Treatment of Resectable Malignant Brain Tumors - Full Text View

Sponsored by:	M.D. Anderson Cancer Center
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00415467

Purpose

The goals of this study are to evaluate each of the following items:

Time to recurrence in patients receiving brachytherapy with the GliaSite RTS
Overall survival (OS) in patients with malignant brain tumors who are undergoing surgical resection and brachytherapy treatment with the GliaSite® Radiation Therapy System (RTS).
Incidence of serious adverse events in patients treated with GliaSite RTS

Condition	Intervention	Phase
Brain Tumor	Device: GliaSite Radiation Therapy System	Phase IV

MedlinePlus related topics: Brain Cancer Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase IV GliaSite® Radiation Therapy System Registry Protocol for the Treatment of Resectable Malignant Brain Tumors

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

The goal of this clinical research study is to learn more about the safety, performance, and effectiveness of the GliaSite Radiation Therapy System (RTS) when used for patients with malignant brain tumors. [ Time Frame: 4 Years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	300
Study Start Date:	January 2005
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental GliaSite Radiation Therapy System (RTS)	Device: GliaSite Radiation Therapy System Radiation delivery system that provides brachytherapy targeted to a specific site in the brain, to see its effects to the surrounding area where the tumor was located.

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Eligibility

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

Criteria

Inclusion Criteria:

Patient must have histologically proven malignant brain tumor
Patient must be a candidate for surgical resection of the tumor mass.
Patient must not be pregnant or breast-feeding. All patients with the potential for pregnancy should be counseled and requested to follow acceptable birth control methods to avoid conception.
Patient must sign informed consent form

Exclusion Criteria:

1) Serious concurrent infection or medical illness which could jeopardize the ability of the patient to receive the GliaSite catheter with reasonable safety.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00415467

Locations

United States, Texas
U.T.M.D. Anderson Cancer Center
Houston, Texas, United States, 77030

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators

Principal Investigator:

Anita Mahajan, MD

U.T.M.D. Anderson Cancer Center

More Information

Responsible Party:	U.T.M.D. Anderson Cancer Center ( Anita Mahajan, MD/Associate Professor )
Study ID Numbers:	2003-0942
Study First Received:	December 22, 2006
Last Updated:	January 25, 2008
ClinicalTrials.gov Identifier:	NCT00415467
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

Brain Tumor
Radiation Therapy System
GliaSite RTS

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 16, 2009