Spinal NeoplasmsPhase 1/2NCT00508443
Evaluation of a Novel CT-On-Rails or Trilogy Stereotactic Spine Radiotherapy System (SSRS)
A Phase 1/2 study testing Radiation Therapy 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 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Spinal Neoplasms
- What is being tested?
- Radiation Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Oct 2002to 31 Oct 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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 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.
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
- Patients already re-treated with radiation as part of this protocol will not be eligible for additional re-treatment
- Unstable spine requiring surgical stabilization.
- Sites outside the spine (eg. lung, liver) are not eligible for treatment
- Systemic radiotherapy (Sr-89) within 30 days
Show all 13Show fewer
- 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
- 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
- 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.
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 a Novel CT-On-Rails or Trilogy Stereotactic Spine Radiotherapy System (SSRS) for the Treatment of Metastatic Spine Disease
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.
Read the detailed description
CT-On-Rails or Trilogy 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 of registration on this study. You will also fill out a health survey (5 minutes), a symptom inventory ( 5 minutes), and a Brief Pain Inventory (5 minutes) within 1 week of registration.
A pretreatment feasibility study will first be performed to determine the precision, accuracy, and reproducibility with which the target volume and critical normal structures (e.g. spinal cord) can be positioned relative to the radiation beams for spine tumors; this will consist of a CT scan.
Patients will have a CT-simulation. The simulation is like a CT scan where a special body frame is used to keep the patient from moving during scanning and later treatment.
You will be asked questions about your medical history and have a complete neurological exam during your first consultation. The neurological exam involves testing upper and lower motor strength, sensation to light touch, reflexes, mental exam, and way you walk. MRI of the spine must be performed within 1 month of registration. You will be asked to complete 3 questionnaires to evaluate your symptoms and pain. Each questionnaire will take around 5 minutes to complete, and should be completed within 1 month of being enrolled in the study.
All patients will be treated with radiation therapy that is guided by the CT-on-Rails or Trilogy procedure. Patients will receive a CT scan immediately before the treatment in the same room of the treatment using CT-On-Rails or Trilogy. There will be a total of 3 treatments over a period of 2 weeks.
Monitoring of side effects will be focused on neurological, gastrointestinal, musculoskeletal, and hematological systems. Every attempt will be made to have the patient complete the prescribed course of radiation to maximize the beneficial effect of treatment. However, if there is severe side effects, radiation treatment will be stopped and patients will be taken off study.
You will have follow up visits once a week during radiation treatment, scheduled on the same day as radiation. After treatment, you will have telephone, mail, or follow-ups per fax scheduled at 2 and 4 weeks,and 2 months post radiation. You will have follow up visits scheduled at 3, 6, 9, 12, 18, and 24 months, then every six 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 neurologic function will be evaluated. Any pain medication you are taking will be noted. You will have an 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 and pain. Each questionnaire will take around 5 minutes to complete.
This is an investigational study. The CT-on-rails and Trilogy linear accelerator are FDA-approved medical devices and are commercially available, however, the way these two devices are being used is investigational. Up to 150 patients will take part in this study. All will be enrolled at M. D. Anderson.
- Conditions
- Spinal Neoplasms
- Being tested
- Radiation Therapy
- Keywords
- Stereotactic Spine Radiotherapy System, SSRS, CT-on-Rails, Metastatic Spine Disease, Spinal Neoplasms, Radiation Therapy, Trilogy, Cancer, Breast Cancer, Gastrointestinal Cancer, Genitourinary Disease, Lung Cancer, Lymphoma, Melanoma, Sarcoma, Spinal Cancer
- Medical subject headings
- Spinal Neoplasms, Spinal Diseases, Neoplasms, Breast Neoplasms, Gastrointestinal Neoplasms, Urogenital Diseases, Lung Neoplasms, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiation TherapyRadiation
Three radiation treatments guided by the CT-on-Rails or Trilogy procedure over a period of 2 weeks. Participants prescribed to receive 9 Gy x 3 so that a peripheral dose of 27 Gy is given to the tumor.
