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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
5
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.
The Sidney Kimmel Comprehsensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
Change in Intensity of Bone Pain
To estimate the rate of clinically meaningful decrease in diffuse osseous pain following radiosurgical hypophysectomy at 4 weeks following completion of radiosurgical hypophysectomy
Time frame: 4 weeks
Rate of change of disease spread
To estimate the rate of clinically meaningful decrease in diffuse osseous pain following radiosurgical hypophysectomy
Time frame: Up to 100 weeks following completion of radiosurgical hypophysectomy
Rate of Change of Quality of Life
To estimate the rate of clinically meaningful increase in patient reported quality of life following radiosurgical hypophysectomy
Time frame: Up to 100 weeks following completion of radiosurgical hypophysectomy
Rate of change in opioid use
To estimate the rate of reduction in opioid utilization following radiosurgical hypophysectomy
Time frame: Up to 100 weeks following completion of radiosurgical hypophysectomy
Rate of biochemical endocrinopathy
To estimate the rate of biochemical endocrinopathy following radiosurgical hypophysectomy
Time frame: Up to 100 weeks following completion of radiosurgical hypophysectomy
Rate of change of optic nueropathy
To estimate the risk of radiation induced optic neuropathy following radiosurgical hypophysectomy
Time frame: Up to 100 weeks following completion of radiosurgical hypophysectomy
Rate of change of neurologic toxicity
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To estimate the radiation-associated acute and long term neurologic toxicity of radiosurgical hypophysectomy
Time frame: Up to 100 weeks following completion of radiosurgical hypophysectomy
Rate of change of insipidus diabetes
To estimate the rate of diabetes insipidus following radiosurgical hypophysectomy
Time frame: Up to 100 weeks following completion of radiosurgical hypophysectomy
Rate of change in costs
To estimate the cost effectiveness of radiosurgical hypophysectomy
Time frame: Up to 100 weeks following completion of radiosurgical hypophysectomy
Rate of change of cortisol
To estimate the relationship between pain response and cortisol levels
Time frame: Up to 100 weeks following completion of radiosurgical hypophysectomy
Rate of change of pain with respect to hormones
To estimate the rate of pain response in hormonally active and non-hormonally active tumors
Time frame: Up to 100 weeks following completion of radiosurgical hypophysectomy
Rate of change of pain with respect to morphine
To estimate the rate of pain response in morphine sensitive and morphine insensitive tumors
Time frame: Up to 100 weeks following completion of radiosurgical hypophysectomy