Stereotactic Body Radiation Therapy (SBRT) for Tumors Near the Spinal Cord

Study Overview
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Brief Summary
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The purpose of this research study is to determine if Stereotactic Body Radiation Therapy (SBRT) is a good way to treat tumors near the spinal cord. Patients will either receive a single treatment or 25 days of treatment given once-a-day, Monday through Friday for about 5 continuous weeks. Our protocol uses life expectancy, patient preference, and tumor size to determine whether SBRT is delivered with 1 or 25 treatments. The single treatment dose is 15 Gy. The 25 treatment group is 70 Gy at 2.8 Gy/treatment.

Detailed Description
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This protocol is a study of the use of Stereotactic Body Radiation Therapy (SBRT) for all types of primary or metastatic tumors near the spinal cord. The major goal of this study is to evaluate the efficacy and toxicity of a specific SBRT program in a prospective manner. The main outcome variables in this study are pain and neurologic function. A major issue in delivering SBRT is the number of treatment sessions. There are advantages and disadvantages to both single and multi treatment programs. In this protocol, patients are offered SBRT with either a single treatment or 25 treatment days. This study is not designed to compare different SBRT schedules. A single treatment program is more convenient and likely to relieve symptoms sooner than a multi-session program. A program with 25 treatments may produce better long-term results. Our protocol uses life expectancy, patient preference, and tumor size to determine whether SBRT is delivered with 1 or 25 treatments.

Official Title
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Stereotactic Body Radiation Therapy for Tumors Near the Spinal Cord

Conditions
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Spinal Tumors

Intervention / Treatment
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* Radiation: Stereotactic Body Radiation Therapy
* Radiation: Stereotactic Body Radiation Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Informed consent to participate in this protocol Patient of all ages are eligible All tumor types are eligible Patients with prior spine radiotherapy and/or surgery to the involved area are eligible The tumor target must be visible on MRI or CT scan Stereotactic Body Radiation Therapy (SBRT) on this protocol may produce a better outcome than conventional radiotherapy Exclusion Criteria: Patients who are likely to have a satisfactory outcome with surgical resection, embolization, or radiofrequency ablation without the addition of radiotherapy Tumor size, shape, or location is such that it is not reasonable to think the patient may benefit from SBRT as given in this protocol The full extent of the tumor cannot be visualized on MRI or CT scan Delaying radiotherapy for the time that it takes to start SBRT may compromise outcome compared to starting conventional radiotherapy immediately The patient cannot be positioned reproducibly due to pain or other factors
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Treatment Group<br>15 Gy dose in one stereotactic body radiation treatment | Radiation: Stereotactic Body Radiation Therapy<br>* 15 Gy in one treatment<br>|
| Experimental: 25 Treatments Group<br>25 treatments, given once a day, Monday through Friday for about five weeks; Dose: 70 Gy at 2.8 Gy/treatment | Radiation: Stereotactic Body Radiation Therapy<br>* Dose: 70 Gy at 2.8 Gy/treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity | Toxicities were graded using the RTOG-EORTC (Radiation Therapy Oncology Group-European Organization for Research and Treatment of Cancer) system and a descriptive system with which we coded any complication as mild, moderate, or severe based on our informal assessment of the complication's effect on overall quality of life. We assessed toxicity as acute meaning during treatment and late meaning several months after treatment ended. | 2 yrs | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local Control | Number of tumor sites with no evidence of progression of tumor at the site of radiosurgery | 1 year | 
| Neurologic Function | Number of patients with a change in neurological function of those who presented with a neurologic deficit from tumor compression. The McCormack score was noted for each patient and the interval change was determined informally as no neurological deficit, better, worse, or unchanged as noted below. | 2 years | 
| Pain Relief | Number of patients who reported pain at baseline and reported experienced relief after treatment. Pain was defined on a 10 point scale with 0 being no pain and 10 being worst pain imaginable. Pain relief is defined as reporting a lower level of pain than that reported at baseline. | 12 weeks | 
| Overall One Year Survival | Number of patients alive at one year after treatment | One year |