| Study group | Role | What they receive |
|---|---|---|
| Radiation Therapy | Experimental | Radiation Therapy using CT-on-Rails or Trilogy procedure. Participants prescribed to receive 9 Gy x 3 so that a peripheral dose of 27 Gy is given to the tumor. Receives: Radiation: Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Response (Pain Relief)
The validated Brief Pain Inventory (BPI), MD Anderson Symptom Inventory (MDASI), and SF-12v2 Health Survey used to assess changes in these indicators compared to pre-treatment baseline. Response determined by follow-up questionaires. Time to maximal pain relief is the time from the first day of irradiation until the lowest pain score for average pain after radiotherapy. The "worst pain score" from BPI used as the marker for treatment success or failure.
Measured: Baseline, 3, 6, 9, 12, 18, and 24 months, then every six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2007 (estimated)
- Study start25 Oct 2002
- Primary completion31 Oct 2028 (estimated)
- Study completion31 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- 150 participants (estimated)
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
- NCT00508443
- Sponsor's protocol ID
- ID02-446
- Other IDs
- NCI-2012-01584, ID02-446
- Status last verified
- Oct 2026
- First submitted
- 27 Jul 2007
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Wang XS, Rhines LD, Shiu AS, Yang JN, Selek U, Gning I, Liu P, Allen PK, Azeem SS, Brown PD, Sharp HJ, Weksberg DC, Cleeland CS, Chang EL. Stereotactic body radiation therapy for management of spinal metastases in patients without spinal cord compression: a phase 1-2 trial. Lancet Oncol. 2012 Apr;13(4):395-402. doi: 10.1016/S1470-2045(11)70384-9. Epub 2012 Jan 27.
PubMed 22285199Boehling NS, Grosshans DR, Allen PK, McAleer MF, Burton AW, Azeem S, Rhines LD, Chang EL. Vertebral compression fracture risk after stereotactic body radiotherapy for spinal metastases. J Neurosurg Spine. 2012 Apr;16(4):379-86. doi: 10.3171/2011.11.SPINE116. Epub 2012 Jan 6.
PubMed 22225488
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Evaluation of a Novel CT-On-Rails or Trilogy Stereotactic Spine Radiotherapy System (SSRS) for the Treatment of Metastatic Spine Disease
- ClinicalTrials.gov ID
- NCT00508443
- Acronym / sponsor ID
- ID02-446
- Conditions
- Spinal Neoplasms
- Keywords
- Stereotactic Spine Radiotherapy System, SSRS, CT-on-Rails, Metastatic Spine Disease, Spinal Neoplasms, Radiation Therapy, Trilogy, Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 25 Oct 2002 (actual)
- Primary completion
- 31 Oct 2028 (estimated)
- Study completion
- 31 Oct 2028 (estimated)
- First posted
- 30 Jul 2007 (estimated)
- Results
- Not posted in the source record
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 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.
Detailed description
CT-On-Rails or Trilogy 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 of registration on this study. You will also fill out a health survey (5 minutes), a symptom inventory ( 5 minutes), and a Brief Pain Inventory (5 minutes) within 1 week of registration.
A pretreatment feasibility study will first be performed to determine the precision, accuracy, and reproducibility with which the target volume and critical normal structures (e.g. spinal cord) can be positioned relative to the radiation beams for spine tumors; this will consist of a CT scan.
Patients will have a CT-simulation. The simulation is like a CT scan where a special body frame is used to keep the patient from moving during scanning and later treatment.
You will be asked questions about your medical history and have a complete neurological exam during your first consultation. The neurological exam involves testing upper and lower motor strength, sensation to light touch, reflexes, mental exam, and way you walk. MRI of the spine must be performed within 1 month of registration. You will be asked to complete 3 questionnaires to evaluate your symptoms and pain. Each questionnaire will take around 5 minutes to complete, and should be completed within 1 month of being enrolled in the study.
