Phase II Study of Stereotactic Body Radiation Therapy and Vertebroplasty for Localized Spinal Metastasis (SBRT Spine)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Pain Response as Measured by VAS at 3 Months
研究概览
简要总结
RATIONALE: Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Vertebroplasty may help prevent fractures and spinal cord compression caused by spinal metastasis. Giving stereotactic body radiation therapy together with vertebroplasty may help lessen pain and improve quality of life of patients with spinal metastasis.
PURPOSE: This phase II trial is studying how well giving stereotactic body radiation therapy together with vertebroplasty works in treating patients with localized spinal metastasis.
详细描述
OBJECTIVES:
Primary
- To determine the efficacy of stereotactic body radiotherapy in reducing pain at 3 months in patients with localized spinal metastasis.
Secondary
- To determine the duration of pain response at the treated site(s) scored as the time of maximal pain relief to an increase of 2 points on the Visual Analogue Scoring System.
- To determine the functional preservation of improvement as measured by the Brief Pain Inventory.
- To prospectively assess quality of life using the FACT-G and EQ-5D questionnaires.
- To determine the long-term stability of the treated vertebral bone (e.g., fracture, sclerotic change, vertebral body height, or malalignment) as measured by MRI, CT scan, and plain radiographs.
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
- 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:
- •Patients must have localized spine metastasis (a solitary spine metastasis; two contiguous levels, or up to three separate single vertebral levels are permitted)
- •Patients must have a VAS of ≥4 at any of the planned treatment sites
- •Patient with epidural, spinal nerve, and/or cord compression on MRI may be included
- •Histologic confirmation of cancer is required by biopsy, prior surgery, or re-biopsy
- •Narcotic pain prescription and usage information must be available and documented
- •Patients must sign study specific consent
- •Above the age of 18
- •For women of childbearing age a negative pregnancy test is required
- •Patients considered for the retreatment arm, must not of had prior radiation to the proposed spinal site within a 3 month interval prior to treatment
- •Zubrod score of 0-2
排除标准
- •Patients who have been non-ambulatory for more than 7 days
- •Patients with compression fractures
- •Spine instability requiring fixation
- •Patients with paraspinal extension
- •Patients with bony fragments
- •Planned systemic treatment within one week after treatment.
- •Absence of pathological diagnosis of cancer
- •Chemotherapy within one week of treatment
- •Patients with Multiple Myeloma, Lymphoma, or Plasmacytoma
- •Patient suffered from unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
- •Patient had a transmural myocardial infarction within the last 6 months
- •Patient has an acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
- •Patient has hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
- •PT is not within normal limits or planned and feasible to be corrected to normal limits prior to vertebroplasy
- •PTT is not within normal limits or planned and feasible to be corrected to normal limits prior to vertebroplasy
- •Platelet count is < 50,000
- •History of significant psychiatric illness
- •Note: Vertebroplasty may not be possible for certain patients due to tumor location or safety. In such cases, patients will omit the vertebroplasty but receive all other protocol care and follow-up Visual Analog Scoring
研究组 & 干预措施
Radiation followed by Vertebroplasty
Intervention:
This study is one arm. All patients will undergo radiotherapy followed by vertebroplasty. Patients who had prior radiotherapy will undergo 5 fractions of stereotactic body radiotherapy (SBRT) over 30-90 minutes each. Patients has no prior radiotherapy will undergo 1 fraction of SBRT over 30-90 minutes. The full patient population will then undergo vertebroplasty*.
*Vertebroplasty may not be possible for certain patients due to tumor location or safety. In such cases, patients will omit the vertebroplasty but receive all other protocol care and follow-up.
干预措施: radiation (Radiation)
结局指标
主要结局
Pain Response as Measured by VAS at 3 Months
时间窗: 3 month
Pain reduction as measured by Visual Analogue Scoring System (VAS) at 3 months Patient pain was recorded on a 10-point scale (0: no pain, 10: most severe pain). At baseline patients were required to have a pain score of 4 or higher associated with spine metastases. Pain response was recorded again during follow-up visits to determine the pain response: A pain score of 0 represents a complete response A decrease in the pain score by at least 2 points represents a partial response VAS scores were used to determine the number of patients with a partial pain response, with a complete pain response, and without a pain response
次要结局
- Daily Function(Baseline)
- Pain Response(1 month)
- Overall Survival(5 year)
- Quality of Life Questionnaire Responses(12 months)
研究者
Robert Timmerman
Professor
University of Texas Southwestern Medical Center