Metastatic Cancer
Conditions
Keywords
spinal cord metastases
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.
Interventions
OTHERquestionnaire administration
prior to radiosurgery, at radiosurgery completion, and then at subsequent follow-ups (3, 6, 9, 12, 18, and 24 months after treatment
PROCEDUREdiffusion tensor imaging
prior to initiating CyberKnife radiosurgery, at 6 weeks after CyberKnife therapy, and at 6 months after CyberKnife therapy
PROCEDUREfunctional magnetic resonance imaging
prior to CyberKnife, at 6 weeks, and 3 months after CyberKnife?, every 3 months for the first year, and every 6 months thereafter
RADIATIONhypo-fractionated SRS
two to three consecutive daily sessions within one week for 3 cohorts- Cohort 1 = 21 Gy; Cohort 2 = 24 Gy; Cohort 3 = 27 Gy
RADIATIONsingle-fraction SRS
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
Sponsors
United States Department of Defense
Boston Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum tolerated dose - single fraction | 6 weeks | Maximum tolerated dose of CyberKnife® hypofractionated stereotactic radiosurgery |
| Maximum tolerated dose - hypofraction | 6 weeks | Maximum tolerated dose of CyberKnife® hypofractionated stereotactic radiosurgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Spinal cord response | baseline and then at 6 weeks and 6 months after completion of treatment | Spinal cord response as measured by functional MRI |
Countries
United States
Outcome results
None listed