Stereotactic Radiosurgery in Reducing Pain in Cancer Patients with Bone Metastases

Inclusion Criteria

• Histologic proof or unequivocal cytologic proof of malignancy. This may be obtained from either the primary or any metastatic site
• Radiographic evidence of bone metastases on plain x-ray, CT, MRI, and/or bone scan
• 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 in spite of maximum tolerated doses of opioids and other medications
• Definitive radiographic progression of osseous and/or visceral metastases on standard staging scans (CT, MRI, bone scan, positron emission tomography [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
• Delivery of palliative chemotherapy or other systemic is permitted. However, no curative chemotherapy regimens are allowed and patients may not start a new systemic therapy within 4 weeks following completion of stereotactic radiosurgery (SRS)
• Life expectancy at least 4 weeks
• Patients of childbearing potential (male or female) must practice adequate contraception due to possible harmful effects of radiation therapy on an unborn child
• Patient must have the ability to understand and the willingness to sign a written informed consent document
• 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

• Maximum cumulative BED3 to the optic apparatus including prior treatments and the current study treatment of > 130 Gy
• 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
• Isolated localized pain amenable to focal radiation therapy, or pain well controlled by opioids, medical management, injections/ablation or surgical intervention
• Malignancies being managed with curative intent
• Life expectancy < 4 weeks
• The tumor amenable to curative management
• Chemotherapy delivery with curative intent
• No new systemic therapies may be started within the first 4 weeks of the experimental SRS treatment