Status:
TERMINATED
A Phase I/II Dose Escalation Study Using Extracranial Stereotactic Radiosurgery to Control Pain
Lead Sponsor:
Washington University School of Medicine
Conditions:
Metastases
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 radiother...
Detailed Description
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT00802659
Start Date
March 1 2008
End Date
December 1 2008
Last Update
December 5 2014
Active Locations (1)
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1
Washington University
St Louis, Missouri, United States, 63110