Spinal Tumors
Conditions
Brief summary
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
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.
Interventions
RADIATIONStereotactic Body Radiation Therapy
15 Gy in one treatment
Sponsors
University of Florida
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Toxicity | 2 yrs | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Local Control | 1 year | Number of tumor sites with no evidence of progression of tumor at the site of radiosurgery |
| Neurologic Function | 2 years | 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. |
| Pain Relief | 12 weeks | 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. |
| Overall One Year Survival | One year | Number of patients alive at one year after treatment |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Single Treatment Group 15 Gy dose of radiation in one treatment. Patients were offered the option of which arm they wished to participate in. | 21 |
| 25 Treatments Group 25 treatments, given once a day, Monday through Friday for about five weeks; Dose: 70 Gy at 2.8 Gy/treatment. Patients were offered the option to participate in which arm they preferred. | 0 |
| Total | 21 |
Baseline characteristics
| Characteristic | Total | Single Treatment Group |
|---|---|---|
| Age Categorical <=18 years | 0 participants | 0 participants |
| Age Categorical >=65 years | 8 participants | 8 participants |
| Age Categorical Between 18 and 65 years | 13 participants | 13 participants |
| Age Continuous | 58.5 years STANDARD_DEVIATION 15.9 | 58.5 years STANDARD_DEVIATION 15.9 |
| Gender Female | 9 participants | 9 participants |
| Gender Male | 12 participants | 12 participants |
| Region of Enrollment United States | 21 participants | 21 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 14 / 21 | 0 / 0 |
| serious Total, serious adverse events | 0 / 21 | 0 / 0 |
Outcome results
Primary
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.
Time frame: 2 yrs
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Single Treatment Group | Toxicity | mild acute toxicity | 14 participants |
| Single Treatment Group | Toxicity | moderate acute toxicity | 0 participants |
| Single Treatment Group | Toxicity | severe acute toxicity | 0 participants |
| Single Treatment Group | Toxicity | Late toxicity | 0 participants |
Secondary
Local Control
Number of tumor sites with no evidence of progression of tumor at the site of radiosurgery
Time frame: 1 year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Single Treatment Group | Local Control | 24 tumors |
Secondary
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.
Time frame: 2 years
Population: 6 patients presented with tumor-related deficits before treatment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Single Treatment Group | Neurologic Function | improved neurologic function | 0 participants |
| Single Treatment Group | Neurologic Function | unchanged neurologic function | 6 participants |
| Single Treatment Group | Neurologic Function | worse neurologic function | 0 participants |
Secondary
Overall One Year Survival
Number of patients alive at one year after treatment
Time frame: One year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Single Treatment Group | Overall One Year Survival | 5 participants |
Secondary
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.
Time frame: 12 weeks
Population: Patients who reported pain at baseline
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Single Treatment Group | Pain Relief | 6 participants |