Spinal NeoplasmsPhase 1/2NCT00492817
Evaluation of Single Session Stereotactic Body Radiotherapy
A Phase 1/2 study testing Stereotactic Body Radiotherapy in people with Spinal Neoplasms, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Spinal Neoplasms
- What is being tested?
- Stereotactic Body Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Oct 2005to 27 Nov 2024
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
- Spinal metastasis in the cervical spine are not eligible for treatment
- Unstable spine requiring surgical stabilization.
- Sites outside the spine (eg. lung, liver) are not eligible for treatment
Show all 11Show fewer
- Patients currently receiving, or who have received chemotherapy within 30 days are not eligible
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Phase I/II Evaluation of Single Session Stereotactic Body Radiotherapy for Spinal or Paraspinal Metastases
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.
Read the detailed description
CT-on-Rails is a system that places the radiation treatment machine in the same room as the CT scanner so that the CT scanner can help deliver radiation more precisely.
You will have a MRI of the spine within 1 month before registration on this study. You will also fill out a health survey, a symptom inventory, and a Brief Pain Inventory within 1 week before registration. Each of these surveys should take about 5 minutes to complete. You will have a CT-simulation. The simulation is like a CT scan where a special body frame is used to keep you from moving during scanning and later radiation treatment. However, no radiation is delivered during the simulation. You will be asked questions about your medical history and have a complete neurological exam during your first consultation, before registration. The neurological exam involves testing upper and lower motor strength, sensation to light touch, reflexes, a mental exam, and an evaluation of the way you walk.
Radiation treatment will last between 2 and 2 1/2 hours and will be given on 1 day about 1 to 1 1/2 weeks after you had the simulation. You will have a device (similar to plastic wrap) placed around you that will hold you still during the treatment. You will be checked for level of pain and/or discomfort before starting each session of radiation, and you may take pain medications before starting each session. All participants will be treated with radiation therapy that is guided by the CT-on-Rails procedure. On the day of radiation, you will also receive a CT scan using CT-on-Rails in the same treatment room, immediately before the radiation treatment.
During treatment, a physician will be monitoring you for any side effects. If you experience severe side effects, radiation treatment will be stopped, and you will be taken off study. After treatment on this study ends, you will have telephone, mail, or facsimile (Fax) follow-ups scheduled at 1, 2, 3, 4, and 8 weeks after radiation. You will be asked questions about any side effects or pain you are experiencing and any other therapies you may have started.
You will have follow-up visits scheduled at 3, 6, 9, 12, 18, and 24 months and then every 6 months for the rest of your life. At all follow-up visits, you will be asked questions about your medical history, have a neurological exam, and your neurologic function will be evaluated. Any pain medication you are taking will be noted. You will be asked to have a MRI of the spine at 3, 6, 9, 12,18, and 24 months, then once a year for the rest of your life. You will also be asked to complete 3 questionnaires to evaluate your symptoms, pain, and quality of life at each follow-up visit. Each questionnaire should take around 5 minutes to complete.
This is an investigational study. The equipment used in this study are FDA-approved medical devices and are commercially available. However, the way the devices are being used in this study is experimental. Up to 60 patients will take part in this study. All will be enrolled at M. D. Anderson.
- Conditions
- Spinal Neoplasms
- Being tested
- Stereotactic Body Radiotherapy
- Keywords
- Spinal Neoplasms, Paraspinal Metastases, Stereotactic Body Radiotherapy, CT-on-Rails, Spinal Cord, SBRT
- Medical subject headings
- Spinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic Body RadiotherapyProcedure or surgery
Also called SBRT
On day 1 of radiation treatment, a CT scan using CT-on-Rails in the same treatment room, immediately before the radiation treatment will be performed.
| Study group | Role | What they receive |
|---|---|---|
| Single Session Stereotactic Body Radiotherapy (SBRT) | Experimental | On day 1 of radiation treatment, a CT scan using CT-on-Rails in the same treatment room, immediately before the radiation treatment will be performed. Receives: Procedure: Stereotactic Body Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Pain Relief Using Stereotactic Body Radiotherapy (SBRT) to Treat Spine and Para- Spinal Tumors in a Single Session
To measure 6-month complete pain relief, i.e., 6-month "pain worst" from the BPI being zero
Measured: Six months after completion of radiation therapy
Local Tumor Control Rate
Local tumor control rate as measured based on spinal MRI showing absence of progression
Measured: local tumor control rate, the time frame is up to 48 months
Paralysis (Grade 4 Motor Neuropathy)
Evidence of paralysis (Grade 4 motor neuropathy) casued by radiation myelitis
Measured: Up to 24 months after radiation therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2007 (estimated)
- Study start13 Oct 2005
- Primary completion27 Nov 2024
- Study completion27 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Spinal NeoplasmsStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amol J. Ghia, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00492817
- Sponsor's protocol ID
- 2005-0445
- Other IDs
- NCI-2012-01499
- Status last verified
- Oct 2025
- First submitted
- 26 Jun 2007
- Last updated
- 24 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Evaluation of Single Session Stereotactic Body Radiotherapy for Spinal or Paraspinal Metastases
- ClinicalTrials.gov ID
- NCT00492817
- Acronym / sponsor ID
- 2005-0445
- Conditions
- Spinal Neoplasms
- Keywords
- Spinal Neoplasms, Paraspinal Metastases, Stereotactic Body Radiotherapy, CT-on-Rails, Spinal Cord, SBRT
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 13 Oct 2005 (actual)
- Primary completion
- 27 Nov 2024 (actual)
- Study completion
- 27 Nov 2024 (actual)
- First posted
- 27 Jun 2007 (estimated)
- Results
- Posted 24 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
CT-on-Rails is a system that places the radiation treatment machine in the same room as the CT scanner so that the CT scanner can help deliver radiation more precisely.
