Phase IV Trial Evaluating the Use of Stereotactic Body Radiotherapy for the Treatment of Spine Metastases and Primary Spine Tumors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Initial Symptom Control
研究概览
简要总结
This study will evaluate the local control rate as well as acute and late toxicity rates of stereotactic body radiotherapy (SBRT) for the treatment of spine metastases and benign spine tumors.
详细描述
This study is a single site, non-randomized, prospective, phase IV trial. Patients are composed of 2 groups:Spine Metastases OR Benign Spine Tumors. Data collected will include patient demographics, pathology data, tumor stage, SBRT dose fractionation scheme, dose received by adjacent critical normal tissues, tumor recurrence data, and acute and late toxicities.
Follow up data will be collected during the patient's standard office visits. The anticipated duration of this study is 5 years
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Eligibility Criteria:
- •Patient age >= 18 years
- •performance status of 0-3
- •Vertebral and/or paraspinal metastases, with or without prior surgery and/or fractionated radiotherapy
- •Benign extradural spine tumors such as chordomas, meningiomas, schwannomas, neurofibromas, paragangliomas, and arteriovenous malformations (AVMs).
- •Established histologic diagnosis of a benign or malignant tumor of the spine.
- •Arteriovenous malformation of the spine identified radiographically (no biopsy)
- •Well-defined lesion involving no more than 2 adjacent vertebral levels or spinal segment
- •Minimal spinal canal compromise that is not rapidly progressive. Ideally, the tumor should not be within 5 mm of the spinal cord.
- •If chemotherapy is planned, ideally it should not have been given within 30 days of starting radiation and should not resume until at least 2 weeks after completing radiation. In addition, it is not recommended to perform SBRT when targeted anti-angiogenesis therapy is planned within 2 months of the procedure.
- •Signed study-specific consent form
排除标准
- •Lesion involving > 3 adjacent vertebral levels
- •Overt spinal instability
- •Neurologic deficit due to bony fragments/bony compression of neural structures
- •Prior radiotherapy at the involved level(s) within 3 months of radiosurgery, more than one prior course of radiotherapy at the involved level(s), or more than 45 Gy previous radiation exposure at the involved level(s)
- •Rapidly progressive spinal cord compromise or neurological deficit
- •Paralysis, or otherwise compromised motor function due to radiographically confirmed cord compression
- •Patient unable to undergo an MRI
- •Pregnant or lactating women, due to potential exposure of the fetus to RT and unknown effects of RT on lactating females
- •Patients with psychiatric or addictive disorder that would preclude obtaining informed consent
研究组 & 干预措施
SBRT for Benign Extradural Spine Tumors
Benign extradural spine tumors such as chordomas, meningiomas, schwannomas, neurofibromas, paragangliomas, and arteriovenous malformations (AVMs).
干预措施: SBRT for Benign Extradural Spine Tumors (Radiation)
SBRT for Vertebral/Paraspinal Metastases
Vertebral and/or paraspinal metastases, with or without prior surgery and/or fractionated radiotherapy
干预措施: SBRT for Vertebral/Paraspinal Metastases (Radiation)
结局指标
主要结局
Initial Symptom Control
时间窗: 6 weeks post-SBRT (or at first post-treatment follow-up)
Evaluation of pain relief per patient report
Local Tumor Recurrence Rate
时间窗: (1) At 1 year post-SBRT, (2) At patient's last follow-up or time of death
Local recurrence is defined as tumor recurrence or progression within the planning target volume. Local control rate will be evaluated by imaging techniques and/or clinical symptoms (worsening or no improvement in pain or neurologic compromise). If follow-up imaging is available, a local recurrence will be defined as an increase of \> 20% in tumor size.
次要结局
- Late Toxicity Rate(at patient's last follow-up (at least 3 months from treatment) or time of death)
研究者
Juli Mai, MD
Radiation Oncology
Mercy Research