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Treatment of Resectable Malignant Brain Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00415467
Recruitment Status : Terminated (Sponsor decision to terminate study.)
First Posted : December 25, 2006
Last Update Posted : August 2, 2012
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:

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

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

Condition or disease Intervention/treatment Phase
Brain Tumor Device: GliaSite Radiation Therapy System Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase IV GliaSite® Radiation Therapy System Registry Protocol for the Treatment of Resectable Malignant Brain Tumors
Study Start Date : January 2005
Primary Completion Date : November 2007
Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Brain Tumors
U.S. FDA Resources

Arm Intervention/treatment
Experimental: GliaSite Radiation Therapy System (RTS)
Surgical removal of brain tumor followed by GliaSite RTS targeted brachytherapy to the specific brain tumor site
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.
Other Name: GliaSite RTS

Primary Outcome Measures :
  1. Time to Recurrence of Brain Tumor (anywhere in brain) [ Time Frame: From brachytherapy to assessments at 1 and 3 months after brachytherapy then every 3 months after that or until documented brain tumor recurrence. ]
    Time to recurrence of brain tumor determined for each patient from the time at the end date of brachytherapy with the GliaSite RTS until the date of documented brain tumor recurrence.

Secondary Outcome Measures :
  1. Overall Patient Survival [ Time Frame: Time from completion of the GliaSite procedure to death by any cause (time in months). ]
    Overall survival determined as time from end date of brachytherapy with the GliaSite RTS until the date of death, including occurrences of death due to CNS causes and by deaths due to non-CNS causes. In the time to event analyses, if the event is not reached, participant censored at last date known to be without the event of interest (recurrence-free or alive). Median time-to-event determined by Kaplan-Meier methods.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Patient must have histologically proven malignant brain tumor
  2. Patient must be a candidate for surgical resection of the tumor mass.
  3. 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.
  4. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00415467

United States, Texas
U.T.M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Principal Investigator: Anita Mahajan, MD M.D. Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00415467     History of Changes
Other Study ID Numbers: 2003-0942
First Posted: December 25, 2006    Key Record Dates
Last Update Posted: August 2, 2012
Last Verified: August 2012

Keywords provided by M.D. Anderson Cancer Center:
Brain Tumor
Radiation Therapy System
GliaSite RTS

Additional relevant MeSH terms:
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases