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

Stopped early · Not applicable

Conditions studied: Metastases

In brief

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.

Key facts

Study ID

NCT00802659

Run by

Washington University School of Medicine

People needed

2

Starts

2008-03-01

Expected to finish

2008-12-01

Last updated by the study team

2014-12-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Washington University — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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