Active Not RecruitingPhase 1 / Phase 2NCT00508443

Evaluation of a Novel CT-On-Rails or Trilogy Stereotactic Spine Radiotherapy System (SSRS)

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.

Checked against the public recordLast updated Jul 17, 2026 · Source: ClinicalTrials.gov

StatusActive Not Recruiting
PhasePhase 1 / Phase 2
U.S. locations1
SponsorM.D. Anderson Cancer Center
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Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1 / Phase 2
Sponsor
M.D. Anderson Cancer Center
Interventions being studied
Radiation: Radiation Therapy
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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Treatment approach
03
Public criteria

Who may be able to participate

Inclusion Criteria: 1. Radiographically documented spine or paraspinal metastasis demonstrated on spine MRI within 4 wks of registration 2. Maximum of 2 metastatic sites in the spine to be irradiated over a single course of treatment. 3. Informed consent for irradiation or re-irradiation of spinal or para-spinal tumor (s) 4. 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 5. Karnofsky performance status of at least 40 (i.e. not requiring active hospitalization) 6. Maximum of 1 prior course of spine radiotherapy to the current region of interest allowed. 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. Patients already re-treated with radiation as part of this protocol will not be eligible for additional re-treatment 4. Unstable spine requiring surgical stabilization. 5. Sites outside the spine (eg. lung, liver) are not eligible for treatment 6. Systemic radiotherapy (Sr-89) within 30 days 7. Prior irradiation of the area to be treated within 3 months of registration 8. Patients currently receiving, or who have received chemotherapy within 30 days are not eligible 9. Inability to tolerate lying flat on treatment couch for greater than 30 minutes. 10. Patient with multiple myeloma 11. Patients unable to undergo MRI of the spine 12. Patients with pacemakers 13. Patients who have previously received maximum cord tolerance of 45 Gy in 5 weeks conventional fractionation or equivalent dose to the current area to be treated.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

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Study sites

U.S. locations

  • University of Texas MD Anderson Cancer CenterHouston, Texas

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 17, 2026. Always confirm current availability with the study team.

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