evaluate treating painful metastatic lesions in vertebral bodies with pathologic fractures with targeted radiofrequency ablation (t-RFA) and vertebral augmentation (VA) prior to or following radiation therapy.
详细描述
Prospective, multi-center clinical study. Stratification scheme: 'Failed/Refused Further RT' and "No Previous RT"
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Male or female patient is ≥ 18 years old,
- •One to two painful vertebrae (T1-L5) with evidence of osteolytic or mixed lytic and blastic metastatic lesion by cross sectional imaging and pathologic fracture (presence of non-painful vertebrae with metastatic lesions in addition to the painful index vertebrae are allowed)
- •Never received radiation therapy at index level(s) (following consult with radiation oncologist re: conventional treatment options) OR Received radiation therapy without adequate relief from metastatic bone pain as determined by the patient and treating physician, their treating physician would not prescribe additional radiation treatments, or refuse additional radiation therapy,
- •Brief Pain Inventory (BPI) worst pain score of ≥ 4 (irrespective of medication),
- •Woman of potential childbearing age agrees to a medically effective birth control method,
- •Life expectancy of ≥ 2 months,
- •Sufficient mental capacity to comply with the protocol requirements,
- •Understands the potential risks and benefits of study participation and is willing to provide written informed consent.
排除标准
- •Primary tumors of the bone (e.g., osteosarcoma) at site of index vertebra(e),
- •Benign tumors of the bone (e.g. osteoid osteoma) at site of index vertebra (e),
- •Lesions due to hematologic malignancy (e.g. multiple myeloma at site of the index vertebra (e),
- •Compromise in the posterior column of the vertebral body or walls of pedicles.
- •Extra-osseous extension of metastatic lesion is >10mm,
- •Nonreversible or uncorrectable coagulopathy. INR should not be >1.5,
- •Platelet count of < 50,000 ,
- •Radiation therapy was completed on the index vertebra(e) ≤ 28 days before enrollment,
- •Change in chemotherapy agent is planned 7 days before or after enrollment (change in dose(s) permitted),
- •Index vertebra(e) had previous spine surgery including vertebroplasty or kyphoplasty,
- •Additional non-kyphoplasty/vertebroplasty surgical treatment is required for the index vertebra(e),
- •Spinal cord compression or canal compromise requiring decompression,
- •Major surgery of the spine in same region as the index vertebra(e) was performed within 3 months before enrollment,
- •Major elective surgery to the spine in same region as the index vertebra(e) is planned within 1 month following the ablation and cement procedure,
- •Requires upper and lower limb surgery that will affect functional outcomes,
- •Significant clinical morbidities (aside from the index vertebra(e) and recurrent cancer) that may interfere with data collection that affects pain and functional results,
- •Medical/surgical conditions contrary to the kyphoplasty procedure (e.g., presence of active or incompletely treated local infection, severe pulmonary insufficiency),
- •Bedridden due to paralysis or neurological decline,
- •Currently pregnant or nursing, or planning pregnancy (in the period up to 6 months) following the index procedure(s),
- •Known allergy to bone cement,
- •Has a heart pacemaker or other electronic device implants
- •Concurrent participation or participation within the last 30 days prior to enrollment in any clinical trial with an investigational medicinal drug/chemotherapeutic or biologic or medical product.
结局指标
主要结局
Mean Change From Baseline in Brief Pain Inventory Q3 Worst Pain Score at 6 Weeks
时间窗: Mean change from baseline to 6 weeks
The Brief Pain Inventory (BPI) short form rates pain on a scale from 0 to 10 (with 0=no pain and 10=worst pain you can imagine). The response is from Q3 reporting worst pain within the last 24 hours. Primary outcome is measuring the mean change from baseline in BPI worst pain score at 6 weeks.
次要结局
- Mean Change From Baseline in Brief Pain Inventory Worst Pain Score at Visits Prior to 6 Weeks(Mean Change from Baseline prior to 6 weeks)
- Brief Pain Inventory Q3 Worst Pain Score by Visit(Week 1, Week 2, Week 6)
研究者
研究点 (28)
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