NCT00492817CompletedPhase 1/2
Evaluation of Single Session Stereotactic Body Radiotherapy
Phase I/II Evaluation of Single Session Stereotactic Body Radiotherapy for Spinal or Paraspinal Metastases
Source: ClinicalTrials.gov · Last updated 24 Oct 2025
Brief summary (registry, in English)
The goal of this clinical research study is to find out if stereotactic body radiotherapy to the spine using computerized tomography (CT)-on-Rails is safe and effective in the treatment of metastatic spine tumors. Objectives: * Establish the safety and efficacy of using stereotactic body radiotherapy (SBRT) to treat spine and para-spinal tumors in a single session. * Document frequency and severity of pain, symptoms and symptom interference, as well as quality of life before and after treatment. * Document changes in neurological function at defined intervals compared to pre-treatment neurological function.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 71 (actual)
- First submitted
- 26 Jun 2007
- Start date
- 13 Oct 2005
- Primary completion date
- 27 Nov 2024
- Lead sponsor
- M.D. Anderson Cancer Center
- Diseases
- Childhood cancers
- NCT number
- NCT00492817
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 71
- From 13 Oct 2005 to the primary completion date, 27 Nov 2024
- 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
- Prior irradiation to current site of interest in the spine
- Unstable spine requiring surgical stabilization.
- Patients currently receiving, or who have received chemotherapy within 30 days are not eligible
Other
- Spinal metastasis in the cervical spine are not eligible for treatment
- 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 weeks of registration
- Maximum of 2 metastatic sites in the spine to be irradiated in single session
- Informed consent for irradiation of spinal or para-spinal tumor (s)
- 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
- Karnofsky performance status of at least 40 (ie not requiring active hospitalization)
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.