Treatment of Resectable Malignant Brain Tumors
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|ClinicalTrials.gov Identifier: NCT00415467|
Recruitment Status : Terminated (Sponsor decision to terminate study.)
First Posted : December 25, 2006
Last Update Posted : August 2, 2012
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 or disease||Intervention/treatment||Phase|
|Brain Tumor||Device: GliaSite Radiation Therapy System||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase IV GliaSite® Radiation Therapy System Registry Protocol for the Treatment of Resectable Malignant Brain Tumors|
|Study Start Date :||January 2005|
|Actual Primary Completion Date :||November 2007|
|Actual Study Completion Date :||July 2008|
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
- 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.
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT00415467
|United States, Texas|
|U.T.M.D. Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Anita Mahajan, MD||M.D. Anderson Cancer Center|