Cyberknife Radiosurgery for Improving Palliation of Metastatic Tumors of the Spine
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Maximum tolerated dose - hypofraction
研究概览
简要总结
RATIONALE: Stereotactic radiosurgery can send x-rays directly to the tumor and cause less damage to normal tissue. It may also help patients with spinal metastases live more comfortably.
PURPOSE: This phase I trial is studying the side effects and best dose of stereotactic radiosurgery in treating patients with spinal metastases.
详细描述
OBJECTIVES:
- To implement CyberKnife® technology for improving palliation in patients with spinal metastases.
- To determine the maximum tolerated dose of CyberKnife® hypofractionated stereotactic radiosurgery in these patients.
- To evaluate functional and diffusion MRI parameters in the spinal cord and tumor after treatment with Cyberknife® radiosurgery.
OUTLINE: Patients undergo placement of gold fiducial markers at the time of open surgical resection or percutaneous needle biopsy. Patients then undergo CyberKnife® hypofractionated stereotactic radiosurgery over 30-90 minutes daily for 2-3 days.
Patients undergo functional MRI and diffusion tensor imaging at baseline and then at 6 weeks and 6 months after completion of treatment. Patients also complete a pain questionnaire at baseline and then at 3, 6, 9, 12, 18, and 24 months after completion of treatment.
After completion of study treatment, patients are followed periodically for up to 2 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed metastatic spinal tumor
- •Localized spinal metastasis, defined as one of the following:
- •Solitary spinal metastasis
- •Two contiguous spinal levels
- •No more than 2 adjacent spinal levels involved by a single tumor
- •Involvement of ≤ 3 separate sites (e.g., C5, T5, and T12)
- •Tumor size ≤ 5 cm
- •PATIENT CHARACTERISTICS:
- •Karnofsky performance status 60-100%
- •Life expectancy ≥ 6 months
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •Must be ambulatory
排除标准
- •Not pregnant or nursing
- •No spinal instability
- •No rapid neurological decline
- •No bony retropulsions causing neurological abnormalities
- •No total paraplegia for > 48 hours
- •No psychological issues that would preclude completion of study treatment
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •No prior treatment for spinal tumor that would result in potential overlap of radiotherapy fields
- •No treatment that is expected to exceed spinal cord tolerance or other regional normal tissue tolerance
- •No tumors that are exquisitely radiosensitive and controlled with conventional radiotherapy (e.g., lymphoma, leukemia, multiple myeloma, or germ cell tumors)
研究组 & 干预措施
Single-fraction radiosurgery; 16 Gray
Subjects able to achieve the spinal cord dose constraints for single-fraction SRS stereotactic radiosurgery Radiation: stereotactic radiotherapy at 16 Gray Questionnaire administration diffusion tensor imaging functional magnetic resonance imaging
干预措施: questionnaire administration (Other)
Single-fraction radiosurgery; 16 Gray
Subjects able to achieve the spinal cord dose constraints for single-fraction SRS stereotactic radiosurgery Radiation: stereotactic radiotherapy at 16 Gray Questionnaire administration diffusion tensor imaging functional magnetic resonance imaging
干预措施: diffusion tensor imaging (Procedure)
Single-fraction radiosurgery; 16 Gray
Subjects able to achieve the spinal cord dose constraints for single-fraction SRS stereotactic radiosurgery Radiation: stereotactic radiotherapy at 16 Gray Questionnaire administration diffusion tensor imaging functional magnetic resonance imaging
干预措施: functional magnetic resonance imaging (Procedure)
Single-fraction radiosurgery; 16 Gray
Subjects able to achieve the spinal cord dose constraints for single-fraction SRS stereotactic radiosurgery Radiation: stereotactic radiotherapy at 16 Gray Questionnaire administration diffusion tensor imaging functional magnetic resonance imaging
干预措施: single-fraction SRS (Radiation)
Hypo-fractionated radiosurgery; 21 Gray
Subjects unable to achieve the spinal cord dose constraints for single-fraction radiosurgery (SRS), based on tumor location and expected tolerance dose to the adjacent normal tissue, will be offered hypo-fractionated SRS (3 fractions) Radiation: stereotactic radiotherapy Questionnaire administration diffusion tensor imaging functional magnetic resonance imaging hypo-fractionated radiation therapy at 21 Gray
