Spinal TumorNCT01624220
A Prospective Study Using Implanted Fiducial Markers to Assess Treatment Accuracy and Esophageal Toxicity in Spinal Stereotactic Body Radiation Therapy
A study testing Spinal SBRT (Standard Dose), Spinal SBRT (Higher Dose) and Gold Seed Implantation in people with Spinal Tumor, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Tumor
- What is being tested?
- Spinal SBRT (Standard Dose), Spinal SBRT (Higher Dose) and Gold Seed Implantation
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Aug 2012to 14 Apr 2023
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- STAGE 1: >/= 18 years old
- STAGE 1: Pathologically confirmed diagnosis of cancer, including, but not limited to non-small cell lung cancer, breast, prostate, renal cell, melanoma, gastrointestinal, sarcoma, thyroid, head and neck primary, and carcinoma of unknown primary
- STAGE 1: Signed informed consent
- STAGE 2: 1-3 above, and Patients undergoing single fraction spinal SBRT
Who cannot join
- STAGE 1: Patient with radiosensitive histologies (lymphoma, multiple myeloma, small cell carcinomas, germ cell tumors)
- STAGE 1: Extensive (> 50%) height loss of the involved vertebral body
- STAGE 1: Inability to tolerate lying flat on treatment table for greater than 30 minutes
- STAGE 1: Pregnancy
- STAGE 2: Prior irradiation of the spine site and level to be treated
- STAGE 2: Patients with primary disease arising in the posterior elements of the VB in question
- STAGE 2: History of Barrett's esophagus, esophageal webbing, stricture, or fistula
- STAGE 2: Prior radiation to the esophagus
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
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.
Read the detailed description
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:
- At 3 months
- Then, every 3 months for 1 year
- Every 6 months during year 2, and then
- 1 time a year after that, for as long as possible
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:
- Any updates to your medical history will be recorded and you will be asked about any side effects you may be having.
- Your performance status will be recorded.
- Your completed symptom questionnaires will be reviewed.
- You will have a physical, including measurement of your vital signs
- You will have a neurological exam.
- You will have follow-up imaging (such as an MRI) to check the status of the disease.
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.
- Conditions
- Spinal Tumor
- Being tested
- Spinal SBRT (Standard Dose), Spinal SBRT (Higher Dose), Gold Seed Implantation, Questionnaires
- Keywords
- Spinal tumor, Tumor of the mid or lower spine, Non-small cell lung cancer, Breast cancer, Prostate cancer, Renal cell cancer, Melanoma, Gastrointestinal cancer, Sarcoma, Thyroid cancer, Head and neck primary cancer, Carcinoma of unknown primary, Fiducial markers, Gold seed markers, Spinal stereotactic body radiation therapy, Spinal SBRT, Stereotactic Radiotherapy
- Medical subject headings
- Spinal Cord Neoplasms, Carcinoma, Non-Small-Cell Lung, Breast Neoplasms, Prostatic Neoplasms, Carcinoma, Renal Cell, Melanoma, Gastrointestinal Neoplasms, Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal SBRT (Standard Dose)Radiation
Also called XRT
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.
Spinal SBRT (Higher Dose)Radiation
Also called 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.
Gold Seed ImplantationProcedure or surgery
Also called Fiducial implantation
4 gold seeds implanted into bones of spine: 2 gold seeds above and 2 gold seeds below the area of tumor to be treated.
QuestionnairesBehavioural
Also called Surveys
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.
