A Study of Spinal Radiosurgery (RAD0408)

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborators:

Health Services Foundation

The Kirklin Clinic at Acton Road

Information provided by (Responsible Party):

John Fiveash, MD, University of Alabama at Birmingham

ClinicalTrials.gov Identifier:

NCT00573872

First received: December 12, 2007

Last updated: January 23, 2013

Last verified: January 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

December 12, 2007

Last Updated Date

January 23, 2013

Start Date ^ICMJE

April 2005

Estimated Primary Completion Date

August 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00573872 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

A Study of Spinal Radiosurgery

Official Title ^ICMJE

A Phase II Study of Spinal Radiosurgery

Brief Summary

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.

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

Study Type ^ICMJE

Interventional

Study Phase

Phase 1
Phase 2

Study Design ^ICMJE

Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Neoplasm
Arteriovenous Malformations

Intervention ^ICMJE

Radiation: Radiosurgery

Phase I: 20-25 Gy in 5 fractions

Phase II: 9-24 GY in 1 fraction

Study Arm (s)

Not Provided

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

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2013

Estimated Primary Completion Date

August 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

19 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00573872

Other Study ID Numbers ^ICMJE

F050103003, T0408240012

Has Data Monitoring Committee

Yes

Responsible Party

John Fiveash, MD, University of Alabama at Birmingham

Study Sponsor ^ICMJE

University of Alabama at Birmingham

Collaborators ^ICMJE

Health Services Foundation
The Kirklin Clinic at Acton Road

Investigators ^ICMJE

Principal Investigator:

John B. Fiveash, M.D.

University of Alabama at Birmingham

Information Provided By

University of Alabama at Birmingham

Verification Date

January 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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