A Pilot Study of Stereotactic Radiosurgical Hypophysectomy for Intractable Pain From Bone Metastases
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 3
- 主要终点
- Change in Intensity of Bone Pain
研究概览
简要总结
This research is being done to see if a delivery of a single high dose of radiation therapy to a small area of the pituitary gland and pituitary stalk in a highly precise manner may be helpful in reducing intractable pain from bone metastases.
详细描述
Although not currently standard of care, small series suggest both safety and efficacy of radiosurgical hypophysectomy in reducing cancer pain from bone metastases. In spite of the demonstrated feasibility in meeting normal tissue constraints and preliminary data suggestive of both safety and efficacy, radiosurgical hypophysectomy is rarely performed in clinical practice, and many radiation oncologists are not even aware of its potential to reduce intractable cancer pain. This is likely because, to date, well-designed prospective studies have not been performed to further explore both the safety and efficacy of the intervention. This single arm pilot study is designed to fill that void. If successful, the investigators plan to utilize the data to support the proposal of a larger scale follow-up clinical trial.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cytologic proof of malignancy
- •Radiographic evidence of bone metastases
- •Intractable pain uncontrolled by opioids, medical management, injections/ablation or surgical intervention that would be difficult to address with conventional radiation therapy or other standard options and is limiting the patient's function and quality of life. Intractable pain will be defined as a visual analogue score of at least
- •Definitive radiographic progression of osseous and/or visceral metastases on standard staging scans (CT, MRI, bone scan, PET scan or any other standard of care imaging) performed within the last 3 months in spite of standard oncologic interventions and/or inability to tolerate standard oncologic interventions
- •Life expectancy at least 4 weeks
- •Age≥ 18 years
- •Patients of childbearing potential (male or female) must practice adequate contraception due to possible harmful effects of radiation therapy on an unborn child
- •Patient must have the ability to understand and the willingness to sign a written informed consent document
- •All patients must be informed of the investigational nature of this study and must be given written informed consent in accordance with institutional and federal guidelines
排除标准
- •Prior brain radiation
- •Patients must not have a serious medical or psychiatric illness that would, in the opinion of the treating physician prevent informed consent or completion of protocol treatment
- •Isolated localized pain amenable to focal radiation therapy, or pain well controlled by opioids, medical management, injections/ablation or surgical intervention
- •Malignancies being managed with curative intent
- •Life expectancy <4 weeks
- •The tumor amenable to curative management
研究组 & 干预措施
Research Treatment Plan for all study enrollees
Patients will be treated to a dose of 150 Gy in a single fraction. All patients will undergo CT simulation with 1 mm slices as well as MRI simulation including at least high resolution 1 mm slice T1 weighted MRI. They will be treated in a supine position using an aquaplast mask system for immobilization.
干预措施: radiosurgical hypophysectomy (Radiation)
结局指标
主要结局
Change in Intensity of Bone Pain
时间窗: 4 weeks
To estimate the rate of clinically meaningful decrease in diffuse osseous pain following radiosurgical hypophysectomy at 4 weeks following completion of radiosurgical hypophysectomy
Change in Intensity of Bone Pain
时间窗: Post treatment day 10
To estimate the rate of clinically meaningful decrease in diffuse osseous pain following radiosurgical hypophysectomy at 4 weeks following completion of radiosurgical hypophysectomy. Score range 0-10, higher score worse pain. A 2 point reduction in the worst pain severity score on the Brief Pain Index (ie: question number 3) at 4 weeks following completion of radiosurgical hypophysectomy compared to baseline will be considered as clinically meaningful decrease.
次要结局
- Rate of change of disease spread(Up to 100 weeks following completion of radiosurgical hypophysectomy)
- Rate of Change of Quality of Life(Up to 100 weeks following completion of radiosurgical hypophysectomy)
- Rate of change in opioid use(Up to 100 weeks following completion of radiosurgical hypophysectomy)
- Rate of biochemical endocrinopathy(Up to 100 weeks following completion of radiosurgical hypophysectomy)
- Rate of change of optic nueropathy(Up to 100 weeks following completion of radiosurgical hypophysectomy)
- Rate of change of neurologic toxicity(Up to 100 weeks following completion of radiosurgical hypophysectomy)
- Rate of change of insipidus diabetes(Up to 100 weeks following completion of radiosurgical hypophysectomy)
- Rate of change in costs(Up to 100 weeks following completion of radiosurgical hypophysectomy)
- Rate of change of cortisol(Up to 100 weeks following completion of radiosurgical hypophysectomy)
- Rate of change of pain with respect to hormones(Up to 100 weeks following completion of radiosurgical hypophysectomy)
- Rate of change of pain with respect to morphine(Up to 100 weeks following completion of radiosurgical hypophysectomy)
- Participants With Reduction in Opioid Utilization Following Radiosurgical Hypophysectomy(Approximately 28 weeks following completion of radiosurgical hypophysectomy)
- Participants With Radiation Induced Optic Neuropathy Following Radiosurgical Hypophysectomy(Approximately 28 weeks following completion of radiosurgical hypophysectomy)
- Participants With Radiation-associated Acute and Long Term Neurologic Toxicity(Approximately 28 weeks following completion of radiosurgical hypophysectomy)