An interventional study of Spinal SBRT (Standard Dose) and Spinal SBRT (Higher Dose) in Spinal Tumor, sponsored by M.D. Anderson Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-12.
Sponsored by M.D. Anderson Cancer Center · Not applicable, Interventional, and Treatment
The goal of the first part of this clinical research study is to learn how to deliver more accurate radiation treatment of tumors in the spine. Researchers also want to learn how internal organs might move during radiation treatment.
The goal of the second part of this study is to learn if it is safe to allow slightly more radiation to the normal esophagus when spinal tumors close by are being treated. This may result in better tumor control.
Study Groups:
If you are found to be eligible to take part in this study, you will be assigned to a study group based on when you join this study. Up to 3 groups of 10 participants will be enrolled in the first part of the study, and up to 2 groups of 10 participants will be enrolled in the second part of the study. Only participants who will receive a single spinal SBRT treatment are eligible for the second part of the study.
The participants in the first part of the study will receive standard doses of radiation therapy to normal organs while treating the tumor. In the second part of the study, each new group will receive a higher dose of radiation to the esophagus than the group before it, if no intolerable side effects were seen.
Radiation Planning and Treatment:
Before starting radiation treatment, you will be asked to complete a questionnaire about any symptoms you might be having and any drugs that you are taking. It should take about 10 minutes to complete. After treatment, you will be given copies of the questionnaire to take with you, and asked to fill it out 1 time a week for the next 4 weeks. You should return the questionnaires by mail. Self-addressed stamped envelopes will be given to you.
During all radiation treatments, the images that are taken during your treatment will be closely analyzed after treatment is over. You will have 1 to 3 radiation treatment sessions depending on your doctor's decision.
If you are in the second part of the study, you will receive slightly more radiation than usual to the normal esophagus.
The rest of your radiation treatment planning and treatment delivery appointments will be unchanged. The dose given to the tumor and number of treatments you receive will be determined by your doctor, and is not affected by taking part in this study.
Follow-Up Visits:
After your radiation treatment schedule ends, you will return for follow-up visits at the following time points:
Additional follow up visits may be scheduled, if your doctor thinks they are needed.
At these visits, the following tests and procedures will be performed:
This is an investigational study. Radiation therapy is delivered using FDA-approved and commercially available methods. It is considered investigational to give increased radiation to the esophagus.
Up to 57 patients will take part in this study. All will be enrolled at MD Anderson.
105 studies on the registry are indexed under Spinal Cord Neoplasms; 27 are open to participants now.
This study's enrollment of 41 is below the median of 50 across 69 interventional studies indexed under Spinal Cord Neoplasms.
Browse Spinal Cord 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.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
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.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
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.
All patients receive CT-guided spinal SBRT using IMRT to maximize conformality of treatment plan to target volume, while sparing normal structures. Dose given to tumor and number of treatments received determined by patient's doctor. In second stage, characterize tolerance of esophagus to hypofractionated radiation doses through prospective constraint relaxation and toxicity monitoring. Data collected from Group 1 in first stage will give data on dose delivered to esophagus. Second stage of protocol will begin accrual once Group 1 has filled. Dose constraints used for Groups 3 allow higher dose. Dose constraints for Group 4 represent modest increase of esophageal dose maximums.
Radiation: Spinal SBRT (Higher Dose) · Procedure: Gold Seed Implantation · Behavioral: Questionnaires
Analysis performed of ExacTrac positioning system with and without fiducial guidance. Four dimensional CT datasets for simulation will allow use of data from this portion of protocol to characterize degree to which organ at risk (OAR) motion is relevant at each spinal level. 20 patients accrued in two groups of 10, with 10 patients in each rostral-caudal position in the spine (Group 1: T4-T12, Group 2: L1-L5). Imaging done with fiducial markers for this study will not impact patient management. Patients will treated with standard dose constraints to normal tissues.
Radiation: Spinal SBRT (Standard Dose) · Procedure: Gold Seed Implantation · Behavioral: Questionnaires
Group 1 and 2: Standard doses of radiation therapy to the normal esophagus while treating the tumor. Up to 2 groups of 10 participants enrolled.
