A Phase I/II Dose Escalation Study Using Extracranial Stereotactic Radiosurgery to Control Pain
NCT ID: NCT00802659
Last Updated: 2014-12-05
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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TERMINATED
NA
2 participants
INTERVENTIONAL
2008-03-31
2008-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group -1
1000 cGY radiation
Stereotactic radiotherapy
This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment patient's pain, and how many side effects participants before you have experienced.
Group 1
1200 cGY radiation
Stereotactic radiotherapy
This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment patient's pain, and how many side effects participants before you have experienced.
Group 2
1400 cGY radiation
Stereotactic radiotherapy
This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment patient's pain, and how many side effects participants before you have experienced.
Group 3
1600 cGY radiation
Stereotactic radiotherapy
This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment patient's pain, and how many side effects participants before you have experienced.
Interventions
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Stereotactic radiotherapy
This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment patient's pain, and how many side effects participants before you have experienced.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Washington University School of Medicine
OTHER
Responsible Party
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Principal Investigators
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Jeffrey Bradley, M.D.
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Locations
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Washington University
St Louis, Missouri, United States
Countries
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Related Links
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(AlvinJ. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
Other Identifiers
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07-1149
Identifier Type: -
Identifier Source: org_study_id