Phase I clinical evaluation of near-simultaneous computed tomographic image-guided stereotactic body radiotherapy for spinal metastases
| Autor: | Barry W. Brown, Moshe H. Maor, Ming Fwu Lii, Eric L. Chang, Anita Mahajan, Jeffrey S. Weinberg, Almon S. Shiu, Leni A. Mathews, James D. Cox, Ehud Mendel, Laurence D. Rhines |
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| Rok vydání: | 2004 |
| Předmět: |
Adult
Male Cancer Research medicine.medical_specialty Adolescent medicine.medical_treatment Phases of clinical research Spinal disease Stereotaxic Techniques Myelopathy Confidence Intervals Paralysis medicine Humans Radiology Nuclear Medicine and imaging Aged Spinal Neoplasms Radiation business.industry Isocenter Middle Aged Spinal cord medicine.disease Radiation therapy medicine.anatomical_structure Oncology Feasibility Studies Female Radiology Tomography Radiotherapy Conformal medicine.symptom Tomography X-Ray Computed business Nuclear medicine |
| Zdroj: | International Journal of Radiation Oncology*Biology*Physics. 59:1288-1294 |
| ISSN: | 0360-3016 |
| DOI: | 10.1016/j.ijrobp.2004.04.025 |
| Popis: | Purpose To evaluate in a Phase I study the safety, feasibility, and patient-positioning accuracy of treating patients with intensity-modulated, near-simultaneous, computed tomographic (CT) image-guided stereotactic body radiotherapy (SBRT). Patients and methods Fifteen consecutive patients with metastatic spinal disease who met protocol eligibility criteria were entered into a Phase I clinical trial. Each patient received five treatments of intensity-modulated, near-simultaneous CT image-guided SBRT, for a total of 75 treatments with 90 isocenter setups during the course of the study. Patients uniformly received 30 Gy (if possible) of radiotherapy in 5 fractions to the clinical target volume. The total dose was constrained by limiting the spinal cord to a maximum dose of 10 Gy. To verify correct daily patient positioning before each treatment and to determine the daily treatment setup error after radiation delivery, axial CT scans were taken before and immediately after each treatment without moving the patient from the treatment position, for comparison with the planning CT scan. Toxicity was measured using the Common Toxicity Criteria, the Late Effects of Normal Tissue scoring system and a neurologic function scale. Follow-up was conducted 4 weeks after completion of SBRT, and then 2, 3, 6, 9, 12, and every 6 months thereafter. Results The procedure was technically feasible to perform in all patients. No neurologic toxicity was observed in any patient. The median follow-up time was 9 months (range 6–16). The Clopper-Pearson upper bound on the probability of paralysis with 95% confidence is no greater than 0.181. The positional setup error was determined to be within 1 mm of planning isocenter. Conclusions This Phase I study shows that intensity-modulated, near simultaneous, CT image-guided SBRT is a feasible, and highly precise technique for the noninvasive treatment of spinal metastases. Although no paralysis has developed in the 15 patients treated, continued monitoring for spinal cord toxicity is warranted, as larger numbers of patients will be needed to more precisely define the upper bound on the probability of spinal cord myelopathy. |
| Databáze: | OpenAIRE |
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