Comparing 2 Forms of Head Immobilization for Stereotactic Radiotherapy

This study is currently recruiting participants.

Verified by Thomas Jefferson University, April 2007

Sponsored by:	Thomas Jefferson University
Information provided by:	Thomas Jefferson University
ClinicalTrials.gov Identifier:	NCT00328510

Purpose

To determine which head holder device will better hold the head for accuracy of delivering radiation treatments

Condition	Intervention	Phase
Patients Receiving Fractionated Steretactic Radiotherapy for Brain Tumors	Device: GTC frame and thermoplastic mask	Phase III

MedlinePlus related topics: Brain Cancer Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
Official Title:	A Randomized Trial Comparing Two Forms of Immobilization of the Head for Fractioned Stereotactic Radiotherapy

Further study details as provided by Thomas Jefferson University:

Primary Outcome Measures:

Estimates of and tests for the extent to which the two
methods of immobilization differ from ideal in either mean or variability.

Estimated Enrollment:	80
Study Start Date:	February 2005
Estimated Study Completion Date:	April 2008

Detailed Description:

To compare the efficacy of two commonly used, generally accepted forms of immobilization for the treatment of lesions in the head with fractioned stereotactic radiotherapy. Specifically, this study will use the ExacTRAC kilovoltage imaging system to assess positioning accuracy for these two systems. By measuring how the patient’s head position on a particular treatment day differs relative to the geometry that existed

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients who are eligible for fractionated stereotactic radiotherapy

Exclusion Criteria:

Severe claustrophobia

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00328510

Contacts

Contact: Greg Bednarz, PhD	215-955-6345	greg.bednarz@mail.tju.edu
Contact: Roseann Bonanni, CCRP	215-955-8619	roseann,bonanni@mail.tju.edu

Locations

United States, Pennsylvania
Jefferson Hospital for the Neurosciences	Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Greg Bednarz, PhD 215-955-6345 greg.bednarz@mail.tju.edu
Contact: Maria Werner-Wasik, MD 215-955-6705 maria.werner-wasik@mail.tju.edu
Principal Investigator: Greg Bednarz, PhD

Sponsors and Collaborators

Thomas Jefferson University

Investigators

Principal Investigator:

Greg Bednarz, PhD

Thomas Jefferson University

More Information

Related Info This link exits the ClinicalTrials.gov site

Study ID Numbers:	04U.534
Study First Received:	May 19, 2006
Last Updated:	April 23, 2007
ClinicalTrials.gov Identifier:	NCT00328510
Health Authority:	United States: Institutional Review Board

Keywords provided by Thomas Jefferson University:

Stereotactic radiotherapy

Study placed in the following topic categories:

Brain Neoplasms
Central Nervous System Diseases
Central Nervous System Neoplasms
Brain Diseases
Nervous System Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Nervous System Diseases

ClinicalTrials.gov processed this record on January 15, 2009