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. 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.
Time frame: Post treatment day 10
Participants With Reduction in Opioid Utilization Following Radiosurgical Hypophysectomy
To estimate the rate of reduction in opioid utilization following radiosurgical hypophysectomy
Time frame: Approximately 28 weeks following completion of radiosurgical hypophysectomy
Participants With Radiation Induced Optic Neuropathy Following Radiosurgical Hypophysectomy
To estimate the risk of radiation induced optic neuropathy following radiosurgical hypophysectomy
Time frame: Approximately 28 weeks following completion of radiosurgical hypophysectomy
Participants With Radiation-associated Acute and Long Term Neurologic Toxicity
To estimate the radiation-associated acute and long term neurologic toxicity of radiosurgical hypophysectomy
Time frame: Approximately 28 weeks following completion of radiosurgical hypophysectomy
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