Stereotactic Radiosurgery in Treating Patients With Spinal Metastases
Completed · Phase 1
Conditions studied: Metastatic Cancer
In brief
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.
Key facts
- Study ID
- NCT00853528
- Run by
- Boston Medical Center
- People needed
- 18
- Starts
- 2009-01-01
- Expected to finish
- 2017-06-01
- Last updated by the study team
- 2017-07-19
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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)
Where it is running
- Boston University Cancer Research Center — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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