A Phase I/II Dose Escalation Study Using Extracranial Stereotactic Radiosurgery to Control Pain

A Phase I/II Dose Escalation Study to Evaluate Pain Response Using Extracranial Stereotactic Radiosurgery to Treat Paraspinal Metastasis in Patients Who Have Received Prior Spinal Irradiation

This study will evaluate pain control and quality of life in patients with paraspinal metastases, who have receive previous radiation therapy to these lesions, using single dose stereotactic radiotherapy.

The goal of the study is to determine the lowest dose of radiation that can be given to effectively control the tumor and provide effective pain relief.

Inclusion Criteria:

• Age ≥ 18
• Prior non-hematogenous, histologically proven malignancy (specific exclusions are multiple myeloma and lymphoma)
• Pain attributable to one or two radiographically apparent metastatic lesion(s) amenable to ESRT
• Have had prior radiation to area of spine felt to be cause of patient's pain
• Zubrod performance status of 0-3
• Life expectancy of ≥ 3 months
• Signed informed consent prior to registration to study
• Radiographic evidence of stable disease outside of the spinal column for at least 6 weeks prior to study entry, as evaluated by pre-study imaging.

Exclusion Criteria:

• Women who are pregnant or nursing
• Either 'no evidence of other active cancerous disease' or 'other sites of known disease are locally controlled'
• No radiographic evidence of spinal instability (e.g. spinal cord compression requiring immediate surgical intervention)
• No initiation of chemotherapy within 15 days of trial entry.
• No plans for concomitant antineoplastic therapy (including standard fractionated RT, chemotherapy, biologic, vaccine therapy, or surgery) for at least 15 days following stereotactic radiosurgery.
• No active systemic infection.
• No evidence of myelopathy or cauda equina syndrome on clinical evaluation