| Study group | Role | What they receive |
|---|---|---|
| Hypofractionated Radiation | Experimental | 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. Receives: Radiation: Spinal SBRT (Higher Dose); Procedure: Gold Seed Implantation; Behavioral: Questionnaires |
| ExacTrac Positioning System | Experimental | 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. Receives: Radiation: Spinal SBRT (Standard Dose); Procedure: Gold Seed Implantation; Behavioral: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 years and 9.5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2012 (estimated)
- Study start3 Aug 2012
- Primary completion14 Apr 2023
- Study completion14 Apr 2023
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 TumorStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 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
- NCT01624220
- Sponsor's protocol ID
- 2012-0190
- Other IDs
- NCI-2012-01244
- Status last verified
- Apr 2026
- First submitted
- 18 Jun 2012
- Last updated
- 12 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study Using Implanted Fiducial Markers to Assess Treatment Accuracy and Esophageal Toxicity in Spinal Stereotactic Body Radiation Therapy
- ClinicalTrials.gov ID
- NCT01624220
- Acronym / sponsor ID
- 2012-0190
- Conditions
- Spinal Tumor
- Keywords
- Spinal tumor, Tumor of the mid or lower spine, Non-small cell lung cancer, Breast cancer, Prostate cancer, Renal cell cancer, Melanoma, Gastrointestinal cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 3 Aug 2012 (actual)
- Primary completion
- 14 Apr 2023 (actual)
- Study completion
- 14 Apr 2023 (actual)
- First posted
- 20 Jun 2012 (estimated)
- Results
- Posted 12 May 2026
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 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.
Detailed description
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:
- At 3 months
- Then, every 3 months for 1 year
- Every 6 months during year 2, and then
- 1 time a year after that, for as long as possible
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:
- Any updates to your medical history will be recorded and you will be asked about any side effects you may be having.
- Your performance status will be recorded.
- Your completed symptom questionnaires will be reviewed.
- You will have a physical, including measurement of your vital signs
- You will have a neurological exam.
- You will have follow-up imaging (such as an MRI) to check the status of the disease.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypofractionated Radiation | Experimental | Radiation: Spinal SBRT (Higher Dose), Procedure: Gold Seed Implantation, Behavioral: QuestionnairesAll 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. |
| ExacTrac Positioning System | Experimental | Radiation: Spinal SBRT (Standard Dose), Procedure: Gold Seed Implantation, Behavioral: QuestionnairesAnalysis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- STAGE 1: >/= 18 years old
- STAGE 1: Pathologically confirmed diagnosis of cancer, including, but not limited to non-small cell lung cancer, breast, prostate, renal cell, melanoma, gastrointestinal, sarcoma, thyroid, head and neck primary, and carcinoma of unknown primary
- STAGE 1: Signed informed consent
- STAGE 2: 1-3 above, and Patients undergoing single fraction spinal SBRT
Key exclusion criteria (8 listed)
- STAGE 1: Patient with radiosensitive histologies (lymphoma, multiple myeloma, small cell carcinomas, germ cell tumors)
- STAGE 1: Extensive (> 50%) height loss of the involved vertebral body
- STAGE 1: Inability to tolerate lying flat on treatment table for greater than 30 minutes
- STAGE 1: Pregnancy
- STAGE 2: Prior irradiation of the spine site and level to be treated
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 |
|---|---|---|
| Spinal SBRT (Standard Dose)Also: XRTGroup 1 and 2: Standard doses of radiation therapy to the normal esophagus while treating the tumor. Up to 2 groups of 10 participants enrolled. | Radiation | ExacTrac Positioning System |
| Spinal SBRT (Higher Dose)Also: XRTGroup 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. | Radiation | Hypofractionated Radiation |
| Gold Seed ImplantationAlso: Fiducial implantation4 gold seeds implanted into bones of spine: 2 gold seeds above and 2 gold seeds below the area of tumor to be treated. | Procedure or surgery | ExacTrac Positioning System, Hypofractionated Radiation |
| QuestionnairesAlso: SurveysCompletion of questionnaire before radiation treatment starts, and 1 time a week for the next 4 weeks. It should take about 10 minutes to complete. | Behavioural | ExacTrac Positioning System, Hypofractionated Radiation |
Primary outcome
Overall Response at Protocol Treatment Site
Time frame: 10 years and 9.5 months
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- 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 study testing Spinal SBRT (Standard Dose), Spinal SBRT (Higher Dose) and Gold Seed Implantation in people with Spinal Tumor, 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 4 inclusion and 8 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 12 May 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 May 2026). 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?
Overall Response at Protocol Treatment Site (time frame: 10 years and 9.5 months). 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 12 May 2026; AzTrials last refreshed its copy on 5 Nov 2026.