Evaluation of a Novel CT-On-Rails or Trilogy Stereotactic Spine Radiotherapy System (SSRS) (NCT00508443) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
Evaluation of a Novel CT-On-Rails or Trilogy Stereotactic Spine Radiotherapy System (SSRS)
United States150 participantsStarted 2002-10-25
Plain-language summary
The goal of this clinical research study is to find out if stereotactic spine radiotherapy is safe and effective in the treatment of metastatic spine tumors. The feasibility of this type of treatment will be studied as will any side effects related to the treatment. The precision and accuracy of the CT-on-rails will also be studied.
Who can participate
SexALL
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Inclusion criteria
✓. Radiographically documented spine or paraspinal metastasis demonstrated on spine MRI within 4 wks of registration
✓. Maximum of 2 metastatic sites in the spine to be irradiated over a single course of treatment.
✓. Informed consent for irradiation or re-irradiation of spinal or para-spinal tumor (s)
✓. Diagnosis cancer including but not limited to lung (non-small cell and small cell), breast, prostate, renal cell, melanoma, gastrointestinal, germ cell tumors, and unknown primary tumors
✓. Karnofsky performance status of at least 40 (i.e. not requiring active hospitalization)
✓. Maximum of 1 prior course of spine radiotherapy to the current region of interest allowed.
Exclusion criteria
✕. Worsening neurological status due to radiographic evidence of spinal cord compression requiring immediate surgical decompression or emergent conventional external radiation therapy
✕. Delay in initiation of radiation treatment would be potentially detrimental to neurological outcome
✕. Patients already re-treated with radiation as part of this protocol will not be eligible for additional re-treatment