A Study of Spinal Radiosurgery - Full Text View

Sponsors and Collaborators:	University of Alabama at Birmingham Health Services Foundation The Kirklin Clinic at Acton Road
Information provided by:	University of Alabama at Birmingham
ClinicalTrials.gov Identifier:	NCT00573872

Purpose

Phase I of the study (motion and quality assurance [QA] study) is being used to determine intrafraction target motion and define quality assurance procedures for single fraction spinal radiosurgery. The Phase II portion of the study is being used to estimate the palliative response (pain or relief of neurologic symptoms) and local control for single fraction radiosurgery delivered with TomoTherapy and to assess the acute and late toxicity of spinal radiosurgery.

Condition	Intervention	Phase
Neoplasm Arteriovenous Malformations	Radiation: Radiosurgery	Phase I Phase II

MedlinePlus related topics: Arteriovenous Malformations Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Active Control, Single Group Assignment
Official Title:	A Phase II Study of Spinal Radiosurgery

Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:

To determine intrafraction target motion and define quality assurance procedures for single fraction spinal radiosurgery [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To estimate the palliative response (pain or relief of neurologic symptoms) and local control for single fraction radiosurgery delivered with Tomotherapy [ Time Frame: 2 years ] [ Designated as safety issue: No ]
To assess the acute and late toxicity of spinal radiosurgery [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	36
Study Start Date:	April 2005
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Intervention Details:

Phase I: 20-25 Gy in 5 fractions Phase II: 9-24 GY in 1 fraction

Detailed Description:

Optimal radiation plan is generated that treats the tumor (CTV) and spares normal tissue, especially the spinal cord. Motion and QA study will determine intrafraction motion for phase II portion of the study. 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

Eligibility

Ages Eligible for Study:	19 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

All subjects must have history of histologically confirmed neoplasm or radiographically-diagnosed AVM. Patients without a prior tissue diagnosis but who have a radiographically characteristic lesion are eligible if there is consensus agreement of the diagnosis in the UAB Neuro-oncology Tumor Board.
ECOG performance status of less than or equal to 2
Age greater than 18
Life expectancy greater than 12 weeks
Subjects given written informed consent

Exclusion Criteria:

Cytotoxic chemotherapy within 7 days of treatment
Insufficient recovery from all active toxicities of prior therapies
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.
Patient is non-ambulatory. Optimization of pretreatment neurologic function with steroids is allowed. Ambulation with assistance of walker or cane is allowed.
Patient is pregnant and it is judged by the treating Radiation Oncologist that spinal radiosurgery would place the fetus in unacceptable danger.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00573872

Contacts

Contact: Latania Oldham, RN, BSN, OCN	205-975-2880	loldham@uabmc.edu
Contact: Teresa Ross, RN	205-978-0250	tross@uabmc.edu

Locations

United States, Alabama
University of Alabama at Birmingham/The Kirklin Clinic at Acton Road	Recruiting
Birmingham, Alabama, United States, 35233
Contact: Teresa Ross, RN 205-978-0250 tross@uabmc.edu
Contact: Latania Oldham, RN, BSN, OCN 205-975-2880 loldham@uabmc.edu
Principal Investigator: John Fiveash, M.D.
Sub-Investigator: James A. Bonner, M.D.
Sub-Investigator: Sharon Spencer, M.D.
Sub-Investigator: Jennifer De Los Santos, M.D.
Sub-Investigator: Robert Nordal, M.D.
Sub-Investigator: Barton Guthrie, M.D.
Sub-Investigator: James Market, M.D.
Sub-Investigator: Richard Morawetz, M.D.
Sub-Investigator: Paul Matz, M.D.

Sponsors and Collaborators

University of Alabama at Birmingham

Health Services Foundation

The Kirklin Clinic at Acton Road

Investigators

Principal Investigator:

John B. Fiveash, M.D.

University of Alabama at Birmingham

More Information

Publications:

Abbatucci JS, Delozier T, Quint R, et al: Radiation myelopathy of the cervical spinal cord: time, dose and volume factors. Int J Radiat Oncol Biol Phys 4:239-248, 1978

Ang KK, Jiang GL, Feng Y, et al: Extent and kinetics of recovery of occult spinal cord injury. Int J Radiat Oncol Biol Phys 50:1013-1020, 2001

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.

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.

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.

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. Review. No abstract available.

Schultheiss TE, Stephens LC, Jiang GL, et al: Radiation myelopathy in primates treated with conventional fractionation. Int J Radiat Oncol Biol Phys 19:935-940, 1990

Schultheiss TE, Stephens LC, Maor MH: Analysis of the histopathology of radiation myelopathy. Int J Radiat Oncol Biol Phys 14:27-32, 1988

Responsible Party:	University of Alabama at Birmingham ( John Fiveash, M.D. / Assistant Professor of Medicine )
Study ID Numbers:	F050103003, T0408240012
Study First Received:	December 12, 2007
Last Updated:	February 12, 2009
ClinicalTrials.gov Identifier:	NCT00573872 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Alabama at Birmingham:

Radiosurgery
Phase II
Cancer
Spinal
AVM

Study placed in the following topic categories:

Cardiovascular Abnormalities
Aneurysm
Vascular Malformations
Vascular Diseases

Hemangioma
Arteriovenous Malformations
Congenital Abnormalities

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Cardiovascular Abnormalities
Aneurysm
Vascular Malformations
Neoplasms, Vascular Tissue

Vascular Diseases
Hemangioma
Cardiovascular Diseases
Arteriovenous Malformations
Congenital Abnormalities

ClinicalTrials.gov processed this record on May 07, 2009