Clinical trial NCT03377517: Radiosurgical Hypophysectomy for Bone Metasteses Pain
Official title: A Pilot Study of Stereotactic Radiosurgical Hypophysectomy for Intractable Pain From Bone Metastases
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bone Metastases
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sponsor class: OTHER
Collaborators: name: Accuray Incorporated
First posted: 2017-12-19
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Cytologic proof of malignancy
2. Radiographic evidence of bone metastases
3. 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 4.
4. 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
5. Life expectancy at least 4 weeks
6. Age≥ 18 years
7. Patients of childbearing potential (male or female) must practice adequate contraception due to possible harmful effects of radiation therapy on an unborn child
8. Patient must have the ability to understand and the willingness to sign a written informed consent document
9. 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

Exclusion Criteria:

1. Prior brain radiation
2. 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
3. Isolated localized pain amenable to focal radiation therapy, or pain well controlled by opioids, medical management, injections/ablation or surgical intervention
4. Malignancies being managed with curative intent
5. Life expectancy \<4 weeks
6. The tumor amenable to curative management

Primary outcomes:
measure: Change in Intensity of Bone Pain
timeFrame: 4 weeks
Secondary outcomes:
measure: Rate of change of disease spread
timeFrame: Up to 100 weeks following completion of radiosurgical hypophysectomy
measure: Rate of Change of Quality of Life
timeFrame: Up to 100 weeks following completion of radiosurgical hypophysectomy
measure: Rate of change in opioid use
timeFrame: Up to 100 weeks following completion of radiosurgical hypophysectomy
measure: Rate of biochemical endocrinopathy
timeFrame: Up to 100 weeks following completion of radiosurgical hypophysectomy
measure: Rate of change of optic nueropathy
timeFrame: Up to 100 weeks following completion of radiosurgical hypophysectomy
measure: Rate of change of neurologic toxicity
timeFrame: Up to 100 weeks following completion of radiosurgical hypophysectomy
measure: Rate of change of insipidus diabetes
timeFrame: Up to 100 weeks following completion of radiosurgical hypophysectomy
measure: Rate of change in costs
timeFrame: Up to 100 weeks following completion of radiosurgical hypophysectomy
measure: Rate of change of cortisol
timeFrame: Up to 100 weeks following completion of radiosurgical hypophysectomy
measure: Rate of change of pain with respect to hormones
timeFrame: Up to 100 weeks following completion of radiosurgical hypophysectomy
measure: Rate of change of pain with respect to morphine
timeFrame: Up to 100 weeks following completion of radiosurgical hypophysectomy
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: The Sidney Kimmel Comprehsensive Cancer Center at Johns Hopkins
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Kristin Redmond, MD
role: PRINCIPAL_INVESTIGATOR
References: