Phase I/II Evaluation of a Novel CT-On-Rails or Trilogy Stereotactic Spine Radiotherapy System (SSRS) for the Treatment of Metastatic Spine Disease
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Patient Response (Pain Relief)
研究概览
简要总结
The goal of this clinical research study is to find out if stereotactic spine radiotherapy is safe and effective in the treatment of metastatic spine tumors. The feasibility of this type of treatment will be studied as will any side effects related to the treatment. The precision and accuracy of the CT-on-rails will also be studied.
详细描述
CT-On-Rails or Trilogy is a system that places the radiation treatment machine in the same room as the CT scanner so that the CT scanner can help deliver radiation more precisely.
You will have a MRI of the spine within 1 month of registration on this study. You will also fill out a health survey (5 minutes), a symptom inventory ( 5 minutes), and a Brief Pain Inventory (5 minutes) within 1 week of registration.
A pretreatment feasibility study will first be performed to determine the precision, accuracy, and reproducibility with which the target volume and critical normal structures (e.g. spinal cord) can be positioned relative to the radiation beams for spine tumors; this will consist of a CT scan.
Patients will have a CT-simulation. The simulation is like a CT scan where a special body frame is used to keep the patient from moving during scanning and later treatment.
You will be asked questions about your medical history and have a complete neurological exam during your first consultation. The neurological exam involves testing upper and lower motor strength, sensation to light touch, reflexes, mental exam, and way you walk. MRI of the spine must be performed within 1 month of registration. You will be asked to complete 3 questionnaires to evaluate your symptoms and pain. Each questionnaire will take around 5 minutes to complete, and should be completed within 1 month of being enrolled in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Radiographically documented spine or paraspinal metastasis demonstrated on spine MRI within 4 wks of registration
- •Maximum of 2 metastatic sites in the spine to be irradiated over a single course of treatment.
- •Informed consent for irradiation or re-irradiation of spinal or para-spinal tumor (s)
- •Diagnosis cancer including but not limited to lung (non-small cell and small cell), breast, prostate, renal cell, melanoma, gastrointestinal, germ cell tumors, and unknown primary tumors
- •Karnofsky performance status of at least 40 (i.e. not requiring active hospitalization)
- •Maximum of 1 prior course of spine radiotherapy to the current region of interest allowed.
排除标准
- •Worsening neurological status due to radiographic evidence of spinal cord compression requiring immediate surgical decompression or emergent conventional external radiation therapy
- •Delay in initiation of radiation treatment would be potentially detrimental to neurological outcome
- •Patients already re-treated with radiation as part of this protocol will not be eligible for additional re-treatment
- •Unstable spine requiring surgical stabilization.
- •Sites outside the spine (eg. lung, liver) are not eligible for treatment
- •Systemic radiotherapy (Sr-89) within 30 days
- •Prior irradiation of the area to be treated within 3 months of registration
- •Patients currently receiving, or who have received chemotherapy within 30 days are not eligible
- •Inability to tolerate lying flat on treatment couch for greater than 30 minutes.
- •Patient with multiple myeloma
- •Patients unable to undergo MRI of the spine
- •Patients with pacemakers
- •Patients who have previously received maximum cord tolerance of 45 Gy in 5 weeks conventional fractionation or equivalent dose to the current area to be treated.
研究组 & 干预措施
Radiation Therapy
Radiation Therapy using CT-on-Rails or Trilogy procedure. Participants prescribed to receive 9 Gy x 3 so that a peripheral dose of 27 Gy is given to the tumor.
干预措施: Radiation Therapy (Radiation)
结局指标
主要结局
Patient Response (Pain Relief)
时间窗: Baseline, 3, 6, 9, 12, 18, and 24 months, then every six months
The validated Brief Pain Inventory (BPI), MD Anderson Symptom Inventory (MDASI), and SF-12v2 Health Survey used to assess changes in these indicators compared to pre-treatment baseline. Response determined by follow-up questionaires. Time to maximal pain relief is the time from the first day of irradiation until the lowest pain score for average pain after radiotherapy. The "worst pain score" from BPI used as the marker for treatment success or failure.
次要结局
未报告次要终点