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| ID | Type | Description | Link |
|---|---|---|---|
| W81XWH-07-1-0342 | Other Grant/Funding Number | Dept of Defense | |
| CDR0000635267 | Other Identifier | BUMC |
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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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RATIONALE: Stereotactic radiosurgery can send x-rays directly to the tumor and cause less damage to normal tissue. It may also help patients with spinal metastases live more comfortably.
PURPOSE: This phase I trial is studying the side effects and best dose of stereotactic radiosurgery in treating patients with spinal metastases.
OBJECTIVES:
OUTLINE: Patients undergo placement of gold fiducial markers at the time of open surgical resection or percutaneous needle biopsy. Patients then undergo CyberKnife® hypofractionated stereotactic radiosurgery over 30-90 minutes daily for 2-3 days.
Patients undergo functional MRI and diffusion tensor imaging at baseline and then at 6 weeks and 6 months after completion of treatment. Patients also complete a pain questionnaire at baseline and then at 3, 6, 9, 12, 18, and 24 months after completion of treatment.
After completion of study treatment, patients are followed periodically for up to 2 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single-fraction radiosurgery; 16 Gray | Experimental | Subjects able to achieve the spinal cord dose constraints for single-fraction SRS stereotactic radiosurgery Radiation: stereotactic radiotherapy at 16 Gray Questionnaire administration diffusion tensor imaging functional magnetic resonance imaging |
|
| Hypo-fractionated radiosurgery; 21 Gray | Experimental | Subjects unable to achieve the spinal cord dose constraints for single-fraction radiosurgery (SRS), based on tumor location and expected tolerance dose to the adjacent normal tissue, will be offered hypo-fractionated SRS (3 fractions) Radiation: stereotactic radiotherapy Questionnaire administration diffusion tensor imaging functional magnetic resonance imaging hypo-fractionated radiation therapy at 21 Gray |
|
| Single-fraction radiosurgery; 18 Gray | Experimental | Subjects able to achieve the spinal cord dose constraints for single-fraction SRS stereotactic radiosurgery Radiation: stereotactic radiotherapy at 18 Gray Questionnaire administration diffusion tensor imaging functional magnetic resonance imaging |
|
| Single-fraction radiosurgery; 20 Gray |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| questionnaire administration | Other | prior to radiosurgery, at radiosurgery completion, and then at subsequent follow-ups (3, 6, 9, 12, 18, and 24 months after treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum tolerated dose - single fraction | Maximum tolerated dose of CyberKnife® hypofractionated stereotactic radiosurgery | 6 weeks |
| Maximum tolerated dose - hypofraction | Maximum tolerated dose of CyberKnife® hypofractionated stereotactic radiosurgery | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of pain | Pain as measured by the Brief Pain Inventory and Roland scale | baseline and then at 3, 6, 9, 12, 18, and 24 months after completion of treatment |
| Spinal cord response | Spinal cord response as measured by functional MRI |
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Inclusion Criteria:
DISEASE CHARACTERISTICS:
Histologically confirmed metastatic spinal tumor
Localized spinal metastasis, defined as one of the following:
Solitary spinal metastasis
Two contiguous spinal levels
Involvement of ≤ 3 separate sites (e.g., C5, T5, and T12)
Tumor size ≤ 5 cm
PATIENT CHARACTERISTICS:
Exclusion Criteria:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Minh-Tam Truong, MD | Boston Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston University Cancer Research Center | Boston | Massachusetts | 02118 | United States |
There is no plan to share individual participant data.
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| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D056324 | Diffusion Tensor Imaging |
| ID | Term |
|---|---|
| D059906 | Neuroimaging |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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This is a Phase I study with 2 parallel groups of dose escalation using a 3 +3 design to determine the maximum tolerated dose of the radiation with the FDA approved device. There are three dose cohorts in each group, thus 6 arms.
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| Experimental |
Subjects able to achieve the spinal cord dose constraints for single-fraction SRS stereotactic radiosurgery Radiation: stereotactic radiotherapy at 20 Gray Questionnaire administration diffusion tensor imaging functional magnetic resonance imaging |
|
| Hypo-fractionated radiosurgery; 24 Gray | Experimental | Subjects unable to achieve the spinal cord dose constraints for single-fraction radiosurgery (SRS), based on tumor location and expected tolerance dose to the adjacent normal tissue, will be offered hypo-fractionated SRS (3 fractions) Radiation: stereotactic radiotherapy Questionnaire administration diffusion tensor imaging functional magnetic resonance imaging hypo-fractionated radiation therapy at 24 Gray |
|
| Hypo-fractionated radiosurgery; 27 Gray | Experimental | Subjects unable to achieve the spinal cord dose constraints for single-fraction radiosurgery (SRS), based on tumor location and expected tolerance dose to the adjacent normal tissue, will be offered hypo-fractionated SRS (3 fractions) Radiation: stereotactic radiotherapy Questionnaire administration diffusion tensor imaging functional magnetic resonance imaging hypo-fractionated radiation therapy at 27 Gray |
|
| diffusion tensor imaging | Procedure | prior to initiating CyberKnife radiosurgery, at 6 weeks after CyberKnife therapy, and at 6 months after CyberKnife therapy |
|
| functional magnetic resonance imaging | Procedure | prior to CyberKnife, at 6 weeks, and 3 months after CyberKnife?, every 3 months for the first year, and every 6 months thereafter |
|
| hypo-fractionated SRS | Radiation | two to three consecutive daily sessions within one week for 3 cohorts- Cohort 1 = 21 Gy; Cohort 2 = 24 Gy; Cohort 3 = 27 Gy |
|
| single-fraction SRS | Radiation | two to three consecutive daily sessions within one week for 3 cohorts- for 3 cohorts- Cohort 1 = 16 Gy; Cohort 2 = 18 Gy; Cohort 3 = 20 Gy |
|
| baseline and then at 6 weeks and 6 months after completion of treatment |
| D038524 |
| Diffusion Magnetic Resonance Imaging |
| D008279 | Magnetic Resonance Imaging |
| D014054 | Tomography |
| D003943 | Diagnostic Techniques, Neurological |
| D008919 | Investigative Techniques |