干预措施: questionnaire administration (Other)
Hypo-fractionated radiosurgery; 21 Gray
Subjects unable to achieve the spinal cord dose constraints for single-fraction radiosurgery (SRS), based on tumor location and expected tolerance dose to the adjacent normal tissue, will be offered hypo-fractionated SRS (3 fractions) Radiation: stereotactic radiotherapy Questionnaire administration diffusion tensor imaging functional magnetic resonance imaging hypo-fractionated radiation therapy at 21 Gray
干预措施: diffusion tensor imaging (Procedure)
Hypo-fractionated radiosurgery; 21 Gray
Subjects unable to achieve the spinal cord dose constraints for single-fraction radiosurgery (SRS), based on tumor location and expected tolerance dose to the adjacent normal tissue, will be offered hypo-fractionated SRS (3 fractions) Radiation: stereotactic radiotherapy Questionnaire administration diffusion tensor imaging functional magnetic resonance imaging hypo-fractionated radiation therapy at 21 Gray
干预措施: functional magnetic resonance imaging (Procedure)
Hypo-fractionated radiosurgery; 21 Gray
Subjects unable to achieve the spinal cord dose constraints for single-fraction radiosurgery (SRS), based on tumor location and expected tolerance dose to the adjacent normal tissue, will be offered hypo-fractionated SRS (3 fractions) Radiation: stereotactic radiotherapy Questionnaire administration diffusion tensor imaging functional magnetic resonance imaging hypo-fractionated radiation therapy at 21 Gray
干预措施: hypo-fractionated SRS (Radiation)
Single-fraction radiosurgery; 18 Gray
Subjects able to achieve the spinal cord dose constraints for single-fraction SRS stereotactic radiosurgery Radiation: stereotactic radiotherapy at 18 Gray Questionnaire administration diffusion tensor imaging functional magnetic resonance imaging
干预措施: questionnaire administration (Other)
Single-fraction radiosurgery; 18 Gray
Subjects able to achieve the spinal cord dose constraints for single-fraction SRS stereotactic radiosurgery Radiation: stereotactic radiotherapy at 18 Gray Questionnaire administration diffusion tensor imaging functional magnetic resonance imaging
干预措施: diffusion tensor imaging (Procedure)
Single-fraction radiosurgery; 18 Gray
Subjects able to achieve the spinal cord dose constraints for single-fraction SRS stereotactic radiosurgery Radiation: stereotactic radiotherapy at 18 Gray Questionnaire administration diffusion tensor imaging functional magnetic resonance imaging
干预措施: functional magnetic resonance imaging (Procedure)
Single-fraction radiosurgery; 18 Gray
Subjects able to achieve the spinal cord dose constraints for single-fraction SRS stereotactic radiosurgery Radiation: stereotactic radiotherapy at 18 Gray Questionnaire administration diffusion tensor imaging functional magnetic resonance imaging
干预措施: single-fraction SRS (Radiation)
Single-fraction radiosurgery; 20 Gray
Subjects able to achieve the spinal cord dose constraints for single-fraction SRS stereotactic radiosurgery Radiation: stereotactic radiotherapy at 20 Gray Questionnaire administration diffusion tensor imaging functional magnetic resonance imaging
干预措施: questionnaire administration (Other)
Single-fraction radiosurgery; 20 Gray
Subjects able to achieve the spinal cord dose constraints for single-fraction SRS stereotactic radiosurgery Radiation: stereotactic radiotherapy at 20 Gray Questionnaire administration diffusion tensor imaging functional magnetic resonance imaging
干预措施: diffusion tensor imaging (Procedure)
Single-fraction radiosurgery; 20 Gray
Subjects able to achieve the spinal cord dose constraints for single-fraction SRS stereotactic radiosurgery Radiation: stereotactic radiotherapy at 20 Gray Questionnaire administration diffusion tensor imaging functional magnetic resonance imaging
干预措施: functional magnetic resonance imaging (Procedure)
Single-fraction radiosurgery; 20 Gray
Subjects able to achieve the spinal cord dose constraints for single-fraction SRS stereotactic radiosurgery Radiation: stereotactic radiotherapy at 20 Gray Questionnaire administration diffusion tensor imaging functional magnetic resonance imaging
干预措施: single-fraction SRS (Radiation)
Hypo-fractionated radiosurgery; 24 Gray
