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Sponsored by: |
Washington University School of Medicine |
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Information provided by: | Washington University School of Medicine |
ClinicalTrials.gov Identifier: | NCT00802659 |
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.
Condition | Intervention | Phase |
---|---|---|
Metastases |
Radiation: Stereotactic radiotherapy |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | 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 |
Estimated Enrollment: | 100 |
Study Start Date: | December 2007 |
Estimated Study Completion Date: | December 2013 |
Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
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 Radiation Dose 1000 cGy Group 2 Radiation Dose 1200 cGy Group 3 Radiation Dose 1400 cGy Group 4 Radiation Dose 1600 cGY |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jeffrey Bradley, M.D. | 314-362-8525 | bradley@radonc.wustl.edu |
United States, Missouri | |
Washington University | Recruiting |
St. Louis, Missouri, United States, 63110 | |
Contact: Judy Johson 314-362-6045 johnsonj@ccadmin.wustl.edu | |
Principal Investigator: Jeffrey Bradley, M.D. |
Principal Investigator: | Jeffrey Bradley, M.D. | Washington University School of Medicine |
Responsible Party: | Washington University ( Jeffrey Bradley, M.D. ) |
Study ID Numbers: | 07-1149 |
Study First Received: | December 4, 2008 |
Last Updated: | December 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00802659 History of Changes |
Health Authority: | United States: Institutional Review Board |
Neoplasm Metastasis Pain |
Neoplasms Neoplastic Processes Pathologic Processes Neoplasm Metastasis |