A Prospective Study Using Implanted Fiducial Markers to Assess Treatment Accuracy and Esophageal Toxicity in Spinal Stereotactic Body Radiation Therapy
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 2 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 2 groups of participants in the first part of the study will receive standard doses of
radiation therapy to the normal esophagus while treating the tumor. Each new group after
that will receive a higher dose of radiation to the esophagus than the group before it, if
no intolerable side effects were seen.
Gold Seed Implantation:
A needle will be used to place 4 gold seeds into the bones of your spine: 2 gold seeds above
and 2 gold seeds below the area of the tumor to be treated. The area will be numbed with
anesthetic or you may receive conscious sedation. No hospital stay is required. Only 1
implantation procedure is necessary.
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 gold seed markers will be used to try and deliver more
accurate radiation treatment. 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.
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. Gold seed markers are FDA approved and currently used to
help line up radiation treatments in multiple parts of the body, including for treatment of
prostate cancer. Studying the level of effectiveness of gold seed markers in spinal SBRT is
Radiation therapy is delivered using FDA-approved and commercially available methods. It is
considered investigational to give increased radiation to the esophagus.
Up to 40 patients will take part in this study. All will be enrolled at MD Anderson.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Assess Use of Implanted Fiducial Markers in Treatment Planning and Delivery Workflow for Frame-Based Spinal Stereotactic Body Radiation Therapy (Spinal SBRT)
Establish platform and perform analysis of the ExacTrac positioning system with and without fiducial guidance. Patients 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.
Paul Brown, MD
UT MD Anderson Cancer Center
United States: Food and Drug Administration
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