Phase II Study of Stereotactic Body Radiation Therapy and Vertebroplasty for Localized Spinal Metastasis (SBRT Spine)
概览
- 阶段
- 2 期
- 干预措施
- 未指定
- 疾病 / 适应症
- Metastatic Cancer
- 发起方
- University of Texas Southwestern Medical Center
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Pain Response as Measured by VAS at 3 Months
- 状态
- 已完成
- 最后更新
- 4年前
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. OUTLINE: Patients are assigned to 1 of 2 treatment groups according to prior radiotherapy to the planned treatment site(s). * Group 1 (prior radiotherapy): Patients undergo 5 fractions of stereotactic body radiotherapy (SBRT) over 30-90 minutes each. * Group 2 (no prior radiotherapy): Patients undergo 1 fraction of SBRT over 30-90 minutes. Within 1 month after the initiation of SBRT, patients in both groups undergo percutaneous vertebroplasty. Patients complete pain and quality-of-life questionnaires at baseline and periodically during study. Patients also undergo MRI and CT scan at baseline, at 1, 3, and 6 months, and then every 6 months for 3 years to assess changes in vertebral bone strength and stability. After completion of study therapy, patients are followed at 2 weeks, at 1, 3, and 6 months, and then every 6 months for 3 years.
研究者
Robert Timmerman
Professor
University of Texas Southwestern Medical Center
入排标准
入选标准
- 未提供
排除标准
- 未提供
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
- Pain Response(1 month)
- Overall Survival(5 year)
- Daily Function(Baseline)
- Quality of Life Questionnaire Responses(12 months)