December 4, 2008 |
December 4, 2008 |
December 2007 |
To determine the optimal dose of stereotactic spinal irradiation needed to obtain durable pain control at 4 weeks in a previously irradiated spine field. [ Time Frame: 4 weeks after radiation,4 month first year, 6 months second year, and then annually for 2 additional years ] [ Designated as safety issue: Yes ] |
Same as current |
No Changes Posted |
- To determine the duration of pain control for each dose level. [ Time Frame: 4 weeks after radiation,4 month first year, 6 months second year, and then annually for 2 additional years ] [ Designated as safety issue: Yes ]
- Determine the rate of radiation-induced myelopathy from stereotactic re-irradiation of the spinal metastases. [ Time Frame: 4 weeks after radiation,4 month first year, 6 months second year, and then annually for 2 additional years ] [ Designated as safety issue: Yes ]
- Determine the pattern of failure after stereotactic irradiation of spinal metastases. [ Time Frame: 4 weeks after radiation,4 month first year, 6 months second year, and then annually for 2 additional years ] [ Designated as safety issue: Yes ]
- Measure quality of life in patients treated with stereotactic radiotherapy (ESRT) [ Time Frame: 4 weeks after radiation,4 month first year, 6 months second year, and then annually for 2 additional years ] [ Designated as safety issue: Yes ]
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Same as current |
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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. |
Phase I, Phase II |
Interventional |
Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Metastases |
Radiation: Stereotactic radiotherapy |
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|
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Recruiting |
100 |
December 2013 |
December 2011 (final data collection date for primary outcome measure) |
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
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Both |
18 Years and older |
No |
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United States |
|
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NCT00802659 |
Jeffrey Bradley, M.D., Washington University |
07-1149 |
Washington University School of Medicine |
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Principal Investigator: |
Jeffrey Bradley, M.D. |
Washington University School of Medicine |
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Washington University School of Medicine |
December 2008 |