You will have a MRI of the spine within 1 month before registration on this study. You will also fill out a health survey, a symptom inventory, and a Brief Pain Inventory within 1 week before registration. Each of these surveys should take about 5 minutes to complete. You will have a CT-simulation. The simulation is like a CT scan where a special body frame is used to keep you from moving during scanning and later radiation treatment. However, no radiation is delivered during the simulation. You will be asked questions about your medical history and have a complete neurological exam during your first consultation, before registration. The neurological exam involves testing upper and lower motor strength, sensation to light touch, reflexes, a mental exam, and an evaluation of the way you walk.
Radiation treatment will last between 2 and 2 1/2 hours and will be given on 1 day about 1 to 1 1/2 weeks after you had the simulation. You will have a device (similar to plastic wrap) placed around you that will hold you still during the treatment. You will be checked for level of pain and/or discomfort before starting each session of radiation, and you may take pain medications before starting each session. All participants will be treated with radiation therapy that is guided by the CT-on-Rails procedure. On the day of radiation, you will also receive a CT scan using CT-on-Rails in the same treatment room, immediately before the radiation treatment.
During treatment, a physician will be monitoring you for any side effects. If you experience severe side effects, radiation treatment will be stopped, and you will be taken off study. After treatment on this study ends, you will have telephone, mail, or facsimile (Fax) follow-ups scheduled at 1, 2, 3, 4, and 8 weeks after radiation. You will be asked questions about any side effects or pain you are experiencing and any other therapies you may have started.
You will have follow-up visits scheduled at 3, 6, 9, 12, 18, and 24 months and then every 6 months for the rest of your life. At all follow-up visits, you will be asked questions about your medical history, have a neurological exam, and your neurologic function will be evaluated. Any pain medication you are taking will be noted. You will be asked to have a MRI of the spine at 3, 6, 9, 12,18, and 24 months, then once a year for the rest of your life. You will also be asked to complete 3 questionnaires to evaluate your symptoms, pain, and quality of life at each follow-up visit. Each questionnaire should take around 5 minutes to complete.
This is an investigational study. The equipment used in this study are FDA-approved medical devices and are commercially available. However, the way the devices are being used in this study is experimental. Up to 60 patients will take part in this study. All will be enrolled at M. D. Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Session Stereotactic Body Radiotherapy (SBRT) | Experimental | Procedure: Stereotactic Body RadiotherapyOn day 1 of radiation treatment, a CT scan using CT-on-Rails in the same treatment room, immediately before the radiation treatment will be performed. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (11 listed)
- 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
- Spinal metastasis in the cervical spine are not eligible for treatment
- Unstable spine requiring surgical stabilization.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stereotactic Body RadiotherapyAlso: SBRTOn day 1 of radiation treatment, a CT scan using CT-on-Rails in the same treatment room, immediately before the radiation treatment will be performed. | Procedure or surgery | Single Session Stereotactic Body Radiotherapy (SBRT) |
Primary outcome
Complete Pain Relief Using Stereotactic Body Radiotherapy (SBRT) to Treat Spine and Para- Spinal Tumors in a Single Session
Time frame: Six months after completion of radiation therapy
To measure 6-month complete pain relief, i.e., 6-month "pain worst" from the BPI being zero
Local Tumor Control Rate
Time frame: local tumor control rate, the time frame is up to 48 months
Local tumor control rate as measured based on spinal MRI showing absence of progression
Paralysis (Grade 4 Motor Neuropathy)
Time frame: Up to 24 months after radiation therapy
Evidence of paralysis (Grade 4 motor neuropathy) casued by radiation myelitis
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- M D Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amol J. Ghia, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Stereotactic Body Radiotherapy in people with Spinal Neoplasms, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Pain Relief Using Stereotactic Body Radiotherapy (SBRT) to Treat Spine and Para- Spinal Tumors in a Single Session (time frame: Six months after completion of radiation therapy). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2025.