A Study of Spinal Radiosurgery - Tabular View

Tracking Information

First Received Date ^ICMJE

December 12, 2007

Last Updated Date

November 2, 2009

Start Date ^ICMJE

April 2005

Estimated Primary Completion Date

December 2009 (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

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 Phase

Phase I, Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Open Label, Active Control, Single Group Assignment

Condition ^ICMJE

Neoplasm
Arteriovenous Malformations

Intervention ^ICMJE

Radiation: Radiosurgery

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2011

Estimated Primary Completion Date

December 2009 (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: Latania Oldham, RN, BSN, OCN	205-975-2880	loldham@uabmc.edu
Contact: Teresa Ross, RN	205-978-0250	tross@uabmc.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00573872

Responsible Party

John Fiveash, M.D. / Assistant Professor of Medicine, University of Alabama at Birmingham

Study ID Numbers ^ICMJE

F050103003, T0408240012

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

November 2009

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