Stereotactic Radiosurgery in Treating Patients With Spinal Metastases
Phase 1
Completed
- Conditions
- Metastatic Cancer
- Interventions
- Other: questionnaire administrationProcedure: diffusion tensor imagingProcedure: functional magnetic resonance imagingRadiation: single-fraction SRSRadiation: hypo-fractionated SRS
- Registration Number
- NCT00853528
- Lead Sponsor
- Boston Medical Center
- Brief Summary
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.
- Detailed Description
OBJECTIVES:
* To implement CyberKnife® technology for improving palliation in patients with spinal metastases.
* To determine the maximum tolerated dose of CyberKnife® hypofractionated stereotactic radiosurgery in these patients.
* To evaluate functional and diffusion MRI parameters in the spinal cord and tumor after treatment with Cyberknife® radiosurgery.
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
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
- No more than 2 adjacent spinal levels involved by a single tumor
-
Involvement of ≤ 3 separate sites (e.g., C5, T5, and T12)
-
-
Tumor size ≤ 5 cm
-
PATIENT CHARACTERISTICS:
- Karnofsky performance status 60-100%
- Life expectancy ≥ 6 months
- Negative pregnancy test
- Fertile patients must use effective contraception
- Must be ambulatory
Exclusion Criteria
- Not pregnant or nursing
- No spinal instability
- No rapid neurological decline
- No bony retropulsions causing neurological abnormalities
- No total paraplegia for > 48 hours
- No psychological issues that would preclude completion of study treatment
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior treatment for spinal tumor that would result in potential overlap of radiotherapy fields
- No treatment that is expected to exceed spinal cord tolerance or other regional normal tissue tolerance
- No tumors that are exquisitely radiosensitive and controlled with conventional radiotherapy (e.g., lymphoma, leukemia, multiple myeloma, or germ cell tumors)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Single-fraction radiosurgery; 16 Gray single-fraction SRS 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 questionnaire administration 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 questionnaire administration 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; 16 Gray questionnaire administration 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 hypo-fractionated SRS 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 functional magnetic resonance imaging 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 questionnaire administration 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; 21 Gray diffusion tensor imaging 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 Hypo-fractionated radiosurgery; 21 Gray functional magnetic resonance imaging 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; 16 Gray diffusion tensor imaging 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 Single-fraction radiosurgery; 20 Gray single-fraction SRS 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 functional magnetic resonance imaging 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 questionnaire administration 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 Hypo-fractionated radiosurgery; 27 Gray hypo-fractionated SRS 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 Single-fraction radiosurgery; 16 Gray functional magnetic resonance imaging 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 Single-fraction radiosurgery; 18 Gray diffusion tensor imaging 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; 18 Gray single-fraction SRS 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 Hypo-fractionated radiosurgery; 24 Gray questionnaire administration 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 Single-fraction radiosurgery; 20 Gray diffusion tensor imaging 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 diffusion tensor imaging 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 functional magnetic resonance imaging 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 Single-fraction radiosurgery; 20 Gray functional magnetic resonance imaging 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 hypo-fractionated SRS 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 diffusion tensor imaging 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
- Primary Outcome Measures
Name Time Method Maximum tolerated dose - hypofraction 6 weeks Maximum tolerated dose of CyberKnife® hypofractionated stereotactic radiosurgery
Maximum tolerated dose - single fraction 6 weeks Maximum tolerated dose of CyberKnife® hypofractionated stereotactic radiosurgery
- Secondary Outcome Measures
Name Time Method Spinal cord response baseline and then at 6 weeks and 6 months after completion of treatment Spinal cord response as measured by functional MRI
Assessment of pain baseline and then at 3, 6, 9, 12, 18, and 24 months after completion of treatment Pain as measured by the Brief Pain Inventory and Roland scale
Trial Locations
- Locations (1)
Boston University Cancer Research Center
🇺🇸Boston, Massachusetts, United States