All patients will be treated with radiation therapy that is guided by the CT-on-Rails or Trilogy procedure. Patients will receive a CT scan immediately before the treatment in the same room of the treatment using CT-On-Rails or Trilogy. There will be a total of 3 treatments over a period of 2 weeks.
Monitoring of side effects will be focused on neurological, gastrointestinal, musculoskeletal, and hematological systems. Every attempt will be made to have the patient complete the prescribed course of radiation to maximize the beneficial effect of treatment. However, if there is severe side effects, radiation treatment will be stopped and patients will be taken off study.
You will have follow up visits once a week during radiation treatment, scheduled on the same day as radiation. After treatment, you will have telephone, mail, or follow-ups per fax scheduled at 2 and 4 weeks,and 2 months post radiation. You will have follow up visits scheduled at 3, 6, 9, 12, 18, and 24 months, then every six 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 neurologic function will be evaluated. Any pain medication you are taking will be noted. You will have an 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 and pain. Each questionnaire will take around 5 minutes to complete.
This is an investigational study. The CT-on-rails and Trilogy linear accelerator are FDA-approved medical devices and are commercially available, however, the way these two devices are being used is investigational. Up to 150 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 |
|---|---|---|
| Radiation Therapy | Experimental | Radiation: Radiation TherapyRadiation Therapy using CT-on-Rails or Trilogy procedure. Participants prescribed to receive 9 Gy x 3 so that a peripheral dose of 27 Gy is given to the tumor. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (13 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
- Patients already re-treated with radiation as part of this protocol will not be eligible for additional re-treatment
- Unstable spine requiring surgical stabilization.
- Sites outside the spine (eg. lung, liver) are not eligible for treatment
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 |
|---|---|---|
| Radiation TherapyThree radiation treatments guided by the CT-on-Rails or Trilogy procedure over a period of 2 weeks. Participants prescribed to receive 9 Gy x 3 so that a peripheral dose of 27 Gy is given to the tumor. | Radiation | Radiation Therapy |
Primary outcome
Patient Response (Pain Relief)
Time frame: Baseline, 3, 6, 9, 12, 18, and 24 months, then every six months
The validated Brief Pain Inventory (BPI), MD Anderson Symptom Inventory (MDASI), and SF-12v2 Health Survey used to assess changes in these indicators compared to pre-treatment baseline. Response determined by follow-up questionaires. Time to maximal pain relief is the time from the first day of irradiation until the lowest pain score for average pain after radiotherapy. The "worst pain score" from BPI used as the marker for treatment success or failure.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Derived from this study: PubMed 22285199Wang XS, Rhines LD, Shiu AS, Yang JN, Selek U, Gning I, Liu P, Allen PK, Azeem SS, Brown PD, Sharp HJ, Weksberg DC, Cleeland CS, Chang EL. Stereotactic body radiation therapy for management of spinal metastases in patients without spinal cord compression: a phase 1-2 trial. Lancet Oncol. 2012 Apr;13(4):395-402. doi: 10.1016/S1470-2045(11)70384-9. Epub 2012 Jan 27.
- Derived from this study: PubMed 22225488Boehling NS, Grosshans DR, Allen PK, McAleer MF, Burton AW, Azeem S, Rhines LD, Chang EL. Vertebral compression fracture risk after stereotactic body radiotherapy for spinal metastases. J Neurosurg Spine. 2012 Apr;16(4):379-86. doi: 10.3171/2011.11.SPINE116. Epub 2012 Jan 6.
- University of Texas MD Anderson Cancer Center WebsiteLink 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 Radiation Therapy 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 6 inclusion and 13 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: under way, not looking for participants, as of the sponsor's last update on 2 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Patient Response (Pain Relief) (time frame: Baseline, 3, 6, 9, 12, 18, and 24 months, then every six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00508443, which also lists 2 linked publications.
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 2 Oct 2026.