Bone Metastases
Conditions
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.
Interventions
RADIATIONradiosurgical hypophysectomy
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.
Sponsors
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Accuray Incorporated
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Intensity of Bone Pain | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participants With Reduction in Opioid Utilization Following Radiosurgical Hypophysectomy | Approximately 28 weeks following completion of radiosurgical hypophysectomy | To estimate the rate of reduction in opioid utilization following radiosurgical hypophysectomy |
| Participants With Radiation Induced Optic Neuropathy Following Radiosurgical Hypophysectomy | Approximately 28 weeks following completion of radiosurgical hypophysectomy | To estimate the risk of radiation induced optic neuropathy following radiosurgical hypophysectomy |
| Participants With Radiation-associated Acute and Long Term Neurologic Toxicity | Approximately 28 weeks following completion of radiosurgical hypophysectomy | To estimate the radiation-associated acute and long term neurologic toxicity of radiosurgical hypophysectomy |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORKristin Redmond, MD
Johns Hopkins University
Participant flow
Pre-assignment details
5 participants consented. 2 participants withdrew before assignment to the study arm (too ill; decided not to proceed). 3 participants were assigned to the study arm.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Customized 40 - 49 years | 1 Participants |
| Age, Customized 50 - 59 years | 2 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 3 / 3 |
| other Total, other adverse events | 0 / 3 |
| serious Total, serious adverse events | 0 / 3 |
Outcome results
None listed