Subjects unable to achieve the spinal cord dose constraints for single-fraction radiosurgery (SRS), based on tumor location and expected tolerance dose to the adjacent normal tissue, will be offered hypo-fractionated SRS (3 fractions) Radiation: stereotactic radiotherapy Questionnaire administration diffusion tensor imaging functional magnetic resonance imaging hypo-fractionated radiation therapy at 24 Gray
干预措施: questionnaire administration (Other)
Hypo-fractionated radiosurgery; 24 Gray
Subjects unable to achieve the spinal cord dose constraints for single-fraction radiosurgery (SRS), based on tumor location and expected tolerance dose to the adjacent normal tissue, will be offered hypo-fractionated SRS (3 fractions) Radiation: stereotactic radiotherapy Questionnaire administration diffusion tensor imaging functional magnetic resonance imaging hypo-fractionated radiation therapy at 24 Gray
干预措施: diffusion tensor imaging (Procedure)
Hypo-fractionated radiosurgery; 24 Gray
Subjects unable to achieve the spinal cord dose constraints for single-fraction radiosurgery (SRS), based on tumor location and expected tolerance dose to the adjacent normal tissue, will be offered hypo-fractionated SRS (3 fractions) Radiation: stereotactic radiotherapy Questionnaire administration diffusion tensor imaging functional magnetic resonance imaging hypo-fractionated radiation therapy at 24 Gray
干预措施: functional magnetic resonance imaging (Procedure)
Hypo-fractionated radiosurgery; 24 Gray
Subjects unable to achieve the spinal cord dose constraints for single-fraction radiosurgery (SRS), based on tumor location and expected tolerance dose to the adjacent normal tissue, will be offered hypo-fractionated SRS (3 fractions) Radiation: stereotactic radiotherapy Questionnaire administration diffusion tensor imaging functional magnetic resonance imaging hypo-fractionated radiation therapy at 24 Gray
干预措施: hypo-fractionated SRS (Radiation)
Hypo-fractionated radiosurgery; 27 Gray
Subjects unable to achieve the spinal cord dose constraints for single-fraction radiosurgery (SRS), based on tumor location and expected tolerance dose to the adjacent normal tissue, will be offered hypo-fractionated SRS (3 fractions) Radiation: stereotactic radiotherapy Questionnaire administration diffusion tensor imaging functional magnetic resonance imaging hypo-fractionated radiation therapy at 27 Gray
干预措施: questionnaire administration (Other)
Hypo-fractionated radiosurgery; 27 Gray
Subjects unable to achieve the spinal cord dose constraints for single-fraction radiosurgery (SRS), based on tumor location and expected tolerance dose to the adjacent normal tissue, will be offered hypo-fractionated SRS (3 fractions) Radiation: stereotactic radiotherapy Questionnaire administration diffusion tensor imaging functional magnetic resonance imaging hypo-fractionated radiation therapy at 27 Gray
干预措施: diffusion tensor imaging (Procedure)
Hypo-fractionated radiosurgery; 27 Gray
Subjects unable to achieve the spinal cord dose constraints for single-fraction radiosurgery (SRS), based on tumor location and expected tolerance dose to the adjacent normal tissue, will be offered hypo-fractionated SRS (3 fractions) Radiation: stereotactic radiotherapy Questionnaire administration diffusion tensor imaging functional magnetic resonance imaging hypo-fractionated radiation therapy at 27 Gray
干预措施: functional magnetic resonance imaging (Procedure)
Hypo-fractionated radiosurgery; 27 Gray
Subjects unable to achieve the spinal cord dose constraints for single-fraction radiosurgery (SRS), based on tumor location and expected tolerance dose to the adjacent normal tissue, will be offered hypo-fractionated SRS (3 fractions) Radiation: stereotactic radiotherapy Questionnaire administration diffusion tensor imaging functional magnetic resonance imaging hypo-fractionated radiation therapy at 27 Gray
干预措施: hypo-fractionated SRS (Radiation)
结局指标
主要结局
Maximum tolerated dose - hypofraction
时间窗: 6 weeks
Maximum tolerated dose of CyberKnife® hypofractionated stereotactic radiosurgery
Maximum tolerated dose - single fraction
时间窗: 6 weeks
Maximum tolerated dose of CyberKnife® hypofractionated stereotactic radiosurgery
次要结局
- Spinal cord response(baseline and then at 6 weeks and 6 months after completion of treatment)
- Assessment of pain(baseline and then at 3, 6, 9, 12, 18, and 24 months after completion of treatment)
研究者
Minh Tam Truong
BMC Attending Physician
Boston Medical Center