Also known as: XRT
Group 3 and 4: Higher dose of radiation to esophagus than group before it, if no intolerable side effects were seen. 2 groups of 10 participants enrolled in the second part of study. Only participants who will receive a single spinal SBRT treatment are eligible for second part of study.
Also known as: XRT
4 gold seeds implanted into bones of spine: 2 gold seeds above and 2 gold seeds below the area of tumor to be treated.
Also known as: Fiducial implantation
Completion of questionnaire before radiation treatment starts, and 1 time a week for the next 4 weeks. It should take about 10 minutes to complete.
Also known as: Surveys
Overall Response at Protocol Treatment Site
Patients will be monitored at each follow-up visit, with MRI of the spine performed at each follow-up time point during the first year. Treated lesions will be classified as progressive (defined as \> 25% increased volume), stable (defined as radiographically unchanged), or smaller, and spinal tumor progression-free survival (PFS) will be calculated.
Time frame: 10 years and 9.5 months
A total of 41 patient enrolled to this study from Aug 3, 2012 to Jun 1, 2015. Stage 1 in 38 patient and stage 2 in 3 patients
| Milestone | Stage 1 | Stage 2 |
|---|---|---|
| Started | 38 | 3 |
| Completed | 35 | 3 |
| Not completed | 3 | 0 |
| Withdrew: Withdrawal by subject | 3 | 0 |
Patients will be monitored at each follow-up visit, with MRI of the spine performed at each follow-up time point during the first year. Treated lesions will be classified as progressive (defined as \> 25% increased volume), stable (defined as radiographically unchanged), or smaller, and spinal tumor progression-free survival (PFS) will be calculated.
| Participants | Stage 1 | Stage 2 |
|---|---|---|
| Stable disease | 23 | 2 |
| Progression disease | 7 | 0 |
| Unknown | 8 | 1 |
Collected over From date of protocol registration until the date of documented development of AEs in both treatment groups (sate 1 and Stage 2), assessed in every visit, approximately 3 years and 7 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Stage 1 | 18/38 (47.4%) | 0/38 (0%) | 10/38 (26.3%) |
| Stage 2 | 1/3 (33.3%) | 0/3 (0%) | 1/3 (33.3%) |
| Event | Stage 1 | Stage 2 |
|---|---|---|
| Chest pain, abdominal painRespiratory, thoracic and mediastinal disorders | 0/38 | 1/3 |
| FeverGeneral disorders | 2/38 | 0/3 |
| painNervous system disorders | 2/38 | 0/3 |
| weakness / DC diagnoses: new epidural diseaseMusculoskeletal and connective tissue disorders | 1/38 | 0/3 |
| Cathecholamine excess (causing severe swings in BP and obstipation)Metabolism and nutrition disorders | 1/38 | 0/3 |
| Failure to thriveGastrointestinal disorders | 1/38 | 0/3 |
| Foot dropMusculoskeletal and connective tissue disorders | 1/38 | 0/3 |
| GI bleedGastrointestinal disorders | 1/38 | 0/3 |
| HemoptysisRespiratory, thoracic and mediastinal disorders | 1/38 | 0/3 |
| Age, Categorical(Participants) | Stage 1 | Stage 2 | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 24 | 2 | 26 |
| >=65 years | 14 | 1 | 15 |
| Sex: Female, Male(Participants) | Stage 1 | Stage 2 | Total |
|---|---|---|---|
| Female | 17 | 1 | 18 |
| Male | 21 | 2 | 23 |
| Ethnicity (NIH/OMB)(Participants) | Stage 1 | Stage 2 | Total |
|---|---|---|---|
| Hispanic or Latino | 5 | 1 | 6 |
| Not Hispanic or Latino | 10 | 2 | 12 |
| Unknown or Not Reported | 23 | 0 | 23 |
| Race (NIH/OMB)(Participants) | Stage 1 | Stage 2 | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 1 |
| Asian | 2 | 0 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 2 | 0 | 2 |
| White | 29 | 2 | 31 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 4 | 1 | 5 |
| Region of Enrollment(participants) | Stage 1 | Stage 2 | Total |
|---|---|---|---|
| United States | 38 | 3 | 41 |
PDFs hosted by the registry, ClinicalTrials.gov.
This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.