Study Results
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View full resultsBasic Information
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COMPLETED
NA
43 participants
INTERVENTIONAL
2005-04-30
2016-09-30
Brief Summary
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Detailed Description
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Dose prescription to tumor is based upon maximal dose received by 0.5 cc of spinal cord and whether patient has had prior radiation therapy to that area:
Phase I - Motion and QA Study: 20-25 Gy in 5 fractions/10-20 patients/previous RT = \<50% CTV dose/No previous RT = \<80% CTV dose.
Phase II - 9-24 Gy in 1 fraction/30 total in order to have 20 evaluable patients (15 patients with prior RT and 15 without prior RT/previous RT = 8 Gy/No previous RT = 10 Gy.
\# Motion and QA study will treat CTV to 20-25 Gy in 5 fractions to study intrafraction motion for QA of single fraction administration. This will define treatment margins for single fraction radiosurgery.
\*Previous RT:
* greater than six months since completion of RT
* at least 20 Gy, but no more than 50 Gy
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Spinal Radiosurgery
Patients will be fitted in a custom immobilization device. A CT simulation scan will then be performed to pinpoint intended radiosurgery target producing a computer optimized radiation plan to be confirmed by planning radiation physicist. Patient will then be placed in their immobilization device and aligned with the treatment planning position. Patient then receives radiosurgery. Treatment delivery will be divided into components of 3-5Gy with repeat CT based localization in between each of these components. For all patients, a nominal prescription dose of 24Gy will be entered into the tomotherapy cost function. Once the plan that provides maximal spinal sparing has been generated, the plan will be renormalized to produce no more than 8Gy (prior RT) or 10Gy (no prior RT) to 0.5cc of spinal cord by dividing the single fraction treatment into fractions of 3-5Gy.
Radiosurgery
Phase I: 20-25 Gy in 5 fractions
Phase II: 9-24 GY in 1 fraction
Interventions
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Radiosurgery
Phase I: 20-25 Gy in 5 fractions
Phase II: 9-24 GY in 1 fraction
Eligibility Criteria
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Inclusion Criteria
2. ECOG performance status of less than or equal to 2
3. Age greater than 18
4. Life expectancy greater than 12 weeks
5. Subjects given written informed consent
Exclusion Criteria
2. Insufficient recovery from all active toxicities of prior therapies
3. Epidural spinal cord compression requiring immediate neurosurgical decompression. If a patient requires immediate surgery for neurologic compromise, they may still be eligible post operatively if tumor was incompletely resected.
4. Patient is non-ambulatory. Optimization of pretreatment neurologic function with steroids is allowed. Ambulation with assistance of walker or cane is allowed.
5. Patient is pregnant and it is judged by the treating Radiation Oncologist that spinal radiosurgery would place the fetus in unacceptable danger.
19 Years
ALL
No
Sponsors
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Health Services Foundation
UNKNOWN
The Kirklin Clinic at Acton Road
UNKNOWN
University of Alabama at Birmingham
OTHER
Responsible Party
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John Fiveash, MD
Professor and Vice Chair, University of Alabama at Birmingham Department of Radiation Oncology
Principal Investigators
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John B. Fiveash, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham
Locations
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University of Alabama at Birmingham/The Kirklin Clinic at Acton Road
Birmingham, Alabama, United States
Countries
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References
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Abbatucci JS, Delozier T, Quint R, Roussel A, Brune D. Radiation myelopathy of the cervical spinal cord: time, dose and volume factors. Int J Radiat Oncol Biol Phys. 1978 Mar-Apr;4(3-4):239-48. doi: 10.1016/0360-3016(78)90144-x. No abstract available.
Ang KK, Jiang GL, Feng Y, Stephens LC, Tucker SL, Price RE. Extent and kinetics of recovery of occult spinal cord injury. Int J Radiat Oncol Biol Phys. 2001 Jul 15;50(4):1013-20. doi: 10.1016/s0360-3016(01)01599-1.
Bilsky MH, Yamada Y, Yenice KM, Lovelock M, Hunt M, Gutin PH, Leibel SA. Intensity-modulated stereotactic radiotherapy of paraspinal tumors: a preliminary report. Neurosurgery. 2004 Apr;54(4):823-30; discussion 830-1. doi: 10.1227/01.neu.0000114263.01917.1e.
Daut RL, Cleeland CS, Flanery RC. Development of the Wisconsin Brief Pain Questionnaire to assess pain in cancer and other diseases. Pain. 1983 Oct;17(2):197-210. doi: 10.1016/0304-3959(83)90143-4.
Delattre JY, Rosenblum MK, Thaler HT, Mandell L, Shapiro WR, Posner JB. A model of radiation myelopathy in the rat. Pathology, regional capillary permeability changes and treatment with dexamethasone. Brain. 1988 Dec;111 ( Pt 6):1319-36. doi: 10.1093/brain/111.6.1319.
Gerszten PC, Ozhasoglu C, Burton SA, Vogel WJ, Atkins BA, Kalnicki S, Welch WC. CyberKnife frameless stereotactic radiosurgery for spinal lesions: clinical experience in 125 cases. Neurosurgery. 2004 Jul;55(1):89-98; discussion 98-9.
Glanzmann C, Aberle HG, Horst W. The risk of chronic progressive radiation myelopathy. Strahlentherapie. 1976 Oct;152(4):363-72.
Nieder C: Recommendation of Human Spinal Cord Re-irradiation Dose Based on Data From 39 Patients. Int J Radiat Oncol Biol Phys 57:373, 2003
Schultheiss TE, Stephens LC. Invited review: permanent radiation myelopathy. Br J Radiol. 1992 Sep;65(777):737-53. doi: 10.1259/0007-1285-65-777-737. No abstract available.
Schultheiss TE, Stephens LC, Jiang GL, Ang KK, Peters LJ. Radiation myelopathy in primates treated with conventional fractionation. Int J Radiat Oncol Biol Phys. 1990 Oct;19(4):935-40. doi: 10.1016/0360-3016(90)90015-c.
Schultheiss TE, Stephens LC, Maor MH. Analysis of the histopathology of radiation myelopathy. Int J Radiat Oncol Biol Phys. 1988 Jan;14(1):27-32. doi: 10.1016/0360-3016(88)90046-6.
Other Identifiers
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T0408240012
Identifier Type: -
Identifier Source: secondary_id
F050103003
Identifier Type: -
Identifier Source: org_study_id