Radiosurgical Hypophysectomy for Bone Metasteses Pain

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.

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