NCT00508443Active, not recruitingPhase 1/2
Evaluation of a Novel CT-On-Rails or Trilogy Stereotactic Spine Radiotherapy System (SSRS)
Phase I/II Evaluation of a Novel CT-On-Rails or Trilogy Stereotactic Spine Radiotherapy System (SSRS) for the Treatment of Metastatic Spine Disease
Source: ClinicalTrials.gov · Last updated 2 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- First submitted
- 27 Jul 2007
- Start date
- 25 Oct 2002
- Primary completion date
- 31 Oct 2028
- Lead sponsor
- M.D. Anderson Cancer Center
- Diseases
- Melanoma, Lung cancer, Childhood cancers, Sarcoma
- NCT number
- NCT00508443
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 150
- From 25 Oct 2002 to the primary completion date, 31 Oct 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Unstable spine requiring surgical stabilization.
- Systemic radiotherapy (Sr-89) within 30 days
- Prior irradiation of the area to be treated within 3 months of registration
- Patients currently receiving, or who have received chemotherapy within 30 days are not eligible
- 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.
Other
- Sites outside the spine (eg. lung, liver) are not eligible for treatment
- Inability to tolerate lying flat on treatment couch for greater than 30 minutes.
- Patient with multiple myeloma
- Patients unable to undergo MRI of the spine
- Patients with pacemakers
Who the study is looking for
- 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.
Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Texas - MD Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.