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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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25 March 2013 |
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Main ID: |
NCT00492817 |
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Date of registration:
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26/06/2007 |
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Primary sponsor: |
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Public title:
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Evaluation of Single Session Stereotactic Body Radiotherapy
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Scientific title:
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Phase I/II Evaluation of Single Session Stereotactic Body Radiotherapy for Spinal or Paraspinal Metastases |
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Date of first enrolment:
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October 2005 |
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Target sample size:
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60 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00492817 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Paul Brown, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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M.D. Anderson Cancer Center |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Radiographically documented spine or paraspinal metastasis demonstrated on spine MRI
within 4 weeks of registration
2. Maximum of 2 metastatic sites in the spine to be irradiated in single session
3. Informed consent for irradiation of spinal or para-spinal tumor (s)
4. Diagnosis of cancer including but not limited to lung (non-small cell and small
cell), breast, prostate, renal cell, melanoma, gastrointestinal, and germ cell
tumors, unknown primary tumors
5. Karnofsky performance status of at least 40 (ie not requiring active hospitalization)
Exclusion Criteria:
1. Worsening neurological status due to radiographic evidence of spinal cord compression
requiring immediate surgical decompression or emergent conventional external
radiation therapy.
2. Delay in initiation of radiation treatment would be potentially detrimental to
neurological outcome
3. Prior irradiation to current site of interest in the spine
4. Spinal metastasis in the cervical spine are not eligible for treatment
5. Unstable spine requiring surgical stabilization.
6. Sites outside the spine (eg. lung, liver) are not eligible for treatment
7. Patients currently receiving, or who have received chemotherapy within 30 days are
not eligible
8. Inability to tolerate lying flat on treatment couch for greater than 30 minutes.
9. Patient with multiple myeloma
10. Patients unable to undergo MRI of the spine
11. Patients with pacemakers
Age minimum:
N/A
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Spinal Neoplasms
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Intervention(s)
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Procedure: Stereotactic Body Radiotherapy
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Primary Outcome(s)
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Safety and effectiveness of stereotactic body radiotherapy to the spine using computerized tomography (CT)-on-Rails in the treatment of metastatic spine tumors.
[Time Frame: 5 Years]
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Secondary ID(s)
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2005-0445
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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