Phase I/II Evaluation of Single Session Stereotactic Body Radiotherapy for Spinal or Paraspinal Metastases
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 2
- 主要终点
- Complete Pain Relief Using Stereotactic Body Radiotherapy (SBRT) to Treat Spine and Para- Spinal Tumors in a Single Session
研究概览
简要总结
The goal of this clinical research study is to find out if stereotactic body radiotherapy to the spine using computerized tomography (CT)-on-Rails is safe and effective in the treatment of metastatic spine tumors.
Objectives:
- Establish the safety and efficacy of using stereotactic body radiotherapy (SBRT) to treat spine and para-spinal tumors in a single session.
- Document frequency and severity of pain, symptoms and symptom interference, as well as quality of life before and after treatment.
- Document changes in neurological function at defined intervals compared to pre-treatment neurological function.
详细描述
CT-on-Rails 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 before registration on this study. You will also fill out a health survey, a symptom inventory, and a Brief Pain Inventory within 1 week before registration. Each of these surveys should take about 5 minutes to complete. You will have a CT-simulation. The simulation is like a CT scan where a special body frame is used to keep you from moving during scanning and later radiation treatment. However, no radiation is delivered during the simulation. You will be asked questions about your medical history and have a complete neurological exam during your first consultation, before registration. The neurological exam involves testing upper and lower motor strength, sensation to light touch, reflexes, a mental exam, and an evaluation of the way you walk.
Radiation treatment will last between 2 and 2 1/2 hours and will be given on 1 day about 1 to 1 1/2 weeks after you had the simulation. You will have a device (similar to plastic wrap) placed around you that will hold you still during the treatment. You will be checked for level of pain and/or discomfort before starting each session of radiation, and you may take pain medications before starting each session. All participants will be treated with radiation therapy that is guided by the CT-on-Rails procedure. On the day of radiation, you will also receive a CT scan using CT-on-Rails in the same treatment room, immediately before the radiation treatment.
During treatment, a physician will be monitoring you for any side effects. If you experience severe side effects, radiation treatment will be stopped, and you will be taken off study. After treatment on this study ends, you will have telephone, mail, or facsimile (Fax) follow-ups scheduled at 1, 2, 3, 4, and 8 weeks after radiation. You will be asked questions about any side effects or pain you are experiencing and any other therapies you may have started.
You will have follow-up visits scheduled at 3, 6, 9, 12, 18, and 24 months and then every 6 months for the rest of your life. At all follow-up visits, you will be asked questions about your medical history, have a neurological exam, and your neurologic function will be evaluated. Any pain medication you are taking will be noted. You will be asked to have a MRI of the spine at 3, 6, 9, 12,18, and 24 months, then once a year for the rest of your life. You will also be asked to complete 3 questionnaires to evaluate your symptoms, pain, and quality of life at each follow-up visit. Each questionnaire should take around 5 minutes to complete.
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 weeks of registration
- •Maximum of 2 metastatic sites in the spine to be irradiated in single session
- •Informed consent for irradiation of spinal or para-spinal tumor (s)
- •Diagnosis of cancer including but not limited to lung (non-small cell and small cell), breast, prostate, renal cell, melanoma, gastrointestinal, and germ cell tumors, unknown primary tumors
- •Karnofsky performance status of at least 40 (ie not requiring active hospitalization)
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
- •Prior irradiation to current site of interest in the spine
- •Spinal metastasis in the cervical spine are not eligible for treatment
- •Unstable spine requiring surgical stabilization.
- •Sites outside the spine (eg. lung, liver) are not eligible for treatment
- •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
结局指标
主要结局
Complete Pain Relief Using Stereotactic Body Radiotherapy (SBRT) to Treat Spine and Para- Spinal Tumors in a Single Session
时间窗: Six months after completion of radiation therapy
To measure 6-month complete pain relief, i.e., 6-month "pain worst" from the BPI being zero
Local Tumor Control Rate
时间窗: local tumor control rate, the time frame is up to 48 months
Local tumor control rate as measured based on spinal MRI showing absence of progression
Paralysis (Grade 4 Motor Neuropathy)
时间窗: Up to 24 months after radiation therapy
Evidence of paralysis (Grade 4 motor neuropathy) casued by radiation myelitis
次要结局
未报告次要终点