A Phase 1/2 interventional study of Stereotactic Body Radiotherapy in Spinal Neoplasms, sponsored by M.D. Anderson Cancer Center. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2025-10-24.
Sponsored by M.D. Anderson Cancer Center · Phase 1/2, Interventional, and Treatment
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:
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.
18 studies on the registry are indexed under Spinal Neoplasms; 5 are open to participants now.
This study's enrollment of 71 is close to the median of 71 across 11 interventional studies indexed under Spinal Neoplasms.
Browse Spinal Neoplasms studies →M.D. Anderson Cancer Center is the lead sponsor of 3,047 studies on the registry; 578 are open to participants now.
Of its 612 completed or terminated interventional studies of FDA-regulated products, 409 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Procedure: Stereotactic Body Radiotherapy
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.
Also known as: SBRT
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
Time frame: 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
Time frame: 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
Time frame: Up to 24 months after radiation therapy
| Milestone | Single Session Stereotactic Body Radiotherapy (SBRT) |
|---|---|
| Started | 71 |
| Completed | 71 |
| Not completed | 0 |
To measure 6-month complete pain relief, i.e., 6-month "pain worst" from the BPI being zero
| Participants | Single Session Stereotactic Body Radiotherapy (SBRT) |
|---|---|
| Complete Pain Relief Using Stereotactic Body Radiotherapy (SBRT) to Treat Spine and Para- Spinal Tumors in a Single Session | 18 |
Local tumor control rate as measured based on spinal MRI showing absence of progression
| Participants | Single Session Stereotactic Body Radiotherapy (SBRT) |
|---|---|
| Local Tumor Control Rate | 48 |
Evidence of paralysis (Grade 4 motor neuropathy) casued by radiation myelitis
| Participants | Single Session Stereotactic Body Radiotherapy (SBRT) |
|---|---|
| Paralysis (Grade 4 Motor Neuropathy) | 0 |
Collected over Approximately 1 year, 9 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Single Session Stereotactic Body Radiotherapy (SBRT) | 63/71 (88.7%) | 7/71 (9.9%) | 0/71 (0%) |
| Event | Single Session Stereotactic Body Radiotherapy (SBRT) |
|---|---|
| Esophageal strictureGastrointestinal disorders | 2/71 |
| DiarrheaGeneral disorders | 2/71 |
| Nephrostomy tube placement, Malfunctioning prostomyRenal and urinary disorders | 1/71 |
| HemorrhageBlood and lymphatic system disorders | 1/71 |
| Neroforaminal stenosis and nerve root compressionMusculoskeletal and connective tissue disorders | 1/71 |
| Age, Categorical(Participants) | Single Session Stereotactic Body Radiotherapy (SBRT) |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 51 |
| >=65 years | 20 |
| Sex: Female, Male(Participants) | Single Session Stereotactic Body Radiotherapy (SBRT) |
|---|---|
| Female | 30 |
| Male | 41 |
| Ethnicity (NIH/OMB)(Participants) | Single Session Stereotactic Body Radiotherapy (SBRT) |
|---|---|
| Hispanic or Latino | 6 |
| Not Hispanic or Latino | 15 |
| Unknown or Not Reported | 50 |
| Race (NIH/OMB)(Participants) | Single Session Stereotactic Body Radiotherapy (SBRT) |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 4 |
| White | 64 |
| More than one race | 1 |
| Unknown or Not Reported | 2 |
| Region of Enrollment(participants) | Single Session Stereotactic Body Radiotherapy (SBRT) |
|---|---|
| United States | 71 |
PDFs hosted by the registry, ClinicalTrials.gov.
This study is completed, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.
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