Phase II Cohort of Spinal Stereotactic Radiotherapy in Patients Using a MR LINAC
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- M. D. Anderson Symptom Inventory - Spine Tumor (MDASI-SP) questionnaires
研究概览
简要总结
To learn whether giving spinal stereotactic radiosurgery (SRSS) that uses a more advanced imaging scan method called Magnetic Resonance imaging with a Linear Accelerator (MR-LINAC) during treatment will lead to improved responses to treatment and better quality of life. SRSS is radiation therapy given to the area around your spine.
详细描述
Primary objective:
• To determine the 6-month local control (LC) of the target site of treatment.
Secondary Objectives:
- To determine the 6-month change in epidural tumor volume (by volumetric measurements where applicable)
- To determine the 1-year local control of the target site
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •Age ≥ 18 years old
- •Radiographically documented disease of the spine within 4 weeks of registration (candidates with or without epidural disease allowed)
- •Candidate for spine SRS/SBRT as determined by treating Radiation Oncologist or Multidisciplinary Spine Conference review
- •Maximum of 3 contiguous vertebral levels involved with metastasis in the spine to be irradiated allowed
- •Diagnosis of cancer documented
- •Motor strength ≥ 4 out of 5 in the extremity affected by the level of spinal disease planned for radiation
- •Karnofsky Performance score (KPS) ≥ 40 or ECOG score ≤ 3
排除标准
- •Patients with highly radiosensitive histologies likely to respond to conventional radiation therapy alone (ie lymphoma, multiple myeloma, etc)
- •Patients who are unable to undergo MRI of the spine with contrast
- •Patients who are pregnant
研究组 & 干预措施
Group 1 (Therapeutic Cohort)
Participants in Group 1 will receive spine radiosurgery on the MR LINAC machine, along with imaging scans using the same machine.
干预措施: Spine Radiosurgery (Procedure)
Group 1 (Therapeutic Cohort)
Participants in Group 1 will receive spine radiosurgery on the MR LINAC machine, along with imaging scans using the same machine.
干预措施: Magnetic Resonance imaging (Device)
Group 2 (Imaging-only Cohort)
Participants in Group 2 will receive spine radiosurgery using a standard radiation therapy machine and have the opportunity to get imaging on the MR LINAC.
干预措施: Spine Radiosurgery (Procedure)
Group 1 (Therapeutic Cohort)
Participants in Group 1 will receive spine radiosurgery on the MR LINAC machine, along with imaging scans using the same machine.
干预措施: MR-LINAC (Radiation)
Group 2 (Imaging-only Cohort)
Participants in Group 2 will receive spine radiosurgery using a standard radiation therapy machine and have the opportunity to get imaging on the MR LINAC.
干预措施: Magnetic Resonance imaging (Device)
结局指标
主要结局
M. D. Anderson Symptom Inventory - Spine Tumor (MDASI-SP) questionnaires
时间窗: through study completion; an average of 1 year
M. D. Anderson Symptom Inventory - Spine Tumor (MDASI-SP) 0 (symptom has not been present) to 10 (the symptom was as bad as you can imagine it could be) for each item.
次要结局
未报告次要终点