A Phase I/II Dose Escalation Study to Evaluate Pain Response Using Extracranial Stereotactic Radiosurgery to Treat Paraspinal Metastasis in Patients Who Have Received Prior Spinal Irradiation
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Optimal Dose of Stereotactic Spinal Irradiation Needed to Obtain Durable Pain Control at 4 Weeks in a Previously Irradiated Spine Field
研究概览
简要总结
This study will evaluate pain control and quality of life in patients with paraspinal metastases, who have receive previous radiation therapy to these lesions, using single dose stereotactic radiotherapy.
详细描述
The goal of the study is to determine the lowest dose of radiation that can be given to effectively control the tumor and provide effective pain relief.
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
- •Prior non-hematogenous, histologically proven malignancy (specific exclusions are multiple myeloma and lymphoma)
- •Pain attributable to one or two radiographically apparent metastatic lesion(s) amenable to ESRT
- •Have had prior radiation to area of spine felt to be cause of patient's pain
- •Zubrod performance status of 0-3
- •Life expectancy of ≥ 3 months
- •Signed informed consent prior to registration to study
- •Radiographic evidence of stable disease outside of the spinal column for at least 6 weeks prior to study entry, as evaluated by pre-study imaging.
排除标准
- •Women who are pregnant or nursing
- •Either 'no evidence of other active cancerous disease' or 'other sites of known disease are locally controlled'
- •No radiographic evidence of spinal instability (e.g. spinal cord compression requiring immediate surgical intervention)
- •No initiation of chemotherapy within 15 days of trial entry.
- •No plans for concomitant antineoplastic therapy (including standard fractionated RT, chemotherapy, biologic, vaccine therapy, or surgery) for at least 15 days following stereotactic radiosurgery.
- •No active systemic infection.
- •No evidence of myelopathy or cauda equina syndrome on clinical evaluation
研究组 & 干预措施
Group 3
1600 cGY radiation
干预措施: Stereotactic radiotherapy (Radiation)
Group -1
1000 cGY radiation
干预措施: Stereotactic radiotherapy (Radiation)
Group 2
1400 cGY radiation
干预措施: Stereotactic radiotherapy (Radiation)
Group 1
1200 cGY radiation
干预措施: Stereotactic radiotherapy (Radiation)
结局指标
主要结局
Optimal Dose of Stereotactic Spinal Irradiation Needed to Obtain Durable Pain Control at 4 Weeks in a Previously Irradiated Spine Field
时间窗: 4 weeks
Optimal dose 1. the maximum tolerated dose (MTD) that will result in a 10% ESRT-induced neurological complications 2. the minimal dose level that can achieve an 80% or more pain control rate, whichever occurs first
次要结局
- Determine the Rate of Radiation-induced Myelopathy From Stereotactic Re-irradiation of the Spinal Metastases.(4 weeks)
- Duration of Pain Control for Each Dose Level.(4 years)
- Determine the Pattern of Failure After Stereotactic Irradiation of Spinal Metastases.(4 years)
- Quality of Life(4 years)