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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Treatment Group | Experimental | 15 Gy dose in one stereotactic body radiation treatment |
|
| 25 Treatments Group | Experimental | 25 treatments, given once a day, Monday through Friday for about five weeks; Dose: 70 Gy at 2.8 Gy/treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stereotactic Body Radiation Therapy | Radiation | 15 Gy in one treatment |
| |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert J Amdur, MD | University of Florida- Radiation Oncology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida | Gainesville | Florida | 32610 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Single Treatment Group | 15 Gy dose of radiation in one treatment. Patients were offered the option of which arm they wished to participate in. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Single Treatment Group | 15 Gy dose of radiation in one treatment. Patients were offered the option of which arm they wished to participate in. |
| BG001 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Categorical | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | participants | 2 yrs |
|
2 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Single Treatment Group | 15 Gy dose of radiation in one treatment. Patients were offered the option of which arm they wished to participate in. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Grade 1 Nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bridget Fitzgerald, Clinical trials coordinator | University of Florida, Dept. of Radiation Oncology | 352-265-0680 | 87829 | fitzgb@shands.ufl.edu |
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| ID | Term |
|---|---|
| D013120 | Spinal Cord Neoplasms |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
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| Stereotactic Body Radiation Therapy |
| Radiation |
Dose: 70 Gy at 2.8 Gy/treatment |
|
| 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 |
| BG002 | Total | Total of all reporting groups |
| participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Gender | Number | participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Local Control | Number of tumor sites with no evidence of progression of tumor at the site of radiosurgery | Posted | Number | tumors | 1 year | tumors | Participants |
|
|
|
| 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. | 6 patients presented with tumor-related deficits before treatment. | Posted | Number | participants | 2 years |
|
|
|
| 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. | Patients who reported pain at baseline | Posted | Number | participants | 12 weeks |
|
|
|
| Secondary | Overall One Year Survival | Number of patients alive at one year after treatment | Posted | Number | participants | One year |
|
|
|
| 0 |
| 21 |
| 14 |
| 21 |
| EG001 | 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 | 0 | 0 | 0 |
| Grade 2 Pharyngitis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
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| D013118 |
| Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D013514 |
| Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| Title | Measurements |
|---|---|
|